Population Reports
SERIES H NUMBER 3 JANUARY 1975 BARRIER MElHODS
Department of Medical and Public Affairs, The George Washington University Medical Center, 2001 S Street, NW., Washington, D.C. 20009
Vaginal Contraceptives This report on vaginal chemical contraceptives was prepared by Raymond Belsky, B.S.E.E., and A Time for Reappraisal? the staff of the Population Information Program, George Washington University (USA), on the basis of published papers, unpublished studies, and dis Vaginal chemical contraceptives deserve a second look. cussions with individual investigators. Until the advent of oral contraceptives and IUDs in the 1960s, creams, jellies, and suppositories were widely used, The assistance of S. A. Baker, Elizabeth Connell, both with and without diaphragms and condoms. Then, E. C. Corderoy, John D. Cutler, Henry Elkins, vaginal contraceptive use declined. But in the last few Thomas Gingrich, Norman Hardy, H. D. Herbrand, years more effective foam preparations and more conven Louis Keith, Richard Lincoln, Fuhmio Ohneda, ient packaging have been developed. This product improve Malcolm Potts, Edward Sargent, Jerome J . Siegel, ment. coupled with the need for contraceptives that can be AquilesJ. Sobrero, J. Joseph Speidel, and Armond disseminated through nonmedical channels, suggests that M . Welch in reviewing this report is greatly appre vaginal contraceptives can still playa useful role in family ciated. Frances G. Conn is Executive Editor. Com planning programs. ments, letters, and updated material are welcome.
Vaginal chemical contraceptives, sometimes called spermicides or topical contraceptives, are made of rela tively inert base materials which physically block sperm woman-years of use-have been reported in several recent plus active spermicidal agents which chemically immobilize studies in the US (see Page H-45). or destroy sperm. One of the oldest forms of contraception, these preparations remain the only method of birth control There are other factors which limit wide-spread popularity used exclusively by a woman which does not require medi and distribution of chemical contraceptives. As with all cal intervention or produce systemic effects. Vaginal con coitus-dependent methods, these preparations must be traceptives, like condoms, can be distributed in many used almost immediately before intercourse, which inter ways-by smal'l stores, bazaars, door-to-door salesmen, rupts lovemaking. They must be inserted high into the vending machines, as well as in clinics or registered phar vagina, which some women may be reluctant to do. They macies. The cost ranges from about $.02 (US) to $.45 (US) must be reinserted for repeated acts of intercourse. They per application. may cause mild burning or irritation in some women. In the tropics, many of these preparations require special The major drawback of vaginal methods is the relatively protection against heat and humidity. Other difficulties, high failure rate. Compared with users of pills, IUDs, and including cost, transportation, and promotion, inhibit even condoms, the users of vaginal contraceptives have a commercial distribution, especially in the rural areas of high incidence of accidental pregnancy. A US survey in developing countries. 1970 showed that, among couples practicing contraception for the purpose of either delaying or preventing pregnancy, If, however, the wide-spread medical skepticism about 31 percent of foam users experienced an unplanned preg nonprescription methods of fertility control could be over nancy during the first 12 months of use as compared with come, these problems might also be solved. Certainly there 6 percent of the pill users, 8 percent of the IUD users, are many parts of the world in which long standing folk 17 percent of the condom users, and 33 percent of the rhythm users (135) (see Page H-39).
Inconsistent Use a Problem CONTENTS The higher failure rates for methods like condoms, vaginal History ...... H-38 contraceptives, and rhythm are usually attributed to incon Mode of Action ...... H-40 sistent use of the method rather than to failure of the Effectiveness ...... H-44 method during use. As far as vaginal methods are con Use and Distribution ...... , H-47 cerned, recent clinical studies suggest that the new prepa Venereal Disease Prophylaxis ...... H-50 rations, particularly foams in aerosol, or pressurized, con Bibliography ...... H-52 tainers, can provide substantial protection if used regularly and correctly. Low pregnancy rates-i.e., below five per 100
Part 1 of 3 parts - January 1975 mailing H-37 B.C. Aristotle described the use of oil of cedar and frank incense in olive oil to block the cervical os. Peppermint Population Reports is published bi-monthly at 2001 juice mixed with honey was mentioned by Dioscarides in S Street, N.W., Washington, D.C. 20009, USA, by the 1 st century AD. Soranos, in his 2nd century classic the Population Information Program, Science Com Gynaecology, lists oil, honey, cedar gum, various fruit munication Division, Department of Medical and acids, and astringents like alum (76). Since environments Public Affairs of The George Washington University that are either strongly acid or strongly alkaline are hostile Medical Center and is supported by the United to sperm, these early paste and chemical barriers probably States Agency for International Development, P. T. did have some effect in limiting fertility. Salt in an 8 per Piotrow, Ph.D., Director. Application to mail at cent solution, for example, is highly spermicidal. second class postage rates is pending at Washing ton, D.C. During the middle ages, rock salt and alum were frequently used as vaginal contraceptives. Indian writers in the 8th century described rock salt dipped in oil or honey as a con traditions support vaginal contraception, making this ap traceptive. Moslem physiCians in the 12th century recom proach more acceptable at first than more modern tech mended suppositories or tampons containing rock salt, niques. alum, or various fruit and herb juices. In Europe, a sponge moistened with diluted lemon juice and inserted into the Useful Adjunct Methods vagina was cited in 1732 as an effective traditional No one today would advocate a family planning program fnethod (76). emphasizing vaginal contraceptives as the primary method of fertility regulation. The question is whether these prepa Coitus interruptus was widely practiced by the rural popu rations fit into modern family planning programs in asso lation in Europe during the 18th and 19th centuries. As ciation with other methods and, if so, how. For example, the rapid population growth which accompanied the In- vaginal contraceptives are sometimes recommended for use with the IUD during the first few months after insertion and with condoms during the most fertile time of the month. During lactation they can reinforce the contracep tive effect of breastfeeding. The lack of systemic reaction makes vaginal contraceptives suitable for women who have had side effects with oral contraceptives or IUDs.
For young couples, vaginal methods can provide a simple introduction to contraception. At the other end of the age spectrum, women approaching menopause may find many of these products provide welcome vaginal lubrication as well as protection against a late pregnancy. At all ages women who have intercourse infrequently or women who have forgotten to take oral contraceptives regularly can find in vaginal contraceptives the occasional protection that is needed.
Laboratory tests have shown that all vaginal contraceptives currently in use inhibit, in varying degrees, the growth of venereal disease organisms. Clinical studies now underway in the United States will determine whether in practice women using vaginal preparations can expect similar pro tection against VD.
Most important from the point of view of current distribu tion facilities, vaginal contraceptives require no supervision by health personnel. Convenient packaging and simple graphic instructions are possible. In short, although vagi nal chemical preparations will certainly never replace oral contraceptives, sterilization, IUDs, and condoms, they can serve as a convenient back-up or alternative techniques.
Fig. 1. Examples of Various Vaginal Contraceptives HISTORY Top row (I-r): Antemin Cream (UK), Immolin Cream Jel (USA), Neo Sampoon Loop Foam Tablets (Japan), The insertion of pastes, jellies, and various mixtures into CCC Foam Tablets (Japan) the vagina in order to prevent conception is surely among the oldest and simplest methods of fertility control. As Middle row (I-r); Emko Foam (USA), Delten Foam (USA). C-Film (Switzerland) early as the 19th century B.C. the Egyptians were mixing honey, natron (sodium carbonate), and crocodile dung to Bottom row (I-r): Rendells Suppositories (UK). CCC form a vaginal contraceptive paste. In the 4th century Jelly (Japan), Gynomin Foaming Tablets (UK)
H-38 dustrial Revolution brought people to the cities, additional phragm, invented in 1882 by Dr. W ilhelm Mensinga, and forms of contraception became accessible through the of cream bases for use either alone or with devices fitted by marketplace. The first commercial vaginal contraceptive physicians. During t he 1920s and 1930s, numerous vagi was developed in 1885 by Walter Rendell, an English nal suppositories and foaming tablets, many containing pharmacist. who prepared a suppository of soluble cocoa organo-met all ic compounds such as mercury, quinine, butter plus quinine sulfate (7). (Quinine sulfate was re chinosol, lactic acid, boric acid, or burnt alum, were placed by hydroqu inone, a more potent spermicide, in marke ted in the United States and Europe. Beca use many 1939 when it was discovered that the spermicidal effect of physicians still refused to advise on or recommend birth quin ine su lfate was impaired by cocoa butter.) control, vaginal contraceptives w ere sold primarily over the counter or by mail to consumers who were not protected by In the late 19th century, Annie Besant, t he English feminist any official standards of safety or effectiveness. leader who challenged laws prohibiting the distribution of contrace ptive information, was recommending a sponge Today in ma ny parts of the w orld homemade vaginal soaked in Quin ine solution as a spermicida l vaginal bar methods and simple spermicides are still used. A tampon rier. Severa l Dutch physicians in the late 1880s recom of cotton waste and m ustard oil, for exa mple, is popular mended va ginal pl ugs made from soap. In 1895, W. P. in so me regions of India, and douch es of Coca-Cola, which Chu nn in the United States suggested va ginal suppositories is moderately acid and spermicidal, have reportedly served of coconut butter with boric acid, tannic acid, or bichloride the same purpose elsewhere (130,132). of merc ury (76). Together w ith coitus interruptus, these vaginal methods, both homemade and commercial, w ere widely used before the development of latex rubber per Surface Active Agents mitted mass manufacture of cheap reliable condoms. Compared w ith the volume of research required in recent years to develop steroidal contraceptives and IU Ds, rela Grad ual recogn ition by the medical profession of the need tively little study has been devoted to sperm icidal prepara for more reliable forms of contraception spurred the devel tions. The modern trend has been toward vagi nal contra opment of spermicidal jellies to be used with the dia ceptives which combine a spermicidal agent of proven
50 ~------,
Percent intending to delay pregnancy who failed to do so .
o Percent intending to prevent pregnancy who failed to do so.
40 0 Percent intending to delay or prevent pregnancy who failed to do so.
30
20
10
o Pill IUD Condom Diaphragm Foam Rhythm Douche Method
Fig. 2. Percent of Couples Failing to Delay or Prevent an Unwanted Pregnancy in the First Year of Exposure, by Method and Intent. Source: Ryder (135).
H·39 potency with a base material, or vehicle, as it is usually Hotay developed a water-soluble plastic (polyvinyl alcohol) called, that will dissolve or disperse rapidly throughout the film as a base for the spermicide cetyl pyridinium bromide vagina and not irritate either the woman or her partner. (CPB). He called this C-film (72). With nonoxynol-9 as the spermicide, C-film is now patented by USV Pharmaceutical At the same time, concern for toxicity and consumer safety Corporation and licensed for manufacture and sale by a has led some manufacturers to eliminate possibly haz British, a Swiss, and an Italian drug firm. Studies are being ardous compounds, such as mercury and hydroquinones, conducted in a number of European countries, and C-film from vaginal contraceptive products. Other substances is sold in Britain as an adjunct contraceptive method. which offer greater surface action and are less likely to be irritating, absorbed systemically, or harmful to a fetus have been substituted.
A critical development in the early 1950s was the discovery MODE OF ACTION that surface active agents (surfactants) such as nonyl phenoxy polyethoxy ethanol (nonoxynol-9) were effective There are four basic types of chemical contraceptives used spermicides. Unlike many of the earliest commercial formu vaginally-creams, jellies, and pastes, which are squeezed lations, these are neither strongly acidic nor irritating to the vagina. They are increasingly used as the principal from a tube; suppositories; foams, either in tablet form or active ingredients in modern preparations (see Table 1). pressurized containers; and soluble films (see Table 2). Each preparation has two components: a relatively inert carrier base or vehicle and an active spermicidal agent. All Application and Packaging operate both mechanically, by forming a barrier to delay sperm progression, and biochemically, by immobilizing or Not only the ingredients themselves, but also the methods destroying the sperm which have been blocked. of application and packaging have been changed and im proved. In the early 1930s chemical suppositories and Products squeezed from a tube include creams, jellies, foaming tablets were inserted with the fingers. By the late and pastes. These diHer mainly in physical characteristics. 1940s plastic applicator tubes with plungers were devel Jellies a nd pastes are made from a variety of water-soluble oped so that jellies could be inserted high in the vagina. bases, such as gelatin or gum tragacanth. The base material When vaginal creams were introduced in the mid-1950s, and spermicide incorporated within it liquify at body the same applicator design was used. In recent years, temperatures and disperse rapidly when they come in con single-dose tampon-shaped applicators, pre-filled at the tact with vaginal secretions. About four or five grams of factory and disposable after use, have been developed. jelly or paste are squeezed from the tube into a special applicator used to insert the product into the vagina. In the late 1950s Joseph Sunnen, a St. Louis manufacturer and family planning enthusiast, developed Emko, a vaginal Creams, on the other hand, are made from water-insoluble contraceptive foam containing nonoxynol-9 and ben fats, such as stearates or glycerin, which are compounded zethonium chloride in a pressurized container. It was first into an emulsion with the active spermicide dissolved in marketed in 1961. Ortho Pharmaceuticals followed with the aqueous portion (72). These preparations tend to re Delfen contraceptive foam in 1963. main wherever they are discharged into the vagina and not to disperse further. Thus correct positioning of the The first foams came in glass bottles. Because foam could applicator is important. Creams provide protection within not be discharged directly into the vagina, single-dose two to three minutes after application. Like jellies, they are applicators like those for creams and jellies were included. packaged in tubes and require special applicators. The applicator had to be filled just before coitus, sincefoam in the applicator lost its stability and became liquid after Suppositories, sometimes called pessaries or vagitories, several hours. Most foams are still applied this way. are either water-soluble gelatin-based or water-insoluble wax-based. They are designed to dissolve at body tempera In 1970 Emko introduced a single-dose applicator which ture, releasing active agents which, if placed high in the the user can fill as much as one week in advance. The vaginal canal, will coat the cervix and vagina. For optimal preparation is transferred from the can to the applicator as effectiveness, most suppositories should be inserted about a liquid which, when applied, becomes foam in the vagina. 15 minutes before coitus. Spermicidal action then lasts Emko marketed a tampon-shaped container-applicator in about 20 minutes to one hour. Special packaging is re 1974. Factory-filled with six premeasured doses, it remains quired to prevent damage from heat and humidity. ready for use indefinitely and produces foam upon applica tion. The cost is high, about $1 .80 (US) for six applications, Foam products are available in tablet form or in pres but it may be reduced in time. surized containers. Foam tablets usually consist of tartaric acid and bicarbonate of soda with a powder base in which the spermicide is incorporated. In the presence of vaginal In Japan, the Eisai Company has developed small foam secretions carbon dioxide is released, generating foam. tablets with a new surface active agent, p-methanyl This takes from three to ten minutes depending on the phenyl polyoxyethylene (8.8) ether, commonly called product. Some manufacturers recommend moistening the TS-88. The tablets are round with a hole in the center tablet with a small amount of saliva or water before in and look somewhat like white Life-Saver candies. They serting it, so that foaming action is hastened. As the foam foam quickly and have a strong spermicidal effect. carrying the spermicide disperses over a broad surface area of the vagina, it produces a discernible amount of heat. No Water-soluble contraceptive fi 1m is the newest form of special applicator is needed, but moisture-proof packaging vaginal contraceptive. In Hungary several years ago is required.
H-40 Table 1-Active Ingredients in Selected Vaginal Contraceptives, 1973-1974
Surface active agents 1 Bactericides Acids
o It) (5 It) c: ~ > (5 .. u x u -5 o ~ o > ., .!!! "£
Isurface active agents may also possess bactericidal properties. 2use with diaphragm recommended by manufacturer.
SOU RCE: Physician's Desk Reference, 1973; American Medical Association Bureau of Drugs; product labels and in serts; and personal communications with manufacturers.
HAl Pressurized foam products, com monly called aerosol trated form, some of these agents may also be effective foams, consist of an oil and water emulsion stored under against common vaginal infections such as trichomoniasis gas pressure. The liquefied gas propellant, w hen released, or monoliasis, but t here is no evidence that they have a produces the foam. Depending on the type of container, the significant bacter icidal effect in normal contraceptive use. foam is either released into an applicator or, in newer de signs, discharged d irectly into the vagina, where the foam disperses w idely and provides immediate protection. Highly acidic agents most likely to be used as sperm icides Some foams can be inserted as much as one hour before include lactic acid, boric acid, tartaric and citric acids, coitus. and gum acacia, w hich w as also used in ancient Greecefor blocking the cervix. Sometimes small quantities of acidic agents are used in addition to other spermicidal ingredi Soluble films use polyvinyl alcohol and glycerine, sodium ents. carboxymethyl cellulose (CMC), or rice paper to carry spermicides. C-f ilm is a four em sq uare piece of trans parent, w ater-sol uble, paper-like plastic impregnated with Quality Control and Safety nonoxynol-9 . It requires no special applicator but is folded Spermicides pose gen uine problems in drug regulation. once and inserted into t he vagina by hand. C-film should be Many products now in use were introduced before any placed in the vagina 30 minutes before coitus (98). nation developed sophisticated regulatory authorit ies_ In Britain, for example, most products have a license " as of right" from the Comm ittee for Safety of Medicines, which Although La gap SA. the Sw iss manufacturer, suggests in its w ill review them according to a set timetable. Although packa ge insert that C-film can also be placed over the peniS some tests for spermicidal effectiveness have been devel before coitus like a condom , this technique is not con oped, few tests have been made to evaluate safety. Lack of sidered highly effective (1 ). reported adverse effects during past use is the primary argument for the safety of existing formulations, but any Other films are made of different substances. For example, new prod ucts, such as C-film, will undoubtedly be subjected one Italia n contraceptive film uses rice paper as its base; to m uch closer scrutiny. an Indian film uses urea as the spermicide although its potency is doubtful (70, 132 ). Before use soluble film con Biologically, a spermiCide could damage the genetic ma traceptives must be protected against humidity and terial in the sperm head without killing the sperm and lead moisture. to abnormalities after fertilization, or it could be absorbed in m inute quantities and damage the woman or the devel Biochemical Action oping fetus. The former is unproven and the latter has been investigated only w ith regard to certain mercury com The ingredients w hich determine a particular product's pounds. Although there are no studies or data showing that spermicidal or biochemical action may be predominately phenyl mercuric acetate (PMA) or any other compounds surface active, bactericidal, or high ly acidic. Frequently used in vaginal contraceptives have adversely affected two or more of these ingredients are combined in a single human users, there are ample data proving the toxicity and product (see Table 1). teratogenicity of other mercury compounds such as methyl mercury (110,118,156,176). Moreover, there is at least Surface active agents are believed to attach themselves one Japanese study which showed fetal abnormalities in to the spermatozoa, inhibiting oxygen uptake and fructoly albino mice ranging from three to five times higher than in sis (the splitting up of fructose -sugar). Their primary control groups when a portion of a contraceptive tablet action is in breaking down the sperm wall (15). The sim containing PMA was introduced in the vagina on the plest explanation, as Hardy and Wood put it, is that "they seventh day of pregnancy. In addition to these fetal abnor reduce the surface tension at the cell surface and thus in malities, which involved primarily the central nervous sys directly kill the spermatozoa by osmotic imbalance" (72). tem, pathological changes suggestive of acute mercury Among the most commonly used surface active agents are: poisoning were observed in the livers and kidneys of the nonylphenoxy polyethoxy ethanol (nonoxynol-9), p mothers (113). To avoid this danger altogether and also to diisobutyl phenoxy polyethoxy ethanol, methoxy polyoxy avoid the necessity of extensive testing to guarantee ethylene glycol 550 laurate, and p-methanylphenyl poly safety, a number of manufacturers have substituted sur oxyethylene (8.8) ether (TS-88) (see Table 1). face active agents for the organo-metallic compounds that were used initially.
The bactericidal agents used most frequently as spermi In the USA, the Food and Drug Administration (USFDA) cides are phenyl mercuric acetate (PMA), quinine com has established an advisory panel, chaired by Dr. Elizabeth pounds, quartenary compounds, and ricinoleic acid and its Connell, to review the safety, effectiveness, and labelling compounds. They act by combining with the sulfur and of over-the-counter drugs for human use including over hydrogen bonds within the spermatozoa, thus disrupting the-counter contraceptives and other vaginal drug prod their metabolism (72). Actually the distinction between sur ucts (168). Although the panel has reached nofinal conclu face active and bactericidal is not always clear since some sions, the following standards have been promulgated by bactericides act by altering the surface characteristics and the USFDA "to determine general recognition that a cate potency of bacteria (13,17,37). Surfactants and bacteri gory of OTC drugs is safe and effective ..." (1 67). cides together often have a synergistic effect, making the combined product a more effective spermicide than any (i) Safety means a low incidence of adverse reactions or one of the ingredients alone. Administered under direct significant side effects under adequate directions for use and medical supervision at frequent intervals or in concen warnings against unsafe use as well as low potential for
H-42 harm which may result from abuse under conditions of wide by partially controlled or uncontrolled studies, documented spread availability. Proof of safety shal l consist of adequate clinical studies by qualified experts, and reports of sig tests by methods reasonably applicable to show the drug is nificant human experience during marketing. Isolated case safe under the prescribed, recommended, or suggested con reports, random experience, and reports lacking the details ditions of use. This proof shall include results of significant which permit scientific evaluation will not be considered. human experience during marketing. General recognition of General recognition of effectiveness shall ordinarily be safety shall ordinarily be based upon published studies based upon published studies which may be corroborated which may be corroborated by unpublished studies and by unpublished studies and other data. other data. (iii) The benefit-to-risk ratio of a drug shall be considered in determining safety and effectiveness. (ii) Effectiveness means a reasonable expectation that, in a significant proportion of the target population, the phar (iv) An aTC drug may combine two or more safe and effec macological effect of the drug, when used under adequate tive active ingredients and may be generally recognized as directions for use and warnings against unsafe use, will safe and effective when each active ingredient makes a con provide clinically significant relief of the type claimed. tribution to the claimed effect(s); w hen combining of the ac Proof of effectiveness shall consist of controlled clinical tive ingredients does not decrease the safety or effectiveness investigations, unless this requirement is waived on the of any of the individual active ingredients; and w hen the basis of a showing that it is not reasonably applicable to the combination, when used under adequate directions for use drug or essential to the validity of the investigation and that and warnings against unsafe use, provides rational concur an alternative method of investigation is adequate to sub rent therapy for a significant proportion of the target pop stantiate effectiveness. Investigations may be corroborated ulation.
Table 2-Major Characteristics of Various Types of Vagi nal Chemical Contraceptives
Recommended minimum Duration of Type of Frequentlv Used Frequently Used Mode of Packaging interval Spermicidal Product Base Materials Act ive Ingred ientsl Application bet ween appllca · Effectiven8$S2 tion and co itus2
Jelly and Polyethylene Di·isobutylphen Tube Plastic appl icator 2·3 minutes 15 minutes· Paste glycol oxy poly 1 hour Gelatin ethoxy ethanol Gu m tragacan th POlyoxyethy lenenonyl phenol Phenyl mercuric acetate (PMA) I Cream I Stearates Nonoxynol-9 Tube or single Plastic applicator 2-3 minutes 10 minutes Stearic acid dose container 1 hour Glycerin Suppesi Refined cocoa Nonoxynol-9 Individual foil Manual insertion 3-15 minutes 20 m inutes tories butter Polyethylene- packages or with inserter 1 hour Stearines glycol of Soap monoisoctyl , Glycerin phenol ether Polysaccharide polysuffuric acid ester Foaming Bicarbona te TS·88 Vial or indio Manual insertion 3-10 minutes 30 minutes· tablets of soda Nonoxynol-9 vidual foil pac k 1 hour Polyethylene Chinosol glycol Polysaccharide· Glycerin polysulfuric Tartaric acid acid ester Chloramine Sodium dichlor osulphami dobenzoate Aerosol Hydrocarbon Nonox ynol-9 Aluminum or Plastic appl icator, None 30 minutes· foam and freon Benzethonium glass container single or mul tiple 1 hour Polyethylene chloride dose glycol I Glycerin Soluble Polyvinyl alco· Nonoxynol-9 Plas tic pouch Manual insertion 30 minutes N.A . film hoi contain ing after folding Glycerine cardboard ma tch· Rice paper book-like packet Sodium car· boxymethyl icellulose (CMC)
Isee also Table 1. 21nterval between appl ication and coitus and duration of spermicidal effectiveness vary among products of the same type. Also, researchers' recommendations for the same product may vary. N.A. =Not Available. H·43 (v) Labeling shall be clear and truthful in all respects and vagina can determine whether the spermicidal agent, how may not be false or mlsleading in any particular. It shall ever potent in vitro, will function effectively in vivo. Best state the intended uses and results of the product; adequate results were achieved with aerosol foams and creams. directions for proper use; and warnings against unsafe use, side effects, and adverse reactions in such terms as to render Using a point scoring method to evaluate contraceptive them likely to be read and understood by the ordinary in effectiveness at time periods ranging from a few seconds dividual, including individuals of low comprehension, under to eight hours after coitus, they found that only Delfen customary conditions of purchase and use. Cream (Ortho) and Emko Foam provided full protection after two injections of semen (87) (see Table 3). (vi) A drug shall be permitted for OTe sale and use by the laity unless, because of its toxicity or other potential for harmful effect or because of the method or collateral measures necessary to its use, it may safely be sold and used Sobrero's independent studies also confirm that, even only under the supervision of a practitioner licensed by law though foam apparently disappears during coitus, the to administer such drugs. spermicide is well distributed. It forms a highly potent coating or film which sperm must traverse if they are to penetrate the cervical canal (151).
Other formulations were less effective, Johnson and Mas ters found (86). Jellies did not disperse rapidly or thor EFFECTIVENESS oughly through the vagina, were excessively fluid, and sometimes caused irritation. Foam tablets varied widely Determining the effectiveness of spermicidal preparations in their dispersal capability, and some users complained of is a complex and sometimes controversial process. It begins vaginal irritations such as burning and itching sensations. in the laboratory and continues through animal, clinical, Suppositories often did not melt completely, causing an and even survey data to measure the actual use-effective insufficient distribution of the contraceptive within the ness of vaginal products as compared with other contracep vagina (86). tives. Even then there is disagreement about the best way to evaluate coitus-related methods since it is more often the user than the product which is responsible for failure. Measuring Effectiveness Even more difficult than measuring the efficacy of the vehicle and spermicide as separate components is the During the first stage of testing, the manufacturer usually attempt to measure the efficacy of the composite product in undertakes in vitro tests for spermicidal potency, toxicity, actual use. With coitus-dependent contraceptives such as local reactions, and possible carcinogenic properties. These the condom, diaphragm, and vaginal chemical prepara are followed by comparable tests in animals, usually rab tions, consistent use in each and every act of intercourse bits, since, in its sensitivity to spermicides, the rabbit is more important than any other factor. Therefore, a dis vagina has proved more like the human vagina than those tinction is sometimes made between theoretical (or physio of other laboratory animals (46,152). After the spermi logica I) effectiveness and use-effectiveness. Theoretical cide and base are combined, further tests measure the time effectiveness measures the intrinsic capability of a specific required for dissolution, foaming, and product dispersal. contraceptive, when used correctly without human error or Only then are clinical trials initiated, both with and without negligence, to prevent conception. Rates of theoretical sexual activity. effectiveness measure only "method failures" and are based on Iy upon pregnancies which occurred during regular To measure in vitro the potency of the spermicidal ingredi ents,various special tests have been devised. Baker in the 1930s developed one of the earliest tests, involving 48 dif ferent operations (7,8). Other variations were developed by Brown and Gamble (20,59,60,61,62), Sander and Table 3-Comparison of Product Contraceptive Cramer (137), Millman (111), Davidson (36), Carruthers Effectiveness by Point Scoring Method* (24), and Harris (73). Many of these are now incorporated Commercial 1st 2nd 3rd in the International Planned Parenthood Federation Total Contraceptive Insemi- Insemi- Insemi- Agreed Test for Total Spermicidal Power (90,130). The Points Product nation nation nation IPPF test approves preparations if 1.0 ml of a 1 :11 solu tion immobilizes all sperm in 0.2 ml of semen within 40 Delfen Cream 180 180 148 508 seconds after the semen and spermicide are mixed. Each Emko Foam 180 180 130 490 product must pass the test three times using semen from Lanesta Gel 170 180 130 480 three different donors or five times uSing semen from six Lactikol Creme 176 144 100 420 different donors (90,130). Lactikol Jelly 168 162 61 391 Durafoam Tablets 159 72 3 234 There is considerable question, however, whether spermi Lorophyn cidal potency measured in vitro has any relationship to the Suppositories 164 56 2 222 clinical effectiveness of the preparation (2,102). Studies Perfect by Johnson and Masters, for example, suggest that the dis performance score 180 180 180 540 tribution and mechanical function of vaginal contracep 'One point is allotted for each vaginal specimen showing all tives can alter spermicidal potency. After observing simu sperm immobilized; six specimens were taken from each of lated coitus photographed intravaginally, they concluded 30 subjects after each insemination. that the manner in which the base material spreads in the SOURCE : Johnson and Masters (87) .
H-44 Table 4-Effectiveness of Vaginal Chemical Contraceptives in Selected Major Studies Published Since 1960a
Failure Rates Refar Average (Pregnancies per Characteristics Number Woman- ance Brand 01 Location Duration Number of 100 Woman-Y earsl Author and Date of Population 01 Months N'um Preparation 01 Study 01 Use Pregnancies Studied Women 01 Use Method ber (in Monthsl Method and User Failure Failure JELLIES Margolis, Cavanaugh, 104 Lan.sta-Gel USA Young clinic patients 259 3,250 12 .5 21 N.A . 7.75 and Erns contacted monthly 1962 Kasabach 88 Koromex A USA Clinic patients 195 2,058 10.6 36 7.58 20.99 1962 Frank 54 Korome)( A USA Urban clinic patients; 684 6,594 9.6 127 N.A . 23.1 1962 3 mo. contact Tietze. Pai, T aylar, 162 Koromex. Puena Young, married, low 462 4,987 10.8 150 N.A. 36.09 IndGamble Lactikol, Rico income, rUfal; 1961 Lorophyn, 3 mo. contact Ortho-Gynol, and Precept in CREAMS Rovinsky 134 Dellen USA Medically indigent 251 2,915 11 .6 22 3.70 9.06 1964 clinic patients Tyler 164 Dellen USA Clinic patients, 508 6,783 13.3 35 .71 6.19 1965 (full dosel in mid-1950s Dellen Same as above 164 2,748 16.8 9 .44 3.93 (half dosel Combined sta tistics, 425 4,071 9.5 19 2.06 5.60 Dellen 6 investigators in 19505 (hall dosel SUPPOSITORIES God.ts 64 Syn-A-gen Belgium N.A . 56 1,344 24 2 N .A. 1.79 1973 FOAM TABLETS FuruSlwl et al 58 Neo Sampoon Japan Clinic patients, 124 1,058 8 .5 2 0 2.27 1968 Loop most aged 25-35 Ishihama .,d Inoue 82 Neo Sampoon Japan Farmers' wives, 587 8,955 15.3 24 0.67 3.22 1972 Loop most aged 25-35 Tyler 164 Dellen USA Combined statistics, 1590 11,096 7.0 133 4.22 14.38 1965 11 investigators in 1950s Dingle and Tietze 39 Durofoam USA "Poorly motivated" 240 1,749 7.3 32 N.A. 21.96 1963 clinic patients; 3 mo. contact Tietza, Pai, Taylor, 162 Fomos Puerto Young, low income, 166 1,565 9.4 50 N .A. 38.34 and Gamble Rico rural, married 1961 AEROSOL FOAMS Bushnell 21 Emko USA "Intelligent, 130 2,737 21 .1 4 0 1.75 1965 motivated" Carpenter .nd 23 Emko USA "Low motivated 1778 17,200 9.7 45 N.A. 3.14 Martin and disadvantaged"; 1970 3 mo. contact Bernstejn 14 Emko USA Mostly medically 2932 28,322 9.7 94 3.05 3.98 1971 indigent; 3 mo. contact
Kleppinger 91 Dellen USA Clinic patients; 138 1,116 8.1 7 2.15 7.53 1965 3 mo. contact
b Tietze and Lewit 160 Emko USA Hospital and 779 5,572 7.1 N .A. N.A. 28.3 1967 clin ic patients; ' -3 mo. contact Paniagua. Vaillant. 127 Emko Puerto Low income, 142 1,723 12.1 42 N.A. 29.25 end Gambia Rico urban, Catholic, 1961 married; contact each mo. SOLUBLE FILM 128 C·lilm Europe N .A . 716 5,194 7.3 23 N.A . 5.31 Pariser Egypt N.A. 91 1,638 18.0 10 N .A . 7.33 1974 N.A. = not available. aAlthough many studies of vaginal chemical contraceptives were conducted before 1960, changes of ingredients in some brands make the results of some early studies inapplicable to the products as now formulated. bAfter one year, as calculated by life table method. All other rates are calculated by the Pearl Formula.
HA5 contraceptive practice. Since the rates attributed to method Neo Sampoon Loop foam tablets, which are manufactured failure in existing studies range from .4 (164) to 7.6 (88) in Japan, resulted in pregnancy rates as low as 3.2 in a per 100 woman-years, the theoretical effectiveness of recently reported study including 587 Japanese farmers' vaginal co ntraceptives would appear to be fairly high (see wives (82). Other studies utilizing foam tablets, however, Table 4). have reported failure rates as high as 38.3 per 100 woman years (see Table 4).
Use-effectiveness measures what actually happens in prac tice, that is, w hen careless or inconsistent use are con sidered together with "method failure." It is a more valid A multi-center study of C-film, sti ll unpublished. reported measure tha n theoretical effectiveness. Use-effectiveness an overall pregnancy rate of 5.3 per 100 woman-years after rates were originally calculated by the Pearl formula- the 5194 woman-months of use (128). On the other hand, number of pregnancies per 1 00 woman-years of exposure C-f ilm failed a test by the British Family Planning Associa and thus may be biased either by the relatively high failure tion because nine pregnancies occurred among 45 women rates of short-time users or by the relatively low fa il ure du ring 175 cycles, for a pregnancy rate of 62 per 100 rates of long-time users. A more sophisticated method, life woman years. This is about the same as the rate which table analysis, which measures discontinuation rates over a mig ht be expected among women who use no contracep specified length of time (extended use-effectiveness), is tion. Users found that the quick-dissolving film tended to coming into wider use . adhere to sticky fingers and was therefore difficultto in sert (1 ,148).
Cli nica l trials sh ow a great variation in the effectiveness rates of vaginal contraceptives. These trials have taken It has long been known that use-effectiveness is related to place over a 40-year time period, using different types of experience with the method and to the stage of family vag inal contraceptives, different test populations, and dif formation in w hich the couple find themselves. A recent US ferent procedures for record keeping and follow-up (11. study by Professor Norman Ryder of Princeton based on 41 , 42, 44, 45, 50-53, 63, 65-67, 74, 75, 92, 129, 139. survey data has provided further insight into the reasons 155, 159, 163. 171. 174, 178, 179). Furthermore. studies of for contraceptive failure. Regardless of the specific method use- effectiveness were sometimes biased when irregular used, contraceptors who w ere trying to prevent further users or those w ho discon ti nued the method were excluded pregnanCies entirely were much more successful than con from the final calculations. Therefore, most of the re sults traceptors tryi ng merely to delay or space pregnancies. Of are not comparable w ith one another and certainly do not those using foams to prevent births, 22 percent experi provide conclusive evidence of the efficacy of vaginal enced an unw anted pregnancy compared with 36 percent methods or of one brand formulation as against another of those seeking merely to delay birth s. But in the entire brand . study 31 percent of those w ho used foams experienced un intended pregnancies, compared with 6 percent of those using pi lls, 8 percent using IUDs, 17 percent using con Nevertheless. some points do emerge from recent, larger doms, 23 percent using diaphragms, 33 percent using studies, w hich are summarized in Table 4. (Also see refs_ rhythm, and 45 percent using a douche (135) (see Fig. 1). no. 10,26.55,103,108,109,1 16,122,124,140.150.) Preg nancy rates range from about two per 100 woman-years in several relatively small clinica l studies to a high of nearly 40. Th e largest number of consistently low failure rates Over the last decade, va ginal contraceptives have (less than five per 100 years of exposure) are reported in been criticized or more often si mply ignored by those rece nt research with Emko and Delfen fo ams in developed in the fa mily planning field because of the high failure areas-either among private patients, or those attending rates. On the one hand, many experts believe that theo Pla nned Parenthood cli nics who se lected foams volun retical and use -effect iveness should not be differentiated, tarily, or in other programs w ith continuing follow-up. In that is, all failures should be conside red method failures several US studies, for example. women were introduced to since intermittent use of a contraceptive method actually the product by family planning outreach w orkers of similar reflects dissatisfaction with it (70,99,157). ethnic and social backgrounds who communicated to potential users their own confidence in the product (14, 21, 23,91 ,1 27, 164). On the other hand, some experts argue that those who choose vaginal methods toda y instead of more effective co ntraceptives may have ambivalent vi ews about pre Tw o studies, however, contradict the low rates other re venting pregnancy. Therefore they may unconsciously sea rch ers have found with foams. Tietze and Lewit reported choose and use a method carelessly, with resulting high a pregnancy rate of 28.3 after 12 months for 779 US pregnancy rates. Although contraceptive effectiveness is w omen using Emko foam. This ra te, calculated by the life very important in some circumstances, in other cases, for table method, is lower than the pregnancy rate in the same example w here abortion is readily available, different fac study for women who used jellies or crea ms alone (36.8) tors may w eig h more heavily in a couple's choice. Even if but hi gher than that of women w ho used diaphragms with relatively ineffective, a method which is easy to secure jelly (17.9) (160). In a Puerto Ri ca n study, Paniagua and use may double or triple the interval between births et 81 reported a failure rate w ith Emko foam of almost 30 and thus meet individual or comm unity needs more per 100 woman-years (127) (see Table 4). These rates are readily than a highly effective, sophisticated method high in comparison to oral contraceptive or IUD preg which requires the supervision of trained medical per nancy rates. sonnel (136) .
H-46 Moreover, for t he infrequent user or for women w ho need fou nd that use of foa m had increased from 3.3 percent in temporary protection after IUD removal or omission of 1965 to 6.1 percent in 1970. By comparison, in 1973 several pills or for women who prefer not to use orals or about 10 million women in the US used oral contraceptives IUDs, vaginal contraceptives, especially foam, provide a (131 ) and three to four million, IUDs (97,166). reasonable alternative comparable to condoms. Although not as effective as condoms, they do not require th~same degree of mal e cooperation as do condoms, nor do they One point is cl ear. The use of vaginal contraceptives has diminish penile se nsi tivity as condoms are sometimes declined substantial ly since oral contraceptives and IUDs alleged to do. were introduced in the early 1960s. In 1969 in Japan, where abortions were readily available and orals and IUDs w ere not legal, about 9 percent of married women of repro ductive age used jellies or foa m tablets (1 23). Elsewhere, .. use of vaginal contraception in recent years probably has not exceeded 5 or 10 percent of the population of repro \ USE AND DISTRIBUTION ductive age. In Melbourne, Australia, a retrospective survey of once-married women under 60 living w ith their husbands showed that the use of spermicides as the main The International Pl anned Parenthood Directory of Con method of fa m ily planning declined from 20 percent in the traceptive s (71) lists co ntraceptives marketed throughout 1930s and 1940s to 2 to 3 percent in the late 1960s. the world, incl uding brand names, manufacturers, and dis From 1965 on, over 30 pe rcent of these Melbournewomen tributors of vaginal contraceptives. These include 65 were using orals (22). In Europe, a 1971 survey of family products in tubes (creams, jellies, or pastes), 35 supposi planning attitudes and practices indicated that only 1 per tories, 33 foam tablets, and six pressurized foams. Al cent of the married w omen in Great Britain w ere then using though aerosol foams are probably the most effective of vaginal ch emical methods and even few er in Italy, Bel these, no more than five f irms manufacture them beca use gium, France, and West Germany (81). About 5 percent of the large investment in equipment that is necessary. In in Britain were using spermicides together with dia the USA and Britain the number of vagi nal products on phragms or condoms (18). the market has declined steadily since the 1950s, with only about one third as many products listed in 1971 as two decades before (72). Promotion and Sales Assessing the actual use and distribution ofthese products Before the 1960s, the major US manufacturers con cen is difficult (68). Si nce prescriptions are not required, trated their sales effort on persuading phYSi cians to recom women who select these methods are not likely to seek mend specific vagi na I contraceptives for use together the advice of physicians, and, in t urn, phYSi cians and with diaphragms fitted by phYSicians. Thus the most effec family pla nning programs do not generally recommend or tive vaginal preparati ons were not promoted directly to dispense vaginal co ntraceptives unless orals, IUDs, or the consumer market, but indirectly through the medical steri lization are co ntraindicated. On the w hole, use of profeSSi on. vaginal methods is far less than that of orals, IUDs, sterilization, or condoms, which have replaced vaginal methods in most developed countries. Use of ae rosol foams More recently, as t he diap hragm has been replaced by and foam tablets, however, is increasing as compared to other methods and as public discussion of family pla nning jellies and creams, and it may increase further in many has made direct advertising and pharmacy display of non co untries if these products are more read ily available and prescription contraceptives more acceptable, some manu more vigorously promoted. facturers have undertaken more vigorous promot ion and distribution of va ginal contraceptives. In the USA, for exa mple, the Emko Company, which produces no co ntra An International Pl an ned Parenthood Federation survey ceptives except foam, has taken the lead in public adver estimated that 1,041 ,500,000 doses of spermicides were tising, and now supplies 40 percent of the domestic foam distributed in 1971 in t he 73 cou ntries w here IPPF affili market. The Ortho Pharmaceutical Corporation, on the ates were able to provide informat ion (78). Two-thirds of these were in Western Europe . If 100 doses provide one year's protection for the average couple (177), the IPPF figure could mean that about 10.4 million w omen in those 73 countries were regular users of va ginal contraceptives. However, the use of vaginal contraceptives is often The International Planned Parenthood Federation irregular, and probably many more women use them, will provide upon request a full description of the though not regularly. Agreed Test of Spermicidal Power and a list of products which have passed the test. The IPPF Estimates vary about the use of vaginal contraceptives in Directory of Contraceptives (1971) is also avail the USA and other developed countries. According to one able. Contact: drug manufacturer's estimate about four million US w omen The Medical Department now use them (112). Another manufacturer has estimated International Planned Parenthood Federation there are more than two million current US use rs of foam 18-20 Lower Regent Street (142). The 1970 US National Fertility Study placed the London SW1 Y 4PW number of US users of contraceptive foam at about 1.5 United Kingdom million in that year (135) . The study, based on a survey of over 5000 couples in which the wife was under 45,
H-47 other hand, which manufactures and distributes all types ceptives. India, Korea, Sri Lanka, Jamaica, and Kenya of vaginal and oral contraceptives as well as many other have permitted advertisements for condoms, but so far medical supplies, promotes its products primarily to phy vaginal preparations have not been promoted in the same sicians. During 1973, Ortho produced about 55 percent of way. the foam products sold in US pharmacies as well as about 80 percent of the jellies and creams (80). Sales of vaginal contraceptives are generally permitted through any retail outlet, although some US states and a In recent years vaginal contraceptives, particularly aerosol few countries attempt to limit distribution to registered foam and cream products, have been advertised in women's pharmacies. In certain European countries, such as Ger magazines and in some general interest magazines. In order many, Sweden, Denmark, and the United Kingdom, vaginal not to offend public sensitivities, however, most advertise contraceptives can be purchased in specialty shops which ments describe the product in such vague terms that the sell products associated with sex. Mail order sales are message may not be conveyed clearly to the consumer. important in Germany and in some other countries. Moreover, some douches and other vaginal products are similarly advertised in such ambiguous terms that con Sales in Developing Countries sumers may think these products also have contraceptive Several studies of contraceptive distribution through value, even though they do not. In the USA many state the commercial sector have been made in developing coun laws prohibit contraceptive advertisements. US television tries. In nine country surveys the Westi nghouse Popu lation accepts advertisements for vaginal sprays and vaginal Center interviewed fertile urban couples who had cash douches which are used for cosmetic purposes but does not incomes. In Turkey, Pakistan, and Panama, users of foams/ accept advertisements for vaginal contraceptives. creams or other products amounted to 4 percent of those interviewed. For Jamaica, the figure was 2 percent. Except There are fewer restrictions on contraceptive advertising in Pakistan, these users were all supplied through com in Europe and Japan, where advertisements appear in both mercial channels. In Iran, Korea, the Philippines, Thailand, newspapers and magazines, but not on television. In and Venezuela, vaginal products were rarely used (172, Sweden, foam is advertised widely, even at cinema per 173). formances. A somewhat similar survey by Arthur D. Little Inc. (5) Most developing countries accept family planning adver noted that vaginal contraceptives constituted "a minor tisements which do not mention specific types of contra volume of all contraceptives sold through commercial
Table 5-Retail Prices of Selected Vaginal Contraceptive Products in Selected Countries, 1974
Approximate Retail Number of Product Name Price in uS$ Country of Sale Annual Sales or Number of Users Applications (as of June 1974) Emko Foam $4.00 30 UK, F inland, South Africa 1 million users, USA & Canada $2.89 - $3.25 30 USA, Canada 20,000 users, UK 40,000 users, Finland
Gynomin foam tablets $ .75 12 UK $50,000 (US), UK $1.10 12 South Africa 42,200 tubes, South Africa
Duragel $ .37 + taxes 56 UK $14,100 (US), UK
Conceptrol cream $2.63 10 UK
Conceptrol cream premeasured $2.51 6 USA
Neo Sampoon Loop tablets $2.11 20 Philippines 1,000,000 tubes, Japan 1.72 20 Thailand 530,000 tubes, Asia 1.10 20 Hong Kong 55,000 tubes, Africa and 1.48 20 Singapore Middle East 1.20 20 South Vietnam 1.95 20 Guatemala 1.80 20 EI Salvador 90,000 tubes, Latin America 2.40 20 Dominican Republic 1.90 20 Panama
Peoples Republic Tablets $ .05 12 Peoples Republic of China N.A.
Syn-A-gen/A-gen 53 $1.85 - $2.72 6 Europe (5 countries) 5 million suppositories suppositories Africa (5 countries) Asia (11 cou ntries) Central America (10 countries) South America (2 cou ntries)
SOURCE: Data from manufacturers. Data on Peoples Republic Tablets from Ohneda (120).
H-48 channels" in Colombia, Iran, and the Philippines. "The Table 7-New Acceptors of Vaginal Products in 11 reasons for the sma II vol ume," accordi ng to the study, were Government and/or Family Planning Association " lack of consumer demand, restriction on distribution to Programs, 1971 the drug network, and lack of product availability. The authors do not believe that drug firms are likely to in Acceptors of New Vaginal crease their efforts to promote these products because Total New Acceptors Preparations Country of lack of potential consumer demand for them" (5). Acceptors of Vaginal as Percent of Preparations Total Promotion, however, appears to increase consumer Acceptors demand. In 1972 a four-month pilot project that provided Bangladesh 127,051 54,389 43 pamphlets for pharmacists in Colombia to distribute with Barbados 3,265 1,081 33 information on orals, condoms, and suppositories produced Pakistan 329,245 73,306 22 a 63 percent increase in suppository sales, an 81 percent Ghana 27,217 4,635 17 increase in condom sales, and a 26 percent increase in Sierra Leone 701 99 14 Jamaica 26,632 2,479 9 orals sales. Even in drugstores which did not distribute the Puerto Rico 44,660 4,033 9 pamphlets, suppository sales increased by 39 percent (6). USA 1,263,837 93,375 7 St. Lucia 2,390 146 6 Ecuador 13,722 670 5 An analysis of contraceptive distribution in Nigeria, Ghana, German Federal Kenya, and Uganda during 1970 showed sales of 288,000 RepUblic 2,100 97 5 vaginal foam tablets in Nigeria and 204,000 in Ghana, with SOU RCE : Huber (78). smaller amounts sold in Uganda and Kenya. There were some tube cream sales in all four countries (16). Since sup positories have been used traditionally by the Yorubas in Nigeria as abortifacients and since in the minds of some men vaginal methods are less likely than pills or IUDs to Costs encourage women to be unfaithful (125), a still larger market may exist in Africa for these products. Retail prices vary considerably according to the type of vaginal product and the type of distribution outlet. In Black noted that, "In West Africa, in particular, 'chemical general, aerosol foams and premeasured doses of cream are sellers: or patent medicine dealers, felt this market was the most expensive, tubes of cream are in the middle range, being held back by inadequate importation of products and jellies and foam tablets are the least expensive. Retail rather than by lack of demand." Manufacturers are "un costs per application range from about $.02 (US) to $.45 willing to make any significant promotional investments in (US) (see Table 5 for selected prices). AJapanese manufac view of the threat to the markets from the increasing flood turer has reported that foam tablets are sold in the Peoples of subsidized contraceptives, as supplied through bilateral Republic of China for the equivalent of about one-half cent aid and distributed by family planning organizations" (16). per tablet (120).
Such evidence, although far from conclusive, suggests that a market may exist for vaginal products, but that these Bulk costs paid by international donor agencies are, of products so far have not been vigorously promoted. Nor course, lower than retail prices, but in all instances the have the most effective formulations been the most widely costs of vaginal contraceptives, like those of condoms, are marketed. increasing. In fiscal 1973 the US Agency for International Development (USAID) paid $.95 (US) for a 90 gram aerosol container of Emko with applicator. In 1974 the price was $1 .10 (US). Since 1.2 grams are required for protection, Table 6-Deliveries of Vaginal Chemical the per application cost is approximately one and one-half Contraceptives Financed by US Agency for US cents. The cost to USAID for 50 grams of Delfen foam International Development, by Fiscal Year and with applicator is $1 .30 (US). With slightly less than one Continent, 1971-1974 1 gram needed for protection, the per application cost is approximately two US cents. UNICEF has recently pur 1971 1972 1973 1974 chased Neo Sampoon Loop foam tablets at about $.65 (US) Latin America2 for 20 tablets, or about three US cents for each applica Foam 58,945 64,684 49,983 47,931 tion (121). These prices should be compared with the cur Jelly 27,580 72,232 90,120 41,912 rent cost to USAID of approximately three US cents for a Asia Foam 10,153 4,394 4,664 406,975 single condom (114) and approximately $.13 for a month's Jelly 10,092 34,368 35,976 42,120 supply of oral contraceptives (38) when purchased in Africa quantity. Foam 119,260 127,794 100,470 40,258 Jelly 14,580 14,076 11,988 8,496 TOTAL I Foam 188,358 196,872 155,117 495,164 USAID Shipments Jelly 52,252 120,676 138,084 92,528 At present the distribution of vaginal contraceptives lAlso, 4000 containers of vaginal tablets delivered to Africa in through family planning programs is not substantial. 1974. Foams in number of 90 gram units or equivalent; jellies in number of tubes. USAID, which is the principal source of subsidized contra 21 ncludes Caribbean. ceptive supplies, has not stressed vaginal contraceptives in SOURCE : US Agency for I nternational Development, Com its bulk purchasing because of a deliberate program deci modity Reports System, December 1974. sion to give first priority to the most effective methods.
H-49 For example, between fiscal years 1971 and 1974, family planning aSSoCiations, IPPF supplied 16 times as USAID supplied about one million 90·gram units or the many foam tablets in 1974 as in 1971 (see Table 8 ). This eq uivalent of aerosol foams, approximately half of that increase is caused in part by requests from new programs in 1974 (see Table 6). USAID supplied about 400,000 in the Philippines and in Indonesia, but it may also be the tubes of jelly over the same four-year period. result of vigorous promotion by the Ei sai Company of Japan of the new Neo Sa mpoon Loop foam tablets. To supply these requests, the IPPF purch ases contra ceptives Until 1974, the largest shipments of foam were consigned directly from the manufacturers as w ell as obtaining them to Africa, w he re shortages of medical personnel may have from USAID. delayed the spread of IUDs and oral contraceptives, bu t in 1974 shipments to Asia increased a hundredfold. About 300,000 units were sent to Ba ngladesh for its new family Si nce most family planning administrators have notempha planning program. Pakistan, which stepped up its pro sized the use of vag inal contraceptives, the present level gram, rece ived about 100,000 units. of dema nd for these products, although not high, probably reflects the continuing preference of some individuals and a few family planning clinics. Th e growing interest in non Program Distribution cl inical distribution by midwives, retail outlets, bazaars, The International Planned Parenthood Federation (lPPF) pedd lers, and the like- although so fa r focused primarily has gathered data on the choi ce of vaginal aerosol foam, on condoms and pills- may eventually contribu te to wider foam tablets, jell ies, and creams by patients In cli nics and use of self-ad ministered vag inal contraceptive methods. other family plann ing program facilities (78). An extensive study based on detailed questionnaires from 98 countries re vealed that in 1971 there were either no new acceptors or an unknown number of acceptors of va ginal methods re VENEREAL DISEASE PROPHYLAXIS ported in 65 country programs. These figures, of course, may be attributable to program decisions and to the non availability of va ginal preparations as well as to individual If cu rrent research is successfu I, vaginal contraceptives consumer choice. Of the 33 countries where government may be shown to offer an additiona l benefit as a VD pro and lor private fa mily planning programs did record new phylactic. Studi es now being carried out by Drs. Cu tler, acceptors of va ginal preparations, only 11 showed 5 per Singh, and associates at the University of Pi ttsburgh are ce nt or more accepting these methods (see Table 7). directed toward the identif ication of vaginal preparations with both contraceptive and prophylactic prope rti es (13, 17,30,31,32,33,34,95, 143, 144,145,146). IPPF -supported clinics have not experienced any great in crease in the use of jell ies, creams or aerosol foams since 1971. even though the use of ot her methods has grow n Initial in vitro tests have compared 20 products which are substantially. Foam tablets, on the other hand, have be now in use on the basi s of their effect on Neisseria gonor come more popular. In response to requests from local rhoeae and Treponema pa ll id um (syphilis). They were
Table a-Vaginal Chemical Contracept ives Provided by t he International Planned Parenthood Federation, by Calendar Year and Area, 1971·1974, and Scheduled Deliveries, 1975 (by number of containers)
Estimated To Be Used Used Used Product and Area Usage Delive red Total 1971 1972 1973 1974 1975 JELLI ES/CR EAMS a Africa 11 ,900 11,981 13,913 16,204 7,530 61,528 Asia 21 ,083 26,936 30,242 42,396 16,150 136,807 leItin America 13,432 20,048 26,856 32,020 41,984 134,340 and Caribbean TOTA L 46,415 58,965 71,011 90,620 65,664 332,675 FOAM TABLETS a Africa 4,208 17,265 20,751 23,856 58,000 124,080 Asia 3,931 19,341 114,606 286,820 53,300 477,998 leIti n America 12,913 1,689b 2,540 28,940 102,400 148,482 and Caribbean TO TAL 21,052 38,295 137,897 339,616 213,700 750,560 AEROSOL FOAMS Africa 17,336 15,014 11,490 13,9 46" 7,384 65,170 c Asia 17,661 12,311 54,639 51 ,600 18,850 155,061 Latin America 43,667 34,017 35,017 36,000 59,246 207,947 and Caribbean TOTAL 78,664 61,342 101,146 101,546 85,480 428,178
aexclud ing Tunisia bexcluding Trinidad and Tobago ce xcluding Philippines and Sabah SOURCE : Internatio nal Planned Parenthood Federation, Report to Donors, September 1972,1973, and 1974 (82,83,84).
H-50 Table 9- Lowest Concentration of 20 Contraceptives Requ ired to Inhibit the Growth of N. Gonorrhoeae by Two Methods3
Time-Exposure Method Plate-Dilution Method Concentration Growth after Concentration c d Contraceptive pH Exposure IMin .) pH Growth IParcent)b IPercent) 1 5 10 Cartane Vaginal Jelly 10 4.6 + -- 10 7.5 - Contra Creme 50 6.9 + ± - 10 7.5 - Co ntra Foam 10 7.5 ± -- 10 7.5 - Cooper Creme 1 6.7 --- 10 7.6 - Delfen Cream 20 5.2 + + + 10 7.6 - Delfan Foam 50 4.9 --- 20 7.6 - Em ko Concentrate 50 7.4 --- 20 7.5 - Em ko Concent rate +A 50 7.1 -- - 20 7.2 - Emko Concentrate +8 50 7.2 - - - 20 7.2 - Emko Co ncent rate + Spermicide 20 7.0 + + - 20 7.3 - Emko Foam 10 7.3 - - - 10 7.4 - Im molin Vaginal 50 4.9 --- 10 7.5 - Koromex A Vaginal Jelly 10 6.0 + -- 50 7.5 - Lanesta Gel 10 5.6 + - - 10 7.5 - Lorophyn Suppositories 10 5.7 + -- 10 7.5 - Miiex Crescent 10 5.7 --- 10 7.5 - Ortho Creme 1 6.2 + -- 1 7.4 - Orthogynol Jelly 10 5.5 + - - 10 7.4 - Preceptin Gel 1 5.6 -- - 1 7.4 - Ramslls Vaginal 50 6.7 + + - 50 7.5 -
aBacterial suspension for these experiments contained about 106 CFU per 0.1 ml, the inoculated Thayer-Martin selective medium plates were incubated at 37°C. in CO 2 incubator. bOnly 50,20, 10, and 1 percent dilutions in physiological saline solution were tested. cpH of media after adding the contraceptive at different concentrations. dResults from duplicate plates. SOURCE: Singh, Cutler, and Utidjian (145).
analyzed according to the length of time required to kill A vaginal preparation which offers both contraception the VD organisms and the minimum concentration that was and VD prophylaxis might be a major step in preventing effective against them. the spread of VD. Such an agent would be the first female contraceptive method to offer the kind of dual protection, even to a limited degree, against both venereal disease In 1-,5-, and 1 O-minute time exposure tests three contra and pregnancy which has long been provided by the ceptives-Cooper Creme, Ortho Creme, and Preceptin Gel condom (35). at a 1 percent dilution inhibited the growth of N. gonor rhoeae bacteria. Eight of the contraceptives were effective at 10 percent concentration. In a plate-dilution test, Ortho Creme and Preceptin Gel were effective at a 1 percent Table 10-Dilutions of Contraceptives Required concentration, and eleven others, at a 10 percent concen to Immobilize T. Pallidum Suspension tration (see Table 9) (145). within 1 to 1.5 Minutes
Concentration Number of In tests of the effectiveness of various vaginal contracep Name of Contraceptive Ipercent) Contraceptives tive products against syphilis, an Emko concentrate and Ortho Creme at a 1 percent concentration immobilized T. Emko Concentrate +8, 1 2 Ortho Cream pallidum, the spirochete responsible for syphilis, within 1 to 1.5 minutes; 12 preparations were effective at a 10 per Certane Vaginal Jelly, Contra 10 12 Foam, Cooper Creme, cent concentration, three at 20 percent, and two at 50 per Delfen Cream, Delfen cent (see Table 10) (145). Foam, Emko Concen trate, Emko Concentrate +A, Finesse, Immolin Preliminary results of these tests have been encouraging Vaginal Cream-Jel, and further in vitro and in vivo tests are planned. Progress Lorophyn Suppositories, in this area is especially important for several reasons: Orthogynol Jelly, Preceptin Gel public health measures have had limited success in con trolling the spread of venereal disease (147,175); gonor Contra Creme, Lanesta Gel, 20 3 Ramses Vaginal Jelly rhea is becoming more resistant to penicillin therapy (101,147,153,154); syphilis, although not resistant to Koromex A Vaginal Jelly, 50 2 Milex, Crescent Jelly penicillin, is infecting more and more people, an in creasing proportion of whom react advetsely to the drug. SOURCE: Singh, Cutler, and Utidjian 1145). H-51 23. CARPENTER, G. and MARTIN, J. B. Clinical evaluation of a BIBLIOGRAPHY vaginal contraceptive foam. In: Sobrero, A J. and McKee, C., eds. Advances in planned parenthood. Vol. 5. Proceedings of the Seventh Annual Meeting of the American Association of Planned Parenthood Physicians, San Francisco, California, April 9-10, 1. ANONYMOUS. C-film: a new spermicidal contraceptive. Drug 1969. 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H-54 136. SANDBERG. E. C. and JACOBS. R. I. Psychology of the mis 160. TIETZE. C. and LEWIT, S. Comparison of three contraceptive use and rejection of contraception. Medical Aspects of Human methods: diaphragm with jelly or cream. vaginal foam. and jelly/ Sexuality 6(6): 34-70. June 1972. cream alone. Journal of Sex Research 3(4): 295-311 . November 1967. 137. SANDER. F. V. and CRAMER. S. D. A practical method for testing the spermicidal action of chemical contraceptives. Human 161 . TIETZE , C. Relative effectiveness. In: Calderone, M . S., ed. Fertility 6(5): 134-137. October 1941. Manual of family planning and contraceptive practice. 2nd ed. Baltimore, Williams & Wilkins Company, 1970. p. 268-274. 138. SANHUEZA. H. Personal communication. April 23. 1974. 162. TIETZE, C.• PAL D. N.• TAYLOR, C. E. • and GAMBLE. C. J. 139. SEIBELS. R. E. The effectiveness of a simple contraceptive A family planning service in rural Puerto Rico. American Journal method. Human Fertility 9(2): 43-47. 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Conception control: a clinical October-December 1968. evaluation of the Preceptin-Gel method. American Journal of Obstetrics and Gynecology 72(3): 549-556. September 1956. 158. THOMAS, H. H. Vaginal contraception-a necessity. Pacific Medicine and Surgery 73: 74-78. February 1965. 180. ZUSPAN, F. P. • BIBBO, M .• GARDNER, H. L.. HESSELTINE. 159. TIETZE, C. The clinical effectiveness of contraceptive meth H. C., KEETIEL, W . C. • LANG. W. R., and WElD. G. L. Management ods. American Journal of Obstetrics and Gynecology 78(3): 650 of patients with vaginal infections: an invitational symposium. 656. September 1959. Journal of Reproductive Medicine 9(1): 1-16. July 1972. GWU-SCD-75-01 P H-55 Publications of the Population Information Program Department of Medical and Public Affairs The George Washington University Medical Center 2001 S Street. N. W .• Washington. D. C. 20009 U. S. A.
ORAL CONTRACEPTIVES Series A A-l, Oral Contraceptives-Fifty Million Users
INTRAUTERINE DEVICES Series B B-1, Copper IUDs-Performance to Date
STERILIZATION Series C Female C-l, Laparoscopic Sterilization- A New Technique C-2, Laparoscopic Sterlization II; What Are The Problems? C-3, Colpotomy-The Vaginal Approach C-4, Laparoscopic Sterilization with Clips C-5, Female Sterilization by Mini-Laparotomy
Series D Male D- l , Vasectomy-Old and New Techniques D-2. Vasectomy-What Are The Problems?
LAW AND POLICY Series E E- l, Eighteen Months of Legal Change E-2, World Plan of Action and Health Strategy Approved
PREGNANCY TERMINATION Series F F-l, Five Largest Countries Allow Legal Abortion on Broad Grounds F-2 , M enstrual Regulation- What Is It? F-3. Uterine Aspiration Techniques F-4 , Menstrual Regulation Update
PROSTAGLANDINS Series G G-l , Clinical Use of PGs in Fertility Control G-2, Fertility Control Research Maps and Directory G-3, A Review: Modulation of Autonomic Transmission by Prostaglandins G-4, "Prostaglandin Impact" for Menstrual Induc tion G-5, Physiology and Pharmacology of PGs in Parturition
BARRIER METHODS Series H H-l , Condom- An Old Method Meets a New Social Need H-2, The Modern Condom-A Quality Product for Effective Contraception H-3, Vaginal Contraceptives - Reappraisal
PERIODIC ABSTINENCE Series I 1- 1, Birth Control Without Contraceptives
FAMILY PLANNING PROGRAMS Series J J-1, Family Planning Programs and Fertility Patterns J -2, World Fertility Trends, 1974 J-3, Advanced Training in Fertility Management
INDEX 1972-1973
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