SPECIAL REPORT

Evidence for the Acceptability of an Injectable Hormonal Method for Men By Karin Ringheim

he search for a safe, effective and re- relationships received weekly injections of the century.5 No studies have examined versible hormonal method of fertil- of 200 mg of enanthate. Those the important question of whether the Tity regulation for men has been un- who became azoospermic (65%) continued method will find acceptors, but the atti- derway for more than 20 years. Several with weekly injections for a period of 12 tudes and opinions of men who partici- publicly supported and international bio- months, during which the contraceptive pated in the clinical trials may provide medical research organizations, including efficacy of the method was assessed. Azoo- helpful insights. the World Health Organization (WHO), spermia was associated with near perfect This report presents information as the Population Council, the Contraceptive contraceptive efficacy (just 0.8 conceptions gleaned from focus group discussions and Research and Development Program, per 100 person years).2 questionnaires completed by men who vol- Family Health International and the Na- A second study investigated whether unteered for the trials. The shortcomings tional Institutes of Health, have conduct- this state of complete azoospermia was nec- of the present formulation and the plans to ed or supported research in this area in de- essary for contraceptive efficacy. Between address them are important to keep in mind veloped and developing countries. As a 1990 and 1994, 15 centers in nine countries when assessing the observations of the early result, a variety of hormonal compounds participated in a study in which men also clinical trial participants. Nonetheless, the and contraceptive delivery systems, in- received weekly injections of 200 mg of findings add to an extremely limited body cluding injections, pills, implants and , but the 12-month of evidence indicating that there may be a patches, are currently under investigation. contraceptive efficacy assessment stage niche among contraceptive users for a hor- Many factors, however, including lim- was initiated sooner—when men reached monal method for men. ited funding and a lack of commercial in- a state of oligozoospermia (less than three terest in male fertility regulation, have million sperm/ml). The vast majority (97%) Information Sources slowed progress. Pharmaceutical compa- of the 289 men who remained in the study Focus group discussions, which are struc- nies reportedly doubt that a market exists for six months achieved this level of sub- tured by a relatively strict set of guidelines for hormonal contraceptives for men and fertility, and their subsequent experience and procedures, are useful for gathering in- fear the potential for litigation.1 demonstrated that complete azoospermia formation about values and beliefs and for Nonetheless, clinical trials of a hormonal was unnecessary to achieve an acceptable gaining a better understanding of prefer- method, supported by WHO, have shown contraceptive efficacy.3 ences and motivation.6 Six of the oligo- encouraging results. Between 1986 and While testosterone enanthate has been zoospermia clinical trial centers were in- 1990, 10 centers in seven countries com- valuable in establishing the viability of a vited to conduct focus groups, and four pleted a clinical trial demonstrating the hormonal agent for male contraception, it centers agreed—Sydney, Bangkok, Singa- contraceptive efficacy of azoospermia (or has several drawbacks, including the need pore and Edinburgh. All men who had par- the absence of sperm) induced by testos- for frequent injections and for a relatively ticipated in the clinical trials—an average terone enanthate, a drug long used to treat long period (3–4 months, on average) to of 10–20 per center—were invited to attend. hypogonadal men. In that trial, 271 healthy achieve oligozoospermia; it also has a Because these focus groups were held at a fertile men aged 21–45 who were in stable pharmacokinetic profile that produces minimum of several months after the trial above-normal testosterone levels imme- ended, many of the original participants Karin Ringheim is a Senior University of Michigan In- diately following each . Thus, in were no longer near the center. The 23 men ternational Population Fellow in the Research Division of the Office of Population, United States Agency for In- future trials testosterone enanthate will be who did attend the discussions—approx- ternational Development (USAID), Washington, D.C. At combined with another hormone (such as imately 5–6 from each center—were those the time this report was written, she was a scientist with DMPA), to shorten the time needed to who were available and interested. the Task Force for Social Science Research on Repro- achieve a contraceptive effect, or a new for- The focus group discussion guide in- ductive Health, World Health Organization (WHO), Geneva. This article is based on a report to the Task Force mulation (such as testosterone buciclate, cluded as topics the participants’ contra- on Methods for the Regulation of Male Fertility of WHO’s which requires less frequent injections and ceptive histories, communication with Special Programme on Research, Development and Re- does not produce a physiological peak4) their partner, and decision-making pat- search Training in Human Reproduction. Analysis of the will be used. terns. A primary interest was to gain the data was supported by the Office of Population, USAID. The author would like to thank G. M. H. Waites and Researchers believe that with a full-scale perspective of these “experts” to help de- David Griffin of WHO, the leaders of the focus groups effort, a newly-formulated product could velop acceptability studies for future clin- and the men who participated in the clinical trials. be ready for introductory trials by the turn ical trials of methods for men. Content

Volume 21, Number 2, June 1995 75 Acceptability of a Hormonal Method for Men analysis, the key to the full utilization of be constantly attending to contraceptive focus group transcripts, was hampered to Table 1. Percentage and number of respon- options, mindful of the need to be diligent, dents in a 1990–1994 multicountry study of a some extent by variations in moderators male injectable contraceptive, by responses and acutely aware of, and disappointed by, adhering to the discussion guide. to items on a follow-up questionnaire the limited range of choices. The contra- Questionnaires completed by partici- ceptive histories of focus group partici- pants 12 months after completion of the Item % No. pants revealed a wide experimentation oligozoospermia trial as part of the on- Main reason for participation with methods, and subsequent difficulties Needed a change in going follow-up examination are anoth- contraceptive method 36 55 or dissatisfactions with nearly all of them. er source of data. Thus far, 154 participants Partner or spouse encouraged me 23 35 The questionnaire respondents reported have responded—81 from China, 41 from Doctor encouraged me 23 36 having used an average of 2.4 methods each; Belief in male responsibility 6 9 Australia, 13 from the United Kingdom, Desire to try new things 5 8 the number is probably an underestimate, 13 from the United States, three from Sin- Interest/belief in male methods 3 4 since it is based on men’s recollection or gapore and three from Thailand. The Friend/relative encouraged me 3 4 knowledge of a partner’s use of methods. Interest in scientific research 1 2 questionnaires, which included multiple Money was important 1 1 The pill was the predominant method used choice items on what motivated the men All 100 154 by the partners of Australian, U.K. and U.S. to participate in the trials and on their con- How heard about study respondents, while the IUD was the meth- traceptive histories, also provided an op- Doctor 34 53 od most frequently used by the partners of portunity to write in comments, and a few Newspaper 23 35 the Chinese men. At the time of the study, Group dissemination* 15 23 of these remarks are quoted here. Friend 12 18 the contraceptive implant was virtually un- Television/radio 10 16 known by respondents outside of China, Motivation for Participation Spouse or partner 3 4 and only two questionnaire respondents Clinic/health professional 2 3 Sharing Responsibility Poster 1 2 said their partner had ever used an in- The investigators knew full well that a reg- All 100 154 jectable contraceptive. imen requiring weekly and often painful Methods used in past† Almost 80% of the men who respond- injections would be impractical and un- Condom 84 129 ed to a question on whether previous Pill 56 86 acceptable as a method of fertility regula- IUD 40 61 problems with a method had influenced tion. Therefore, an acceptability study of Diaphragm/cap/sponge 24 37 their participation in the study replied af- the method as it was delivered during the Rhythm 23 35 firmatively. While this finding reflects a Withdrawal 8 13 clinical trial would be premature. Bio- Implant 4 6 self-selection factor, it also points to the medical and social scientists were nonethe- Injection 1 2 need for advances in contraceptive de- less intrigued by what motivated men to velopment, including the refinement of ex- *Among the 81 Chinese participants only. †Multiple responses could join such a study. Were they representative be given. Note: The questionnaire was administered 12 months isting methods, such as the pill, that con- after completion of the latest trial in 1994; responses are still being of a societal fringe element? Were they sim- received, and the total number of respondents may increase. tinue to cause side effects. ply risk-takers? Or do-gooders? Men who completed the oligozoosper- Problems with the Pill mia follow-up questionnaire were asked wife or partner to join the study, that part- Nearly every focus group participant to identify the main reason they joined the ner frequently had a history of contracep- whose partner had used the pill men- study. As Table 1 shows, 36% reported that tive problems. In fact, the overwhelming tioned that she had had one or more of the they needed a change in their contracep- majority of questionnaire respondents in- following side effects—nausea, weight tive method, and 23% said that their dicated that “doing a good thing for my gain, depression, acne, liver spots, mood spouse or partner had encouraged their partner” by using a male method was a swings, painful periods, diminished li- participation. About 9% were interested “very important” motivational factor for bido, headaches, cramping and “feeling specifically in men’s responsibility in con- them. All but two of the 154 respondents unwell” in general. traceptive practice or believed in the im- indicated that this motivating factor was As a result, discussants often mentioned portance of developing a male method. A at least “somewhat important.” that they were anxious to relieve their few were motivated by a desire to try new The men’s motivation for participating in wives of the need to take the pill: things. One questionnaire respondent ex- the trial was explored in more depth in the “My wife taking estrogen was like the pressed a view that many seemed to share: focus groups. Because many men mentioned shrew that couldn’t be tamed. She would “[I am] always looking for contraception their contraceptive history as a couple, the wake up depressed…and after a period that is suitable for both of us.” motivation and contraceptive experience of time I said, ‘Honey, it’s the pill, stop tak- Participants learned about the study merged as themes in the discussions: ing it, I don’t care, I’ll use condoms, or through a variety of personal and media “My wife had been taking the pill for other forms of birth control, I’ll go on the contacts, as the table shows. More than nine years. I felt that she was helpless, so program that my friend is on, but you stop one-third of the men (34%) reported that why shouldn’t it be my turn?” taking the pill right now…’ “ their doctor had encouraged them to take “When she takes the pill and it does “I thought that I should be shouldering part in the study, including nearly half of something to her, I don’t feel good.” my share of the responsibility for contra- the participants from China. (More than These findings suggest that there may ception because she was having problems one-quarter of Chinese participants be a reservoir of men who are motivated with the pill.” learned about the study through “group less by a desire to control their own fer- One Thai participant appeared to be dissemination.”) Most other participants tility than by a genuine desire to ease the aware that other couples shared this prob- heard about it through the newspaper, contraceptive burden that has been large- lem: “Sometimes when women take the television or radio, or from a friend. ly shouldered by their partners. pill, they have side effects…and when When men were encouraged by their The men and their partners appeared to they complain we get tired of it.”

76 International Family Planning Perspectives Participating in the clinical trial afford- I had control of my own sexuality, my wife tive implant: “My wife has gone through ed several discussants the opportunity to was feeling better and easier to deal with. many problems with contraceptives. Nor- observe a change in their partners once It was a small sacrifice to make, really.” plant gave her the most problems. I don’t they were off the pill. Several men per- think every woman can take it safely, since ceived that their partner’s libido improved: Problems with Other Methods it causes hormonal changes. It interferes “My wife didn’t like having sex when The men were also very critical of the con- with our religious practice also. Muslim she was on the pill. When I was on the dom, which was clearly not a method they women cannot perform usual religious ‘male pill,’ I liked having sex more and she expected to use in a stable relationship: rites during menstruation. Sometimes it felt comfortable.” “Neither of us liked condoms. We tried is difficult to tell whether the bleeding is “This program has had a lot to do with withdrawal and that’s why we have a menstrual or due to Norplant.” spontaneity in sex, for me anyway, and for three-year-old.” A substantial number of discussants her as well. It really had a big impact. With As one Scottish participant described mentioned vasectomy as a possibility in the pill she was never in the mood any- the difficulties of negotiating condom use: the future. Most of the men who did so way, so…” “Some forms of contraception can also were young and were concerned about the Other participants were more con- cause relationship problems. You don’t irreversibility of this decision: cerned with the perceived health impact like wearing condoms and the wife is in- “You see people that have had vasec- of long-term pill use: “My wife had been sisting—I mean, that can create problems. tomies, and they go through the hassle of on the pill for about 12 years and she was Whereas this was perfect. Both partners reversal because relationships break up, a smoker, in her early 30’s, and she was were quite happy with it.” and they form a new relationship where concerned.” One discussant perhaps overstated the there is a desire to have a child.” “It’s not good to take a lot of pills. You disadvantages of the condom: “Most “I think I have become more open to the get thin and it’s no good for the body.” women are allergic to the condom. They option of vasectomy after this trial, seeing There were also concerns, particularly don’t like it—it’s itchy. There are many that it didn’t really change my lifestyle.” among Thai men, about their wives for- problems with the condom.” getting to take the pill: Australian participants were usually Spousal Communication “She’s lazy about taking the pill…She more explicit: “The idea of having sex is The men who volunteered to participate wanted me to try it so she wouldn’t have that you get to put your bit inside her bit, in the clinical trials might see themselves to take the pill.” so you don’t want to wrap it up in a bit of as being in more egalitarian, less patriar- “She forgets to take it often. Sometimes rubber…sensuality is really important.” chal relationships than others. How did she tells me to remind her, but I forget.” Although focus group participants gen- the participants, and their partners, decide Such forgetfulness can lead to mistrust erally knew of a number of methods they on such matters as contraception and par- and to fear of pregnancy. For this reason had not tried, some remarks indicated ticipation in the trials? How frequently did and several others, a number of Thai dis- they perceived the lack of alternatives to they discuss sensitive issues and how cussants mentioned that they preferred to be greater than it actually is: “The gener- comfortable were they in doing so? take the responsibility for contraception al consensus with my friends is everybody The Australians went into considerably and welcomed the opportunity to have a hates the condom and it seems like the al- more depth in their discussions of gender reversible, effective method that they could most automatic alternative is that they’ll expectations and decision-making than control. For a few of these men, freeing their have to go back to the pill.” This partici- did the other groups. These discussions re- wives from a burden was secondary to pre- pant may have ruled out such well-known vealed a group of reflective men who were ferring to take the initiative themselves: methods as the diaphragm and the IUD; struggling with changing gender roles; this “She can forget to take the pill. It’s eas- both these methods had negative reputa- change in roles and expectations may fur- ier to come every Wednesday for injec- tions among respondents, which were ther the demand for male methods of fer- tions. Then I feel better if I’m the one who generally not related to actual experience. tility regulation. There was a streak of ide- gets to do it.” Only about 24% of the questionnaire re- alism in their comments, as well as a “The man should do the controlling be- spondents had used a barrier method recognition that privilege has its price: cause women have a lot of problems. If other than the condom. “My wife and I are both independent of they take the pill, they have problems, Some problems with a method were each other. It’s part of the new way. We are then they have to get injections, and they clearly less serious than others. As one both bread winners, we both do the work also have side effects. Men don’t seem to questionnaire respondent wrote in: “My and share everything equally. She tells me have as many problems.” partner comes back to bed freezing after what to do and I do my own thing…“ “I thought it would be more convenient putting the cap in.” “To a certain extent all those norms, if we men get the injections. Women some- Some participants expressed the belief morals and values are raised into promi- times don’t have the time while we can that an untried but highly effective meth- nence because we are precisely in that pe- spare some time.” od was preferable to one already known riod of change, so people are forced to Although non-Asian men were pri- and tried: “We want to have the most ef- think about: Do men have to do things a marily motivated by their partner’s prob- fective birth control method. Most of us certain way? What’s a typical male?” lems, some also enjoyed a sense of being who came were already using other meth- Asian men appeared less troubled by gen- in control: ods and we came because we thought this der issues and less questioning of their dom- “I felt quite neat then because, not only was a better way.” inant role than the non-Asian participants: was I furthering the cause of masculine And in some cases, side effects inter- “I feel that for men who are sole bread development, but I liked the idea of being fered with cultural practices, as in the case winners, when in the home they should re- in control of my own fertility.” of a Muslim discussant from Singapore spect their wives. However once outside, I “As far as I was concerned, I was happy, who noted problems with the contracep- think men should make the final decision.”

Volume 21, Number 2, June 1995 77 Acceptability of a Hormonal Method for Men

The Thai men were also more forth- “It was totally a two-way thing with my In addition to the discomfort of injec- coming about extramarital affairs, and partner. We actually read about it when tions, the participants were required to given the sexual freedom of men in Thai she was having a checkup. We decided to provide periodic blood samples and society, were more likely to be openly non- try it. She was involved in it all the way semen specimens every two to four weeks: monogamous (participants in the other through. “ “I don’t think the needles were as bad as focus groups did not raise the issue): “My wife was so involved she was the the idea of hanging around outside col- Moderator: “When you have other one who gave the injections.” lection rooms waiting for one to become women, do you feel guilty?” Participant: As shown in the table, about one-quar- vacant…People know why you are stand- “Only for a short moment.” (Laughter). ter (23%) of respondents to the question- ing there with your little white paper bag.” “Women can lose their honor because naire indicated that their spouse’s en- Moreover, most, but not all, discussants if they go running around and people find couragement was the most important experienced one or more side effects such them and they talk, the gossip soon reason for joining the study. Several re- as acne, weight gain, increased muscle spreads to the family. For men, it’s not a spondents admitted that they had felt mass and a small reduction in testicle size: shameful thing, but instead it’s an expe- pressured by their partners to participate “I’ve never been a person with pimples, rience in life.” in the clinical trial: but I started to get a few across my back, What bearing do these attitudes have “For me, yes, because my wife experi- quite monstrous ones. A very painful on men’s use of contraception? Men in dif- enced a lot of problems when using female process to get rid of them.” ferent societies may be motivated to use contraceptives. As a result, she stopped “I found, too, that I started sweating a a male method for different reasons. For using it and therefore the responsibility lot around the neck. I would wake up and example, while many participants in the of taking contraception lies with me.” my pillow was wet. I’ve never had that be- study felt that a method for men was a “My wife wanted me to come. At first fore. That’s the only change I found. I felt matter of simple justice, there were cul- I was afraid, I wouldn’t come. She want- better, I think that might be more psy- tural differences in the reasoning behind ed me to try it so she wouldn’t have to take chological than anything, because my this. Thai participants were more con- the pill.” friends used to say ‘have you been in for cerned than others about their right to con- The way the participants perceived this your man drug?’ Perhaps I feel more trol fertility and with the consequences of pressure was related to their perception manly.” not doing so: of men’s gender roles. As one discussant “I used to teach sex education and “If you’re going to have a relationship remarked: “What more pressure is there teaching kids testicular self examination, with someone, you don’t know if the than a woman wanting you to be a man?” you get to know your balls fairly well, so woman is taking the pill or not. We don’t yes, they became more spongy—a change know if women want to catch us or not.” Side Effects in consistency as well as volume, but not “If she says she wants to have another Despite most participants’ enthusiasm for shriveling up to the size of cashews.” child, I might say I don’t want her to suf- the method, a considerable portion of the “I actually did enjoy having the eight fer or have to carry the baby for many discussion among focus group partici- extra kilos of muscle. It was nice to have months and so on. But in actual fact it’s be- pants at each center concerned side effects. extra bulk to bench press, but the pimples cause I don’t want to have any. I think it In the original 1986–1990 study, 11 men were my main problem.” (This amount of should be the husband” [who makes the (4%) dropped out because of the pain or weight gain was unusual, as participants decision]. frequency of the injections.7 Although the experienced an average weight gain of less Most of the Thai participants also had focus groups revealed a wide variation in than 4%.8) completed their families and were con- the level of discomfort, for some men, the Increased irritability was potentially the cerned about the economic consequences shots were clearly unpleasant: most serious side effect mentioned by a of an unwanted pregnancy: “I have two “I could live without weekly injections. few participants; however, ascertaining the and that’s enough for me. I’m trying not They were fairly uncomfortable.…On one true frequency of this type of side effect to have any more because we have a fixed or two occasions my arm was dead for and establishing its relationship to testos- amount of income. If we have more, that two or three days.” terone injections is problematic, since most will be hard on us.” “Before the pain is gone from the last in- participants did not keep diaries and pe- The non-Asian focus group participants jection, you have to get another. This in- riodic assessments of mood were rare: were more likely to express guilt about not jection doesn’t go fast. The fluid is kind of “During the study there was only one having taken contraceptive responsibili- thick so they have to push it slowly.” major episode and it was a doozy. It might ty earlier in their lives: “In years gone past “Let’s face it—you have to be a bit of a have happened anyway. You don’t know I never gave contraception a second loony to get one stuck in your buttock if it was the testosterone.” thought. I always had the onus on the every week.” “I think if you are in touch with your woman to provide any contraception, and But most men adapted to the regime emotional makeup, it’s not hard to see I thought that was a downer and maybe and some even surprised themselves in changes. To me it did make a difference, I should start taking responsibility.” These the process: it did aggravate it, but it wasn’t insur- men typically saw their partners as an in- “I was the sort of person who shied mountable. I just found that I wasn’t pre- tegral part of the study, whether or not away from needles, ran away from nee- pared for it. It took me a couple of months they had made the decision to participate dles, fainted, the lot; then after a couple before I asked myself—what changed? It together: of weeks it didn’t bother me.” was the lack of preparation. I had to start “A joint decision, but I was probably “Believe it or not I’m actually adept at taking more physical exercise, taking more pro than my wife. She is a bit old giving it to myself in the bum…it’s amaz- walks and I had to start counting from one fashioned as if—you never go into ing what you’ll actually do when you to 10 before I picked up something and surgery, never try volunteering…“ have to.” threw it.”

78 International Family Planning Perspectives “As far as I’m aware my stress level was that they were similar to others. For ex- “I told a lot of males about it because…I still the same as it is now.” ample, Thai and Singapore men made the felt quite proud about the fact that I was One participant found that he had less following statements: on it. I thought it was a great thing to do. tolerance for stressful situations at work: “I see myself as any other man on the Probably out of the maybe 50 guys I told, “It was easy at home. I’m a bartender. With street.” [another member of the focus group] was customers [I felt] more confrontational.” “I think we are more or less the same.” the only one who considered it…I thought Furthermore, partners of participants were “We shouldn’t be a lot different.” a lot more people would have said ‘that not interviewed: “I think part of the ques- Yet in response to the same question on sounds great.’” tion you’re asking is whether my wife was whether they felt different from the typi- Thai men said they had been envied: aware of it [changes in mood] and she cal man, non-Asians offered the follow- “Many of my friends want to come.” But never volunteered that she was.” ing remarks: they also reported being teased by their Most focus group participants said they “I figure that the people who are doing colleagues since, as is also true for vasec- experienced a welcome side effect—a this program are a different kind of guy tomy, there was a common misperception moderate increase in libido (of about anyway, we’re not SNAGS [sensitive new that impotence could result. Other Thai 10–20%) during the trial. Even though the age guys]…I don’t think we are typical of men thought that although friends might diaries kept by trial participants from the white Australian middle class society.” want to try the method, their wives’ neg- United Kingdom revealed no increase in “In general I would say that most men ative attitude would present an obstacle: the frequency of sexual intercourse, dis- that I’m close to are SNAGS…it would be “The men want to come but the women cussants said they fantasized about sex hard for me to have a friend that is a male don’t want them to. They’re afraid they more frequently and experienced more in- chauvinist…I just don’t get along with will not have children.” tense pleasure during intercourse: them very well.” However, U.K. discussants mentioned “My sex drive certainly changed. It in- “We all know that at this stage of time, that women often seemed more receptive creased and pleasure increased. It was a it’s not socially acceptable for male con- to the idea than men: bonus.” traception. We are doing this because we “Response from other people ranged “It definitely increased my sex are different.” from disbelief because they didn’t know drive…no question about it. It’s tapered Did the participants believe that other it existed to the women saying to their off considerably since then. I would say men would use such a method when it be- husbands ‘Why don’t you get on that?’ probably in a month, something like that, comes available? They all thought it was a good idea.” I started noticing the difference.” “It depends on how well educated they “Females seem to like it.” One discussant noted that his increased are. It would take 10 or 20 years really for “…which is interesting because when sex drive was not always welcomed by his it to be accepted…it would take a whole you get a program on the tele[vision] and partner: “She only asked me why it’s get- social consciousness.” they ask women on the street, they always ting too often.” The possibility that free- “Well, I think if the injection is really ef- say they wouldn’t trust a man on the pill, dom from the fear of pregnancy may have fective, all men will get it because they but when you really ask them properly, in also played a role in increased libido can- don’t have to worry about getting women a stable relationship, they obviously do.” not be ruled out: “We were less inhibited. pregnant and so on.” “We found there was more interest in When there was no chance of my wife get- “The important thing is the promotion. the study amongst our female friends, in ting pregnant, we could just take that out If the rural people learn about it, if there’s fact, quite a few probably would have of our minds and be as natural with each good dissemination, they would join.” been interested in [having their partner other as possible.” Of the men who filled out the ques- participate] if they had known about it.” The above quotes suggest that obtain- tionnaire, the majority (65%) indicated At least among the non-Asian focus ing the partner’s perspective on changes they would recommend participation in group participants, there was an ac- in mood and libido is essential to estab- the clinical trial to others, even with its dif- knowledgment that: “Stable relationships lishing the acceptability of the method. An ficult weekly injection regimen. A much are where it’s going to work.” improved presently under more substantial majority (82%) indicted study is expected to reduce, if not elimi- they would prefer a three-month in- Discussion and Conclusions nate, changes in mood and libido. Ad- jectable version of the male hormone, if it The data from these focus group discus- dressing these potential side effects is cru- were available, to their current method. sions and the post-study questionnaire cial, since many participants entered the Most focus group discussants were also demonstrate the valuable contribution that trial precisely because their partners were enthusiastic about the method and were clinical trial participants can make toward experiencing severe side effects. disappointed when their friends and col- identifying issues that might influence leagues were less so: how the general public would accept a The Method’s Future “You still get people who would say new contraceptive method. One such issue A key question is how well a hormonal ‘What are you doing that for, can’t your is changing gender expectations, which is method for men would be accepted by the wife take the pill or something?’ It seems likely to increase support for a reversible, general public. Were these men atypical like the abnormal rather than the normal, noncoitus-dependent method for men. and thus unlikely to be numerous in the the idea that the bloke, apart from con- The previous contraceptive problems general population? Did they distinguish doms, would actually take any part of sex- experienced by many of the clinical trial themselves from others or feel that they ual responsibility for contraception, par- participants or their partners may not be were just average citizens? The partici- ticularly not one which involved needles.” representative of those experienced by the pants were divided about whether they “A lot of guys said it sounded like a re- population at large. The severity of their were “typical” in any sense, with Asian ally good idea but wouldn’t actually com- difficulties may be what distinguishes the men more likely than non-Asians to feel mit themselves.” participants from other couples, and thus

Volume 21, Number 2, June 1995 79 Acceptability of a Hormonal Method for Men what led them to join the study. The extent that this particular hormonal regimen can problems that the participants’ partners of dissatisfaction with current methods potentially cause will be addressed in fu- had with female methods, counter the as- needs further exploration, as the issue has ture clinical trials by altering the prepa- sertion that there are already sufficient myriad implications, including method ration used so that normal levels of the contraceptive options. For these reasons— continuation rates, compliance with a hormone will be maintained, rather than the absence of equity and the dissatisfac- method’s protocol and, ultimately, the temporarily exceeded. Researchers are tion with existing female methods—the prospects for new methods. currently developing methodologies, such development of methods to regulate male The frequency of injection was the most as assessing reactions to hypothetical fertility appears justified and desirable. common deterrent to the acceptability of provocation, to identify whether the new the method for the clinical trial participants. formulations of the hormone have suc- References Although injections are associated with cessfully dealt with these concerns. 1. G. M. H. Waites, “Male Fertility Regulation: The Chal- good health in some Asian cultures, clear- Social and biomedical scientists may lenges for the Year 2000,” British Medical Bulletin, ly, they were viewed less positively by the view participants’ support for a hormon- 49:210–221, 1993. Australian, U.K. and U.S. participants. al method for men as particularly en- 2. World Health Organization (WHO) Task Force on While another mode of delivery might be couraging, whether these men are repre- Methods for the Regulation of Male Fertility, “Contra- preferable to some, most participants sentative of the general population or not. ceptive Efficacy of Testosterone-Induced Azoospermia agreed that a less frequent injection regime Men from the several countries studied in Normal Men,” Lancet, II:955–959, 1990. would also be acceptable (and some ad- found an injectable to be a more conve- 3. WHO, Annual Technical Report, Special Programme of mitted that they were as likely, if not more nient, hassle-free method compared with Research, Development and Research Training in Human so, as their wives to forget to take a pill). what they were currently using. The meth- Reproduction, Geneva, 1992; and WHO Task Force on Most participants viewed the effects of od also offered an answer to their belief Methods for the Regulation of Male Fertility, “Rates of weight gain and increased muscle mass in a right to control their own fertility and Testosterone-Induced Suppression to Severe Oligo- as advantageous, and were not alarmed a solution to the dilemma of sharing con- zoospermia or Azoospermia in Multinational Clinical by the slight reduction in testicle size. The traceptive responsibility with their part- Studies,” Fertility and Sterility, forthcoming, 1995. most significant number of complaints ners. One participant expressed a view 4. S. A. Matlin, “Prospects for Pharmacological Male was for acne. There is clearly a need for shared by others: “I think it is a very Contraception,” Drug, 48:851–863, 1994. further exploration of the range and sever- worthwhile investigation. It’s not only un- 5. G. M. H. Waites, 1993, op. cit. (see reference 1). ity of side effects experienced by men fair to make contraception a female re- using a hormonal method. By the same sponsibility, but it only addresses half the 6. M. E. Khan and L. Manderson, “Focus Groups in Trop- token, it should not be forgotten that many people involved.” ical Disease Research,” Health Policy and Planning, 7:1–11, women continue to use the pill and other Depending, in part, on the availability 1992; and J. Knodel et al., “Fertility Transition in Thai- land: A Qualitative Analysis,” Population and Develop- methods despite their experience of side of research funding, a modified or com- ment Review, 10:297–328, 1984. effects. Several participants noted that bined version of the product these par- they had had fewer problems with side ef- ticipants tested could be ready for more 7. WHO Task Force on Methods for the Regulation of fects from the male hormone injections wide-scale introductory trials by the year Male Fertility, 1990, op. cit. (see reference 2). than their partners had had with the pill. 2000. The present lack of reversible non- 8. WHO Task Force on Methods for the Regulation of The increases in irritability and libido barrier alternatives for men, as well as the Male Fertility, 1995, op. cit. (see reference 3).

80 International Family Planning Perspectives