sign in sign up
<<
Home , Hormonal IUDs

MAY 2015 Vol. 36, No. 5; p. 49-60 INSIDE Options expand for women: FDA

Intrauterine device: approves a new LILETTA new hormonal option ...... Cover LILETTA joins Mirena and Skyla as hormonal intrauterine options

LARC effectiveness: he Food and Drug Administration e-mail is on file. Contact AHC Media Research eyes (FDA) has announced Customer Service at customerservice@ effectiveness beyond approval of a new option ahcmedia.com or (800) 688-2421.] the duration on the T in intrauterine contraception: the The reduced public sector pricing label...... 52 LILETTA intrauterine device (IUD). will help providers offer effective, safe, EC: Research looks Medicines360, a San Francisco-based and affordable medicines to all women, at impact of body nonprofit pharmaceutical company, regardless of socioeconomic status, said weight, BMI. . . . . 53 and Actavis, a Dublin, Ireland- Wayne Shields, chief executive officer based pharmaceutical company, have of the Association of Reproductive : How to get announced that the device will be Health Professionals. “The launch of the message across to offered on the commercial market, as LILETTA marks an important advance young men. . . . . 55 well as at reduced cost to public health in contraceptive access and reproductive Menopause: Counsel clinics enrolled in the federal 340B agency for women across the United women on vasomotor Drug Pricing Program. States,” said Shields in a press statement. symptoms ...... 57 The device is expected to be LILETTA is a flexible, plastic available in the second quarter of 2015. T-shaped system, measuring 32 mm Young women: Help Providers who are interested in receiving by 32 mm. It releases the progestin bridge the provider information on market availability of the at an initial release rate transition...... 59 device can sign up for e-mail alerts at the of 18.6 mcg per day, with an average in Enclosed in this issue: product’s provider site, www.lilettahcp. vivo release rate of approximately 15.6 com. [Editor’s note: Contraceptive mcg per day over three years. The device 1 • Reader Survey Technology Update posted information is labeled for three years of effective use. on the FDA approval on Feb. 27, 2015, The device is similar in size to the on the ahcmedia.com web site and alerted currently marketed Mirena ( readers by e-mail. If you didn’t receive an Healthcare Pharmaceuticals, Wayne, e-mail alert, please make sure your current NJ), says Andrew Kaunitz, MD,

NOW AVAILABLE ONLINE! VISIT www.ahcmedia.com or CALL (800) 688-2421

Financial Disclosure: Consulting Editor Robert A. Hatcher, MD, MPH, Editor Rebecca Bowers, and Executive Editor Joy Dickinson report no consultant,­ stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Melanie Deal, nurse reviewer, discloses that she formerly was on the speakers bureau for Merck & Co. University of Florida Research now marketed as ParaGard, arrived Foundation professor and associate on the scene, it was approved for chairman of the Department of just four years, states Hatcher. The Obstetrics and Gynecology at the appropriate counsel for a woman Contraceptive Technology Update® ISSN 0274-726X, is published monthly by University of Florida College of receiving the Copper T IUD at that AHC Media, LLC One Atlanta Plaza Medicine — Jacksonville. LILETTA time was “this IUD is effective for at 950 East Paces Ferry Road NE, Suite 2850 Atlanta, GA 30326. is labeled for three years of effective least four years,” not “this IUD must Periodicals Postage Paid at Atlanta, GA 30304 and at additional mailing offices. use; Mirena is labeled for five years of be removed after four years,” Hatcher effective use, notes Kaunitz. observes. POSTMASTER: Send address changes to: Contraceptive Technology Update The two levonorgestrel IUDs, Six to eight years ago, one could P.O. Box 550669 Atlanta, GA 30355. Mirena and LILETTA, appear refer to “the levonorgestrel IUD”

SUBSCRIBER INFORMATION: to be identical in terms of size and know it referred to Mirena. This Customer Service: (800) 688-2421. [email protected]. and elaboration of the progestin is no longer the case, says Hatcher. www.ahcmedia.com levonorgestrel, says Robert Hatcher, Mirena, LILETTA, and Skyla (Bayer Hours of operation: 8:30 a.m. - 6 p.m. Monday-Thursday; 8:30 a.m. - 4:30 p.m. Friday, EST. MD, MPH, professor emeritus of Healthcare Pharmaceuticals, Wayne, EDITORIAL QUESTIONS OR COMMENTS? gynecology and obstetrics at Emory NJ) are all levonorgestrel IUDs, notes Call Joy Daugherty Dickinson (404) 262-5410 or Email: [email protected]. University School of Medicine in Hatcher.

SUBSCRIPTION PRICES: Atlanta. Hatcher points to A Clinical Print: 1 year with free AMA PRA Category 1 CreditsTM: $479. How effective is it? Add $19.99 for shipping & handling. Guide for Contraception, which states, Online only: 1 year (Single user) with free AMA PRA “The levonorgestrel intrauterine In a multicenter open-label Category 1 CreditsTM: $429 system can be used for at least seven clinical trial that included 1,751 MULTIPLE COPIES: Discounts are available for group 2 subscriptions, multiple copies, site-licenses or electronic years, and probably for 10 years.” women ages 16-45, LILETTA was distribution. For pricing information, call Tria Kreutzer at 404-262-5482. Canada: $509 per year plus GST. Elsewhere: This statement would suggest that found to be 99.45% effective in $509 per year. the new LILETTA IUD ultimately preventing in women Back issues: $75. Missing issues will be fulfilled by will be shown to be effective for more regardless of age, parity, or body mass customer ­service free of charge when contacted within one month of the missing issue’s date. than the three years for which it is index (BMI). The study is ongoing to GST Registration Number: R128870672. approved, he notes. evaluate the use of the device for up ACCREDITATION: AHC Media is accredited as a provider of continuing nursing education by the American Nurses “This means that when we to four, five, and seven years. Credentialing Center’s Commission on Accreditation. communicate with patients about The IUD was studied in women This activity has been approved for 1.25 nursing contact the LILETTA IUD, we should not with a mean BMI of 26.9 kg/m3. hours using a 60-minute contact hour. Provider approved by the California Board of Registered say, ‘This IUD must be removed in The clinical trial included overweight Nursing, Provider #14749, for 1.25 Contact Hours. AHC Media is accredited by the Accreditation Council three years,’” says Hatcher. “What (24%), obese (24%), and morbidly for Continuing Medical Education to provide continuing medical education for physicians. we should say is that this IUD is obese (5%) women. Researchers note

AHC Media designates this enduring material for effective for at least three years.” that while levonorgestrel systemic a maximum of 1.5 AMA PRA Category 1 Credits™. When the copper T380A IUD, exposure decreased with increasing Physicians should claim only credit commensurate with the extent of their participation in the activity. This activity is intended for OB/GYNs, nurses, nurse practitioners, and other family planners. It is in effect for 24 months from the date of publication. EXECUTIVE SUMMARY Opinions expressed are not necessarily those of this publication. Mention of products or services does A new option in intrauterine contraception has been approved: the LILETTA not constitute endorsement. Clinical, legal, tax, and other comments are offered for general guidance only; intrauterine device . ­professional counsel should be sought for specific situations. • Pharmaceutical companies Medicines360 and Actavis have partnered to

EDITOR: Rebecca Bowers offer the device on the commercial market, as well as at reduced cost to EXECUTIVE EDITOR: Joy Daugherty Dickinson (404) 262-5410 public health clinics enrolled in the federal 340B Drug Pricing Program . CONTINUING EDUCATION & EDITORIAL DIRECTOR: LILETTA is expected to be available in the second quarter of 2015 . Lee Landenberger • A flexible, plastic T-shaped system, the device measures 32 mm by 32 Copyright© 2015 by AHC Media, LLC. Contraceptive Technology Update® and STI QuarterlyTM are trademarks mm in size . It releases the progestin levonorgestrel at an initial release rate of AHC Media. The trademarks are herein used under license. All rights reserved. No part of this newsletter of 18 .6 mcg per day, with an average in vivo release rate of approximately may be reproduced in any form or incorporated into any information-retrieval system without the written permission 15 6. mcg per day over three years . LILETTA is labeled for three years of of the copyright owner. effective use .

50 | CONTRACEPTIVE TECHNOLOGY UPDATE® / May 2015 body weight, there was no apparent women who discontinued the study from vaginal intercourse for seven effect of BMI or body weight on early, 97% returned to menses within days to prevent pregnancy. contraceptive efficacy.1 three months after the device was If women are switching from oral, About 60% of trial participants removed. transdermal, or vaginal hormonal were nulliparous. The following The incidence of ectopic contraceptives, LILETTA may be women were excluded: women with pregnancy in the clinical trial, which inserted at any time. It may be a history of , pelvic excluded women with a history of inserted during the hormone-free inflammatory disease, trophoblastic ectopic pregnancy who did not have interval of the previous method. If disease without a subsequent a subsequent intrauterine pregnancy, it is inserted during active use of the intrauterine pregnancy, who were was approximately 0.12% per 100 previous method, the prescribing less than four weeks post-pregnancy, woman years. information indicates to continue had HIV, or were not in a mutually In the clinical trial, an overall the previous method after device monogamous relationship at study expulsion rate of 3.5% was reported, insertion for seven days or until the entry. with a rate of 2.0% in nulliparous end of the current cycle. If a woman The pregnancy rate calculated as women and 5.6% in parous women. is using continuous hormonal the (PI) in women ages 16 Expulsion might be associated with contraception, the method should be to 35 years, inclusive, was the primary symptoms of bleeding or pain, or discontinued seven days after device efficacy endpoint used to assess it might be asymptomatic and go insertion.1 contraceptive reliability, researchers unnoticed. LILETTA typically Women using the contraceptive note.1 The index was calculated based decreases menstrual bleeding injection who wish to switch to on 28-day equivalent exposure cycles. over time; therefore, an increase LILETTA can have the device Evaluable cycles excluded those in in menstrual bleeding might be inserted at any time. A barrier which back-up contraception was indicative of an expulsion, researchers method of contraception, such as used unless a pregnancy occurred note.1 condoms and , also should in that cycle. The Year One PI was In the contraceptive trial, 12.3% be used for seven days if the device based on two , and the of LILETTA users discontinued is inserted as instructed more than cumulative three-year pregnancy prematurely due to an adverse three months (13 weeks) after the last rate was calculated by the life table reaction. The most common adverse injection. method, based on a total of six reactions leading to discontinuation The use of LILETTA is pregnancies that occurred after the were expulsion (3.5%) and bleeding contraindicated in women with the onset of treatment and within seven complaints (1.5%). The next most following: days after LILETTA removal or common adverse reactions causing • known or suspected pregnancy; expulsion. discontinuation were acne (1.3%), • congenital or acquired uterine The cumulative pregnancy rate mood swings (1.3%), anomaly, including fibroids if they (95% confidence interval [CI]) in the (0.6%), and uterine spasm (0.6%). distort the uterine cavity; Year One PI was calculated at 0.15 Two women discontinued the • known or suspected (0.02, 0.55) based on 17,125 28- clinical study due to PID, and one or other progestin-sensitive cancer, day cycles of exposure. Cumulative discontinued due to endometritis. now or in the past; pregnancy rate (95% CI) for the Check insertion times • known or suspected uterine or cumulative three-year life table was cervical neoplasia; calculated at 0.55 (0.24,1.23), based If a woman is not using a form • liver disease, including tumors; on 34,711 28-day cycles of exposure.1 of or an • untreated acute or What can users expect? IUD, LILETTA can be inserted any vaginitis, including lower genital time there is reasonable certainty the tract infections, until infection is Approximately 19% of women woman is not pregnant. If the device controlled; treated with LILETTA experienced is not inserted during the first seven • postpartum endometritis or within one year of days of the , a barrier infected in the past three treatment, and more than one-third method of contraception, such as months; experienced amenorrhea by the third condoms and spermicide, should be • unexplained uterine bleeding; year of treatment. In an analysis of used or the patient should abstain • current IUD;

50 | CONTRACEPTIVE TECHNOLOGY UPDATE® / May 2015 CONTRACEPTIVE TECHNOLOGY UPDATE® / May 2015 | 51 • acute pelvic inflammatory disease information. Accessed at http://bit. component of the device. (PID) or history of PID (except with ly/1CdbHt0. later intrauterine pregnancy); 2. Speroff L, Darney PD. A Clinical Guide REFERENCES • conditions increasing for Contraception. Philadelphia: susceptibility to pelvic infection; 1. LILETTA (levonorgestrel-releasing Lippincott Williams & Wilkins; • hypersensitivity to any intrauterine system) prescribing 2011. n Intrauterine device and are effective beyond use approved by the FDA n initial analysis of data participation has given researchers a opportunity to show the devices are A conducted by Washington unique opportunity to study a cohort still effective, in different populations University School of Medicine in of women using these methods for of users,” says McNicholas, who St. Louis indicates that hormonal a longer time, McNicholas observes. served as lead author of the current intrauterine devices (IUDs) and The Contraceptive CHOICE Project paper. “This improves the cost- contraceptive implants remain highly was a prospective cohort study of effectiveness of the device and helps effective one year beyond their reproductive-aged women in St. Louis women avoid unnecessary removals/ approved duration of use.1 designed to promote the use of LARC re-insertions.” The subdermal by eliminating cost, access, and Review the research implant (Nexplanon, Merck, knowledge barriers. Whitehouse Station, NJ) and the The present study, known as the Women participating in the EPIC 52-mg levonorgestrel IUD (Mirena, Effectiveness of Prolonged use of the analysis were ages 18 to 45, and Bayer Healthcare Pharmaceuticals, IUD and Implant for Contraception their contraceptives had to be within Wayne, NJ) represent two of the (EPIC) study, is seeking to fill gaps six months of expiring when they most effective forms of reversible in the literature regarding extended enrolled. The women were informed contraception available with a use of the etonogestrel implant and of a possible risk of pregnancy if failure rate of less than 1% over the 52-mg levonorgestrel IUD. It aims the devices were used beyond the respective three-year and five-year to enroll a total of 800 women. The duration of use approved by the Food durations approved by the Food and currently published initial analysis and Drug Administration. Drug Administration. Data indicate included 237 women who used Unintended pregnancy rate per both devices provide effective use implants and 263 women who used 100 women-years was calculated. past their approved durations. Three hormonal IUDs. To check serum etonogestrel levels, studies in which a total of 275 “This study gives us an implant users were offered periodic women used the etonogestrel implant Implanon for longer than three years found no pregnancies during the EXECUTIVE SUMMARY fourth year of use. A 2014 systematic An initial analysis of data conducted by Washington University School of review concluded that the 52-mg Medicine in St . Louis indicates that hormonal intrauterine devices (IUDs) levonorgestrel IUD could be used and contraceptive implants remain highly effective one year beyond their safely for up to seven years.2,3 approved duration of use . The Contraceptive CHOICE • The etonogestrel subdermal implant and the 52-mg levonorgestrel IUD Project had an “amazing” uptake represent two of the most effective forms of reversible contraception and continuation of long- available with a failure rate of less than 1% over the respective three-year acting reversible contraception and five-year durations approved by the Food and Drug Administration . (LARC) among its participants, • Study findings indicate the devices still are effective in different says Colleen McNicholas, DO, populations of users past their approved duration of use . This duration MSCI, assistant professor in the improves the cost-effectiveness of such devices and helps women avoid Washington University School unnecessary removals/re-insertions, researchers state . of Medicine’s Obstetrics and Gynecology Department. This level of

52 | CONTRACEPTIVE TECHNOLOGY UPDATE® / May 2015 venipuncture. The Kruskal-Wallis test, implants jumped five-fold between University School of Medicine in St. a form of statistical analysis, was used 2002 and 2011, according to a new Louis. “In the long term, this work to compare the etonogestrel levels U.S. government report.4 Among has the potential to change how across (BMI) groups. women ages 15 to 44, the use of such we provide contraceptive methods The researchers documented no long-term reversible contraceptives around the world and can enable pregnancies in the implant group and rose from 1.5% in 2002 to 7.2% women to control their reproductive one pregnancy in the IUD group. in 2011-2013, according to the health and family size.” This failure rate is similar to that of Centers for Disease Control and REFERENCES IUDs used within the recommended Prevention report. (For more on five-year window, researchers note. contraceptive use, see “Statistics show 1. McNicholas C, Maddipati R, Zhao Q, Scientists will continue to follow more use of LARC — How can you et al. Use of the etonogestrel implant the women and others who enroll maintain momentum?” Contraceptive and levonorgestrel intrauterine in the study. The final results will Technology Update, March 2015, p. device beyond the U.S. Food and determine if the 52-mg levonorgestrel 25.) Drug Administration-approved IUD and the With more women moving to duration. Obstet Gynecol 2015; are effective for up to three years LARC methods, the continued 125(3):599-604. beyond their approved duration of follow-up of the EPIC study 2. Raymond EG. Contraceptive implants. use. participants will provide data In: Hatcher RA, Trussell J, Nelson It will be important to study that might change the provision AL, et al. Contraceptive Technology: the mechanism of action for the of contraceptive services. The 20th revised edition. New York: implant during its fourth year of use, potential to further improve the Ardent Media; 2011. says Anita Nelson, MD, professor cost-effectiveness by extending the 3. Wu JP, Pickle S. Extended use of in the Obstetrics and Gynecology life of these devices could provide the intrauterine device: A literature Department at the David Geffen “tremendous” economic benefit to review and recommendations for School of Medicine at the University insurers and to society, researchers clinical practice. Contraception 2014; of California in Los Angeles. Many state. 89:495-503. turn to the implant because it so “The longer a contraceptive 4. Daniels K, Daugherty J, Jones J. reliably suppresses , she says. method is effective, the bigger the Current contraceptive status among LARC is catching on impact it can have,” said co-author women aged 15-44: United States, Jeffrey Peipert, MD, PhD, the 2011–2013. NCHS data brief, no 173. The use of LARC methods is Robert J. Terry Professor of Obstetrics Hyattsville, MD: National Center for catching on. Use of IUDs and and Gynecology at Washington Health Statistics. 2014. n Research eyes effect of body weight and BMI impact on esults of a new statistical or obese women, had decreased efficacy to evaluate the effect of R analysis of clinical data suggest efficacy in preventing pregnancy.2 weight and BMI on pregnancy a significant drop in the efficacy (Contraceptive Technology Update rates among women who received of levonorgestrel emergency reported on the data in the article, levonorgestrel.3,4 contraception (EC) with increasing “Hope vs. reality — Access to EC pills The researchers used descriptive body weight.1 doesn’t work,” January 2013, p. 8.) methods, such as comparing means Questions of whether body To further evaluate the effect and distributions according to mass index (BMI) or weight might of weight and BMI on the efficacy pregnancy status and pregnancy rates influence the efficacy of EC first were of levonorgestrel emergency across weight and BMI categories, raised when findings from a 2011 contraception, researchers pooled as well as cubic spline modeling, to analysis indicated that levonorgestrel, data from two large, multicenter, describe the relationship between when taken for emergency randomized controlled trials designed pregnancy risk and weight/BMI. contraception among overweight to assess emergency contraceptive Cubic spline modeling utilizes five

52 | CONTRACEPTIVE TECHNOLOGY UPDATE® / May 2015 CONTRACEPTIVE TECHNOLOGY UPDATE® / May 2015 | 53 predictions of the pregnancy rates corresponding to five percentiles (the EXECUTIVE SUMMARY first, third, fifth, seventh, and ninth Results of a new statistical analysis of clinical data suggest a significant drop deciles) of the distribution of the in the efficacy of levonorgestrel emergency contraceptive pills (ECPs) with data. increasing body weight . A total of 1,731 women were • Questions of whether body mass index (BMI) or weight might influence in the analysis population, and 38 the efficacy of ECPs first were raised when findings from a 2011 analysis pregnancies were reported. Women indicated that levonorgestrel, when taken for emergency contraception for whom levonorgestrel was not among overweight or obese women, had decreased efficacy in preventing effective in preventing pregnancy pregnancy . had a significantly higher mean body • Researchers pooled data from two large, multicenter, randomized weight and BMI than women who controlled trials designed to assess emergency contraceptive efficacy to did not become pregnant (76.7 versus evaluate the effect of weight and BMI on pregnancy rates among women 66.4 kg, p less than .0001; 28.1 who received such pills . For women weighing more than 75 kg (165 pounds), versus 24.6 kg/m2, p less than .0001). levonorgestrel ECPs were minimally effective . The estimated pregnancy rate increased significantly from 1.4% (95% confidence interval [CI]: 0.5%- mg tablets (Perrigo, Allegan, MI), progestin-only pills (e.g. Plan B) is 3.0%) among the group of women and AfterPill (Syzygy Healthcare virtually useless with women with a weighing 65-75 kg to 6.4% (95% Solutions, Westport, CT). BMI of 36 or greater.” CI: 3.1%-11.5%) and 5.7% (95% Publication of the new analysis • “Emergency contraception with CI: 2.9%-10.0%) in the 75-85 kg will spread enthusiasm for ulipristal ella is useless (ineffective) in women and above-85 kg groups, respectively, acetate, because most clinics are with a BMI of 35 or greater.”7 findings indicate. Statistical modeling not able to provide copper IUDs The copper intrauterine device demonstrated a steep increase in for emergency contraception, says (IUD) is the most effective form pregnancy risk starting from a weight Anita Nelson, MD, professor in of emergency contraception. It can near 70-75 kg to reach a risk of the Obstetrics and Gynecology be inserted up to five days after pregnancy of 6% or greater around Department at the David Geffen unprotected intercourse, which 80 kg. Similar results were obtained School of Medicine at the University reduces the risk of pregnancy by 99%. for statistical modeling of BMI, as of California in Los Angeles. It retains full efficacy over time and well as when the two studies were Study findings suggest that with obesity, and it provides ongoing analyzed individually, researchers (ella, Afaxys, contraception for up to 12 years.8 report.3 Charleston, SC) also is impacted by Clinicians also might want How to proceed? weight. It appears to lose effectiveness to consider a recently published at a higher BMI threshold of 35.2,6 commentary that calls for changes Clinicians need to take into Ulipristal acetate is available by in patient counseling for emergency consideration such data when talking prescription only in the United States; contraception, because typical with women about emergency it was approved in January 2015 for counseling doesn’t take into account contraception. Why? The average pharmacy over-the counter sales by the relative effectiveness of available U.S. woman now weighs 75 kg (165 the European Commission. methods or patient characteristics pounds).5 Robert Hatcher, MD, MPH, such as BMI.9 (For more information Levonorgestrel emergency professor emeritus of gynecology on tiered counseling, see “It’s time for contraceptive pills are approved for and obstetrics at Emory University a tiered approach to counseling on unrestricted sales on store shelves. School of Medicine in Atlanta, points emergency contraception,” CTU, March They include Plan B One-Step (Teva to the book Managing Contraception 2015, p. 29.) Women’s Health, North Wales, PA); 2015-2016, which summarizes the Take Action (Teva), Next Choice loss of effectiveness of emergency REFERENCES One Dose (Actavis, Parsippany, PA), contraceptive pills in overweight My Way (Gavis Pharmaceuticals, women with two concise statements: 1. Kapp N, Abitbol JL, Mathé H, et Somerset, NJ), Levonorgestrel 0.75 • “Emergency contraception with al. Effect of body weight and BMI

54 | CONTRACEPTIVE TECHNOLOGY UPDATE® / May 2015 on the efficacy of levonorgestrel 4. Glasier AF, Cameron ST, Fine PM, contraception. Contraception 2012; emergency contraception. et al. Ulipristal acetate versus 86:673-680. Contraception 2015; 91(2):97-104. levonorgestrel for emergency 7. Zieman M, Hatcher RA, Allen AZ. 2. Glasier A, Cameron ST, Blithe D, et contraception: A randomised non- Managing Contraception 2015- al. Can we identify women at risk of inferiority trial and meta-analysis. 2016. Atlanta: Bridging the Gap pregnancy despite using emergency Lancet 2010; 375:555-562. Communications; 2015. contraception? Data from 5. McDowell MA, Fryar CD, Ogden 8. Reproductive Health Access Project. randomized trials of ulipristal acetate CL, et al. Anthropometric reference Emergency contraception: Timing, and levonorgestrel. Contraception data for children and adults: United weight, and efficacy. November 2011; 84(4):363-367. States, 2003–2006. Hyattsville, MD: 2013. Accessed at http://bit. 3. Creinin MD, Schlaff W, Archer DF, et National Center for Health Statistics. ly/18GsqnV. al. receptor modulator Accessed at http://1.usa.gov/XnlZ7o. 9. Thompson K, Belden P. Counseling for emergency contraception. A 6. Moreau C, Trussell J. Results for emergency contraception: Time randomized controlled trial. Obstet from pooled Phase III studies of for a tiered approach. Contraception Gynecol 2006; 108(5):1089-1097. ulipristal acetate for emergency 2014; 90(6):559-561. n How to get the message across to young men about using condoms consistently and correctly hen used consistently and ages 15-19 was the highest reported — must decide the right fit and feel W correctly, latex condoms since 1995: 6.4 cases per 100,000. of , says Richard Crosby, are effective at preventing sexually Men ages 20-24 in 2013 had the PhD, endowed professor and chair of transmitted infections (STIs), highest rate since 1992: 27.7 cases per the College of Public Health at the including HIV. But are young men 100,000.1 University of Kentucky in Lexington. getting the information they need to Multiple types of condom-use There are too many types of condoms use condoms correctly? errors and problems are prevalent on the market today for men not to Young men especially need to among men at high risk of infection, experiment with them, says Crosby, hear the condom message. The most including “fit-and-feel” problems, a member of the Bloomington, recent national surveillance data from breakage, lost erection, and slippage.2 Indiana-based Kinsey Institute the Centers for Disease Control and What are key points for providers to Condom Use Research Team, an Prevention indicate that sexually mention when it comes to correct international research group. active adolescents and young adults application and proper lubrication? Much like trying on shoes, men are at increased risk for STIs when First, emphasize that men and should find the one type of condom compared to older adults.1 Consider their partners — whoever the that they like the best, the one that these statistics: partner may be, male or female makes them feel confident, secure, • In 2013, as in previous years, men ages 20-24 had the highest rate of (1,325.6 cases per EXECUTIVE SUMMARY 100,000 males) among all male age When used consistently and correctly, latex condoms are effective at groups. preventing sexually transmitted infections (STIs), including HIV . • Men ages 20-24 had the highest • The most recent national surveillance data indicate that sexually active rate of (459.4 cases per adolescents and young adults are at increased risk for STIs when compared 100,000 males) in 2013 among all to older adults . male age groups. During 2012–2013, • Multiple types of condom-use errors and problems are prevalent among the gonorrhea rate for men in this men at high risk of infection, including “fit-and-feel” problems, breakage, age group increased 1.3% over the lost erection, and slippage . previous year. • Proper counseling and provision of high-quality condoms and lubricants • In 2013, the rate of primary can help men and their partners have “better sex with latex ”. and secondary syphilis among men

54 | CONTRACEPTIVE TECHNOLOGY UPDATE® / May 2015 CONTRACEPTIVE TECHNOLOGY UPDATE® / May 2015 | 55 and at the same time, comfortable “Single-use lubrication vials effective, says Crosby. knowing that they are protected, should always be standard. Like a Crosby suggests using the phrase Crosby notes. “It shouldn’t feel like hamburger and fries at McDonald’s, “better sex with latex” to remind they are wearing something that is you wouldn’t order one without the patients that protected sex is sex awkward,” states Crosby. “It would be other,” notes Crosby. “When you’re that is free of worries about giving like wearing the wrong size shoe.” giving people condoms, allow them or getting an STI. Without those Remember that condoms come in to choose from an equal and high-end anxiety feelings, patients can magnify different materials, says Anita Nelson, supply of lubricants.” the overall experience so it is more MD, professor in the Obstetrics Recent studies have identified satisfying, focused, and less of a guilt and Gynecology Department at the a number of potential safety issues experience afterward. David Geffen School of Medicine with personal lubricants; data suggest Ask the patient, “Do you want at the University of California in that lubricants with high osmolality better sex?” says Crosby. This question Los Angeles. Polyisoprene condoms might cause vaginal and anal leads into a discussion about the (Durex RealFeel, RB plc, Slough, positive aspects of condom/lubricant Berkshire, England and LifeStyles use. By offering the patient a variety Skyn, Ansell Healthcare Products, “IT SHOULDN’T of quality condoms and lubricants Iselin, NJ) can help transmit body FEEL LIKE THEY for take-home use, it develops an heat while protecting against STIs, ongoing relationship with the patient. especially for latex-allergic couples, ARE WEARING This action turns the dynamic from she notes. SOMETHING “we don’t want to see you with Include partners in choice another STI” to “we want to see you THAT IS come back for refills on condoms and Equally important is that the AWKWARD . IT lubricants,” Crosby notes. selected condom be compatible with the fit and feel preferences of the WOULD BE LIKE REFERENCES sex partner, Crosby says. One style WEARING THE or make of condom might work 1. Centers for Disease Control and well with one partner, but the same WRONG SIZE Prevention. Sexually Transmitted condom might not be as good for SHOE ”. Disease Surveillance 2013. Atlanta: another partner, he notes. This search U.S. Department of Health and for the right fit and feel gives couples Human Services; 2014. a chance to talk about condom use, 2. Crosby R, Yarber WL, Sanders SA, et which in essence also leads to more epithelial damage.3 Until definitive al. Slips, breaks and “falls”: Condom condom use, says Crosby. answers are reached, refer to an errors and problems reported by “If they talk about condoms international technical advisory listing men attending an STD clinic. Int J before they have sex, they’re more on commercial lubricants (http://bit. STD AIDS 2008; 19(2):90-93. likely to actually use condoms during ly/1AdGZtB) to check osmolality of 3. World Health Organization, sex,” says Crosby. “It creates sort of a current options. Department of Reproductive Health built-in mechanism for the couple to There is no reason to spare the and Research, United Nations dialogue about safer sex, way before expense when it comes to buying Population Fund, Family Health they have it.” quality condoms and lubricants for International. Use and procurement Be sure to offer ample supplies clinic distribution, states Crosby. The of additional lubricants for male and of high-quality lubricants to men argument of “we can’t afford them” female condoms: WHO/UNFPA/ and women. There are now silicone does not hold up, he advocates. A FHI360. Accessed at http://bit. lubricants that last longer and feel 2011 estimate of costs for diagnosis ly/1AdGZtB. better than traditional water-based and treatment of chlamydia offered 4. Minnesota Chlamydia Partnership. lubricants, says Crosby. Lubricants figures of cost per case at $20 in The Minnesota chlamydia strategy: come in different sensations, males and $244 in females.4 Given Action plan to reduce and prevent viscosities, and scents, and they are those figures, providing high-quality chlamydia in Minnesota. Accessed at attractively packaged, says Crosby. condoms and lubricants is cost- http://bit.ly/1b0dKVd. n

56 | CONTRACEPTIVE TECHNOLOGY UPDATE® / May 2015 Counsel women on how to cope with menopause’s vasomotor symptoms

ew research indicates that established: total VMS duration, postmenopausal when symptoms N frequent vasomotor symptoms which measured the years elapsed began had the shortest total symptom (VMSs) associated with menopause between the first and last report duration (median, 3.4 years). Black could last more than seven years for of frequent vasomotor symptoms, women experienced the longest total many women.1 and post-final menstrual period, symptom duration (median, 10.1 The duration of vasomotor the number of years that frequent years); Japanese and Chinese women symptoms is an important question symptoms persisted after the final reported the shortest symptom for women in general and the period. Cessation of vasomotor duration (median, 4.8 years and 5.4 clinicians who treat them, says Nancy symptoms was defined as two years, respectively). The median total Avis, PhD, professor of public health consecutive visits without hormone symptom durations were 6.5 years for sciences/social sciences at Wake Forest replacement therapy or experiencing non-Hispanic white women and 8.9 Baptist Medical Center in Winston- symptoms. Researchers also sought years for Hispanic women.1 Salem, NC. to identify risk factors for the two Longer symptom duration “Women want to know how long measures. was associated with younger age, they can expect their hot flashes to Analysis indicates the median total lower educational level, history of last and whether it is unusual for duration of vasomotor symptoms at smoking, greater perceived stress, them to last a long time,” remarks 7.4 years. Among 881 women who greater sensitivity to symptoms, and Avis, who served as lead author of were aware of their final menstrual depression and anxiety at the time the current paper. “Up to now, we period, the median post-final of the first report of symptoms, have lacked good longitudinal data menstrual period persistence was 4.5 researchers report. Shorter symptom on this issue because it requires a long years.1 duration was observed among women period of follow-up of women going Timing of menopause emerged as with partners, higher educational through the menopausal transition; an important factor in the duration level, less financial pressure, and thus, clinicians have not been able of vasomotor symptoms, researchers greater social support.1 to provide women with very good report. The longest total vasomotor If women are at the beginning of information.” duration (median, more than 11.8 menopause, they might still be fertile, The Study of Women’s Health years) and post-final menstrual notes a commentary that accompanies Across the Nation (SWAN), a period persistence (median, 9.4 the current paper.2 If these women multiracial/multiethnic observational years) occurred among women experience frequent vasomotor study of women entering menopause, who were premenopausal or early symptoms, low-dose combined oral has been following women since 1996 perimenopausal when they first contraceptives might protect them and provides an ideal study in which experienced frequent vasomotor from pregnancy while tempering hot to address this question, says Avis. symptoms. Women who were flashes and night sweats, authors note. She and her coauthors analyzed data from 1,449 women with frequent EXECUTIVE SUMMARY vasomotor symptoms (defined as six or more affected days in the previous New research indicates that frequent vasomotor symptoms associated with two weeks). The research team is menopause could last more than seven years for many women . continuing to follow women in the • If women are at the beginning of menopause, they might still be fertile . SWAN study and might have even Low-dose combined oral contraceptives might offer pregnancy protection more information in a few years, Avis while tempering hot flashes and night sweats . notes. • Nonhormonal prescription treatments for managing vasomotor symptoms To conduct the current analysis, include use of selective serotonin-reuptake inhibitors and serotonin- researchers evaluated women at norepinephrine reuptake inhibitors . Nonprescription remedies include soy, a median of 13 visits during the isoflavone supplements, black cohosh, vitamin E, and yoga . study. Two primary outcomes were

56 | CONTRACEPTIVE TECHNOLOGY UPDATE® / May 2015 CONTRACEPTIVE TECHNOLOGY UPDATE® / May 2015 | 57 With a longer timeframe for each year, 36 million prescriptions risks than the combined therapy, menopause, some women might are written for Food and Drug but only women who have had a look to nonhormonal treatments for Administration-approved hormone should use managing vasomotor symptoms. The therapy. The remaining 28 to 39 alone. It appears that estrogen alone selective serotonin-reuptake inhibitors million prescriptions are likely for can be used safely for a longer time, (SSRIs) and serotonin-norepinephrine compounded hormones, the analysis says Gass. Because later analyses of reuptake inhibitors paroxetine, indicates.4 data indicated that older women escitalopram, venlafaxine, and If you think hot flashes taper off had more side effects from hormonal desvenlafaxine have been shown to be as a woman reaches age 52, the year therapy, the conclusion was that more effective than placebo for hot generally considered as the time of women should use hormone therapy flashes.3 Paroxetine 7.5 mg (Brisdelle, natural menopause, think again. in their early post-menopausal years Noven Therapeutics, Miami) is the Some 40% of women ages 60 to 65 when they are most symptomatic, only SSRI approved by the Food still have hot flashes, according to a then discontinue as soon as symptom and Drug Administration for this just-published study.5 relief is reached, notes Gass. indication.3 While these hot flashes are “Women need to know that they Nonprescription remedies such occasional and mild for many do still have options to treat their as soy, isoflavone supplements, black women, for some such symptoms hot flashes and sexual symptoms, cohosh, vitamin E, and omega-3 fatty remain troublesome, data indicate. even if they are older or cannot or do acids are generally low risk but with Women bothered by these symptoms not wish to use hormone therapy,” efficacy generally similar to placebo, often are not getting treatment, even says Gass. “NAMS encourages all notes a 2014 clinical guidance issued though treatments are available, women bothered by their menopause by the North American Menopause researchers report.5 symptoms to seek the help they need Society (NAMS).3 Most guidelines recommend and not to give up.” Menopausal hormone therapy against using systemic hormones REFERENCES is the most effective treatment for women more than 10 years for vasomotor symptoms, notes after menopause or after age 60 1. Avis NE, Crawford SL, Greendale the Society’s guidance. Options and to use them only for a limited G, et al. Duration of menopausal include systemic estrogen, estrogen- time ideally 3-5 years in the case vasomotor symptoms over the , estrogen-bazedoxifene, of combined estrogen/progestogen menopause transition. JAMA progestogen alone, or combined therapy. This recommendation is a Intern Med 2015; doi: 10.1001/ oral contraceptives in women change from the prescribing habits of jamainternmed.2014.8063. requiring contraception.3 Duavee, the 1990s, when there was widespread 2. Richard-Davis G, Manson JE. marketed by Wyeth Pharmaceuticals, use of hormone therapy for women Vasomotor symptom duration Philadelphia, a combination of the in all phases of menopause, says in midlife women — Research selective estrogen receptor modulator Margery Gass, MD, NAMS overturns dogma. JAMA bazedoxifene and conjugated executive director. Findings from Intern Med 2015; doi: 10.1001/ estrogen, is Food and Drug the Women’s Health Initiative study jamainternmed.2014.8099. Administration-approved for the changed such prescribing habits, with 3. Shifren JL, Gass ML; NAMS treatment of hot flashes. clinicians advised to prescribe only for Recommendations for Clinical Care According to the Society guidance, symptoms and for a limited time. of Midlife Women Working Group. custom-compounded bioidentical Estrogen therapy alone has fewer The North American Menopause hormones aren’t recommended because of lack of regulation, rigorous safety and efficacy testing, COMING IN FUTURE MONTHS batch standardization, and purity measures.3 Many women use „„Smartphone app aids „„Review options for treating compounded bioidentical hormones, condom distribution according to a recent analysis.4 Of „„Research progresses on „„Vaginal microbicide update the 57 to 75 million prescriptions for potential herpes vaccine — What’s the forecast? menopausal hormone therapies filled

58 | CONTRACEPTIVE TECHNOLOGY UPDATE® / May 2015 Society recommendations for clinical therapy: Identifying use trends and Moderate to severe vasomotor and care of midlife women. Menopause knowledge gaps among US women. sexual symptoms remain problematic 2014; 21(10):1038-1062. Menopause 2015; doi:10.1097/ for women aged 60 to 65 years. 4. Pinkerton JV, Santoro N. GME.0000000000000420. Menopause 2015; doi:10.1097/ Compounded bioidentical hormone 5. Gartoulla P, Worsley R, Bell RJ, et al. GME.0000000000000383. n Help young women transition to adult healthcare oung women ages 18 to 25 group.1 wort interferes with the efficacy of oral Y represent a heterogeneous During the visit, ask about the contraceptive pills. population transitioning from young woman’s living situation, Because injuries are the most adolescence into adulthood who including with whom she lives, how common preventable cause of might present with unique issues and well she gets along with others at morbidity and mortality among young challenges, including a potential gap home, and whether she feels safe women, safety questions are important in healthcare after pediatric healthcare. and secure. Questions about friends’ facets of the preventive visit. All The American College of Obstetrics high-risk behaviors such as alcohol patients should be asked about abuse, and Gynecology (ACOG) has just consumption and drug use can neglect, physical or sexual violence, released a committee opinion to make the patient more receptive to and reproductive coercion, such as help providers structure preventive answering questions about her own sabotage of contraceptive methods.1 healthcare visits to screen for health personal habits. Gold says she sees sleep disorders issues and counsel patients about a Assess a patient’s social support, in this age group, as young women variety of health topics, including says Melanie Gold, DO, MQT, are juggling multiple responsibilities reproductive health.1 DABMA, FAAP, FACOP, medical such as school, job, and family. Lack In 2011, the U.S. population was director of New York — Presbyterian of sleep can lead to increased risk of more than 311 million.2 Women ages Hospital’s School Based Health diabetes, weight gain, heart disease, 18-24 comprised 9.6% of the 158 Centers and adolescent medicine depression, driving accidents, and million U.S. females. This age group faculty at Columbia University mistakes at school or work.1(Use might need assistance in transitioning Medical Center in New York City. resources from the federal National from a pediatrician to a provider Identify who might be an advocate Institutes of Health’s National Heart, of adult healthcare, notes Julie for a young woman’s care, whether it Lung, and Blood Institute for additional Strickland, MD, chair of ACOG’s might be her mother, an aunt, or a information and resources on sleep. Visit Adolescent Health Care Committee, trusted friend, Gold says. http://1.usa.gov/1Evgg1W.) which issued the opinion. Talk with your patient about REFERENCES Young women in this age group whether she has any concerns or often have some gaps in medical care, questions about the shape or size of 1. Committee opinion no. 626: The Strickland observes. Often, they are her body or the way she looks, the transition from pediatric to adult newly on their own and don’t really guidance advises. Ask whether she health care: Preventive care for young know what provider to use to assess wants to gain or lose weight, and if women aged 18-26 years. Obstet their needs. Also, young women might she has ever tried to lose weight or Gynecol 2015; 125(3):752-754. feel well, so they don’t go for sick control her weight by vomiting, using 2. Department of Health and Human visits, but yet have a lot of screening diet pills or laxatives, or not eating for Services, Health Resources and needs, Strickland states. a day. Questions about intake of fruits Services Administration, Maternal Many young women come to and vegetables, calcium, multivitamin and Child Health Bureau. Women’s view their obstetrician-gynecologist with folic acid, iron, and dietary Health USA 2011. Rockville, MD: U.S. as their primary health provider.3 In a restrictions can help you understand Department of Health and Human preventive healthcare visit, providers dietary behaviors. Be sure to check use Services, 2011. should screen for health issues and of herbal and natural supplements, 3. Callahan ST, Cooper WO. Changes in counsel patients about a variety of because some supplements can ambulatory health care use during health topics, some of which are interfere with certain prescription the transition to young adulthood. J particularly relevant to their age medications; for example, St. John’s Adolesc Health 2010; 46:407-413. n

58 | CONTRACEPTIVE TECHNOLOGY UPDATE® / May 2015 CONTRACEPTIVE TECHNOLOGY UPDATE® / May 2015 | 59 CNE/CME INSTRUCTIONS

To earn credit for this activity, please follow these instructions: EDITORIAL ADVISORY BOARD 1. Read and study the activity, using the provided references for further research.

CHAIRMAN Robert A. Hatcher, MD, MPH 2. Scan the QR code to the right or log on to the AHCMedia.com site to take a post-test. Senior Author, Contraceptive Technology Go to “MyAHC” and then “My Courses” to view your available CE activities. Tests are taken Professor Emeritus of Gynecology and after each issue. First-time users will have to register on the site using the 8-digit subscriber Obstetrics, Emory University School of number on their mailing label, invoice, or renewal notice. Medicine, Atlanta 3. Pass the online tests with a score of 100%; you will be allowed David F. Archer, MD, Professor of OB/ to answer the questions as many times as needed to achieve a GYN, The Jones Institute for Reproductive score of 100%. Medicine, The Eastern Virginia Medical School, Norfolk 4. After successfully completing the test, your browser will be Kay Ball, RN, PhD, CNOR, FAAN automatically directed to the activity evaluation form, which you Perioperative Consultant/Educator will submit online. K&D Medical, Lewis Center, OH 5. Once the completed evaluation is received, a credit letter will Melanie Deal, MS, WHNP-BC, FNP, be e-mailed to you instantly. Nurse Practitioner, University Health Ser- vices , University of California, Berkeley Linda Dominguez, RNC, WHNP, Clinical Consultant, Southwest Women’s Health Albuquerque, NM CNE/CME QUESTIONS Andrew M. Kaunitz, MD, Professor & Associate Chairman, University of Florida Research Foundation Department of Obstetrics and Gynecology, University of Florida College of Medicine — Jacksonville 1. What is the labeled duration of weighing more than 75 kg, Anita L. Nelson, MD, Professor, OB-GYN David Geffen School of Medicine use for the LILETTA intrauterine levonorgestrel emergency University of California, Los Angeles device? contraceptives were minimally Wayne Shields, President & CEO, Associa- effective. What is the average tion of Reproductive Health Professionals A. Three years Washington, DC weight of the American B. Five years James Trussell, PhD, Professor of Eco- woman? nomics and Public Affairs Director, Office C. Seven years of Population Research, Princeton (NJ) D. 12 years A. 50 kg University B. 60 kg David Turok, MD, MPH, Associate Profes- sor, Department of Obstetrics and Gyne- 2. What is the labeled duration C. 75 kg cology, University of Utah, Salt Lake City of use for the Nexplanon D. 80 kg Susan Wysocki, WHNP-BC, FAANP, subdermal contraceptive? President & CEO, iWomansHealth Washington, DC 4. What is the selective serotonin- A. Three years reuptake inhibitor that is To reproduce any part of this newslet- B. Five years ter for promotional purposes, please approved for treatment of hot contact:. Stephen Vance. Phone: (800) C. Seven years flashes? 688-2421, ext. 5511. Email: stephen.vance@ D. 12 years ahcmedia.com. To obtain information and pricing on group discounts, multiple A. Escitalopram copies, site-licenses, or electronic dis- tribution please contact: Tria Kreutzer. 3. Study findings by Kapp N, et al B. Venlafaxine Phone: (800) 688-2421, ext. 5482. Email: [Contraception 2015; 91(2):97- C. Desvenlafaxine [email protected]. To reproduce any part of AHC newsletters for edu- 104] indicate that for women D. Paroxetine cational purposes, please contact The Copyright Clearance Center for permis- sion: Email: [email protected]. Website: www.copyright.com. Phone: (978) 750-8400 Contraceptive Technology Update is endorsed by the National Association of CNE/CME OBJECTIVES Nurse Practitioners in Women’s Health and the Association of Reproduc­tive Health After reading Contraceptive Technology Update, the participant will be able to: Profes­sionals as a vital information source 1. identify clinical, legal, or scientific issues related to development and provisions of for healthcare professionals. contraceptive technology or other reproductive services; 2. describe how those issues affect services and patient care; 3. integrate practical solutions to problems and information into daily practices, according to advice from nationally recognized experts; 4. provide practical information that is evidence-based to help clinicians deliver contraceptives sensitively and effectively.