Executive Summary
An initial analysis of data conducted by Washington University School of Medicine in St. Louis indicates that hormonal intrauterine devices (IUDs) and contraceptive implants remain highly effective one year beyond their approved duration of use.
• The etonogestrel subdermal implant and the 52-mg levonorgestrel IUD represent two of the most effective forms of reversible contraception available with a failure rate of less than 1% over the respective three-year and five-year durations approved by the Food and Drug Administration.
• Study findings indicate the devices still are effective in different populations of users past their approved duration of use. This duration improves the cost-effectiveness of such devices and helps women avoid unnecessary removals/re-insertions, researchers state.
An initial analysis of data conducted by Washington University School of Medicine in St. Louis indicates that hormonal intrauterine devices (IUDs) and contraceptive implants remain highly effective one year beyond their approved duration of use.1
The etonogestrel subdermal implant (Nexplanon, Merck, Whitehouse Station, NJ) and the 52-mg levonorgestrel IUD (Mirena, Bayer Healthcare Pharmaceuticals, Wayne, NJ) represent two of the most effective forms of reversible contraception available with a failure rate of less than 1% over the respective three-year and five-year durations approved by the Food and Drug Administration. Data indicate both devices provide effective use past their approved durations. Three studies in which a total of 275 women used the etonogestrel implant Implanon for longer than three years found no pregnancies during the fourth year of use. A 2014 systematic review concluded that the 52-mg levonorgestrel IUD could be used safely for up to seven years.2,3
The Contraceptive CHOICE Project had an “amazing” uptake and continuation of long-acting reversible contraception (LARC) among its participants, says Colleen McNicholas, DO, MSCI, assistant professor in the Washington University School of Medicine’s Obstetrics and Gynecology Department. This level of participation has given researchers a unique opportunity to study a cohort of women using these methods for a longer time, McNicholas observes. The Contraceptive CHOICE Project was a prospective cohort study of reproductive-aged women in St. Louis designed to promote the use of LARC by eliminating cost, access, and knowledge barriers.
The present study, known as the Effectiveness of Prolonged use of the IUD and Implant for Contraception (EPIC) study, is seeking to fill gaps in the literature regarding extended use of the etonogestrel implant and 52-mg levonorgestrel IUD. It aims to enroll a total of 800 women. The currently published initial analysis included 237 women who used implants and 263 women who used hormonal IUDs.
“This study gives us an opportunity to show the devices are still effective, in different populations of users,” says McNicholas, who served as lead author of the current paper. “This improves the cost-effectiveness of the device and helps women avoid unnecessary removals/re-insertions.”
Review the research
Women participating in the EPIC analysis were ages 18 to 45, and their contraceptives had to be within six months of expiring when they enrolled. The women were informed of a possible risk of pregnancy if the devices were used beyond the duration of use approved by the Food and Drug Administration.
Unintended pregnancy rate per 100 women-years was calculated. To check serum etonogestrel levels, implant users were offered periodic venipuncture. The Kruskal-Wallis test, a form of statistical analysis, was used to compare the etonogestrel levels across body mass index (BMI) groups.
The researchers documented no pregnancies in the implant group and one pregnancy in the IUD group. This failure rate is similar to that of IUDs used within the recommended five-year window, researchers note.
Scientists will continue to follow the women and others who enroll in the study. The final results will determine if the 52-mg levonorgestrel IUD and the contraceptive implant are effective for up to three years beyond their approved duration of use.
It will be important to study the mechanism of action for the implant during its fourth year of use, says Anita Nelson, MD, professor in the Obstetrics and Gynecology Department at the David Geffen School of Medicine at the University of California in Los Angeles. Many turn to the implant because it so reliably suppresses ovulation, she says.
LARC is catching on
The use of LARC methods is catching on. Use of IUDs and implants jumped five-fold between 2002 and 2011, according to a new U.S. government report.4 Among women ages 15 to 44, the use of such long-term reversible contraceptives rose from 1.5% in 2002 to 7.2% in 2011-2013, according to the Centers for Disease Control and Prevention report. (For more on contraceptive use, see “Statistics show more use of LARC — How can you maintain momentum?” Contraceptive Technology Update, March 2015, p. 25.)
With more women moving to LARC methods, the continued follow-up of the EPIC study participants will provide data that might change the provision of contraceptive services. The potential to further improve the cost-effectiveness by extending the life of these devices could provide “tremendous” economic benefit to insurers and to society, researchers state.
“The longer a contraceptive method is effective, the bigger the impact it can have,” said co-author Jeffrey Peipert, MD, PhD, the Robert J. Terry Professor of Obstetrics and Gynecology at Washington University School of Medicine in St. Louis. “In the long term, this work has the potential to change how we provide contraceptive methods around the world and can enable women to control their reproductive health and family size.”
REFERENCES
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McNicholas C, Maddipati R, Zhao Q, et al. Use of the etonogestrel implant and levonorgestrel intrauterine device beyond the U.S. Food and Drug Administration-approved duration. Obstet Gynecol 2015; 125(3):599-604.
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Raymond EG. Contraceptive implants. In: Hatcher RA, Trussell J, Nelson AL, et al. Contraceptive Technology: 20th revised edition. New York: Ardent Media; 2011.
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Wu JP, Pickle S. Extended use of the intrauterine device: A literature review and recommendations for clinical practice. Contraception 2014; 89:495-503.
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Daniels K, Daugherty J, Jones J. Current contraceptive status among women aged 15-44: United States, 2011–2013. NCHS data brief, no 173. Hyattsville, MD: National Center for Health Statistics. 2014.
