A new woman-controlled contraceptive vaginal ring: a global step forward
Authors: Marleen Temmerman
Journal: The Lancet Global Health (2019)

More than 40 years ago, the development of contraceptive vaginal rings began, based on the fact that the vaginal epithelium can absorb steroid hormones and the capacity of elastomers to release these hormones at almost constant rates.1Mishell Jr, DR Lumkin ME Contraceptive effect of varying dosages of progestogen in silastic vaginal rings.Fertil Steril. 1970; 21: 99-103Summary Full Text PDF PubMed Google Scholar The growing interest in woman-controlled contraceptive methods has supported and accelerated the process. The main advantages of contraceptive vaginal rings are their effectiveness, ease of use, user control, nearly constant release rate allowing for lower doses of hormones, greater bioavailability, and good cycle control compared with oral contraceptives.2Brache V Payán LJ Faundes A Current status of contraceptive vaginal rings.Contraception. 2013; 87: 264-272Summary Full Text Full Text PDF PubMed Scopus (59) Google Scholar There are two types of contraceptive vaginal ring on the market—Nuvaring (Merck Sharp & Dohme; Kenilworth, NJ, USA), which releases etonogestrel and ethinylestradiol for 1 month, and Progering (Silesia; Santiago, Chile), which is a 3-month progesterone-only ring for use during breastfeeding. Both rings are expensive, require refrigeration, and are not readily available in low-income and middle-income countries (LMICs). Therefore, reducing costs and expanding the availability of contraceptive vaginal rings is important, as is development of those with longer durations that do not need refrigeration, which would increase the contraceptive options for women globally. In The Lancet Global Health, David Archer and colleagues3Archer DF Merkatz RB Bahamondes L et al.Efficacy of the 1-year (13-cycle) segesterone acetate and ethinylestradiol contraceptive vaginal system: results of two multicentre, open-label, single-arm, phase 3 trials.Lancet Glob Health. 2019; published online June 20. http://dx.doi.org/10.1016/S2214-109X(19)30265-7Scopus (31) Google Scholar report the results of two non-randomised, open-label, single-arm phase 3 trials of a ring-shaped, contraceptive vaginal system developed by the Population Council, which releases a consistent amount of segesterone acetate and ethinylestradiol over 1 year of cyclic use and does not require refrigeration. These trials were done at US and non-US sites and evaluated the efficacy of the contraceptive vaginal system and return to menses or pregnancy after use.3Archer DF Merkatz RB Bahamondes L et al.Efficacy of the 1-year (13-cycle) segesterone acetate and ethinylestradiol contraceptive vaginal system: results of two multicentre, open-label, single-arm, phase 3 trials.Lancet Glob Health. 2019; published online June 20. http://dx.doi.org/10.1016/S2214-109X(19)30265-7Scopus (31) Google Scholar The results showed the efficacy and safety of this contraceptive system, with an overall Pearl Index of 2·98 (95% CI 2·13–4·06) and a contraceptive efficacy rate of 97·5% on the basis of a life-table analysis. All participants who were followed up reported return to menses or pregnancy within 6 months. As this contraceptive vaginal system is effective for a full year of cyclic use and does not require refrigeration during periods of non-use, this is likely to facilitate accessibility and help to address a global unmet contraceptive need.3Archer DF Merkatz RB Bahamondes L et al.Efficacy of the 1-year (13-cycle) segesterone acetate and ethinylestradiol contraceptive vaginal system: results of two multicentre, open-label, single-arm, phase 3 trials.Lancet Glob Health. 2019; published online June 20. http://dx.doi.org/10.1016/S2214-109X(19)30265-7Scopus (31) Google Scholar Gemzel-Danielson and colleagues4Gemzell-Danielsson K Sitruk-Ware R Creinin MD et al.Segesterone acetate/ethinyl estradiol 12-month contraceptive vaginal system safety evaluation.Contraception. 2019; 99: 323-328Summary Full Text Full Text PDF PubMed Scopus (24) Google Scholar reported that the 1-year segesterone acetate 150 μg and ethinylestradiol 13 μg daily contraceptive vaginal system represents a new long-term, user-controlled, and procedure-free contraceptive option with a safety profile similar to other combined hormonal contraceptives.4Gemzell-Danielsson K Sitruk-Ware R Creinin MD et al.Segesterone acetate/ethinyl estradiol 12-month contraceptive vaginal system safety evaluation.Contraception. 2019; 99: 323-328Summary Full Text Full Text PDF PubMed Scopus (24) Google Scholar The new contraceptive vaginal system is a safe and effective combined hormonal contraceptive that is under a woman's control and was considered acceptable by women who participated in the clinical trials.3Archer DF Merkatz RB Bahamondes L et al.Efficacy of the 1-year (13-cycle) segesterone acetate and ethinylestradiol contraceptive vaginal system: results of two multicentre, open-label, single-arm, phase 3 trials.Lancet Glob Health. 2019; published online June 20. http://dx.doi.org/10.1016/S2214-109X(19)30265-7Scopus (31) Google Scholar Addressing the unmet contraceptive need remains a global high priority, as illustrated by recent reports assessing progress in meeting contraceptive demands since the Family Planning 2020 Summit.5Cahill N Sonneveldt E Stover J et al.Modern contraceptive use, unmet need, and demand satisfied among women of reproductive age who are married or in a union in the focus countries of the Family Planning 2020 initiative: a systematic analysis using the Family Planning Estimation Tool.Lancet. 2018; 391: 870-882Summary Full Text Full Text PDF PubMed Scopus (81) Google Scholar, 6Ahmed S Choi Y Rimon JG et al.Trends in contraceptive prevalence rates in sub-Saharan Africa since the 2012 London Summit on Family Planning: results from repeated cross-sectional surveys.Lancet Glob Health. 2019; 7: e904-e911Summary Full Text Full Text PDF PubMed Scopus (43) Google Scholar Cahill and colleagues5Cahill N Sonneveldt E Stover J et al.Modern contraceptive use, unmet need, and demand satisfied among women of reproductive age who are married or in a union in the focus countries of the Family Planning 2020 initiative: a systematic analysis using the Family Planning Estimation Tool.Lancet. 2018; 391: 870-882Summary Full Text Full Text PDF PubMed Scopus (81) Google Scholar reported that between 2012 and 2017 the number of women of reproductive age who were married or in a union and using modern methods of contraception increased by 28·8 million, with success stories including rapid increases in use in Kenya, Mozambique, Malawi, Lesotho, Sierra Leone, Liberia, and Chad relative to what was expected in 2012. However, they also underlined that global levels of contraceptive prevalence mask the diversity in progress at the country level.5Cahill N Sonneveldt E Stover J et al.Modern contraceptive use, unmet need, and demand satisfied among women of reproductive age who are married or in a union in the focus countries of the Family Planning 2020 initiative: a systematic analysis using the Family Planning Estimation Tool.Lancet. 2018; 391: 870-882Summary Full Text Full Text PDF PubMed Scopus (81) Google Scholar Ahmed and colleagues6Ahmed S Choi Y Rimon JG et al.Trends in contraceptive prevalence rates in sub-Saharan Africa since the 2012 London Summit on Family Planning: results from repeated cross-sectional surveys.Lancet Glob Health. 2019; 7: e904-e911Summary Full Text Full Text PDF PubMed Scopus (43) Google Scholar showed that annual percentage increases in contraceptive use were above the average of 1·4 percentage points needed to achieve the 2012 Family Planning Summit goal to provide family planning to an additional 120 million women by 2020.6Ahmed S Choi Y Rimon JG et al.Trends in contraceptive prevalence rates in sub-Saharan Africa since the 2012 London Summit on Family Planning: results from repeated cross-sectional surveys.Lancet Glob Health. 2019; 7: e904-e911Summary Full Text Full Text PDF PubMed Scopus (43) Google Scholar, 7Brown W Druce N Bunting J et al.Developing the "120 by 20" goal for the Global FP2020 Initiative.Stud Fam Plann. 2014; 45: 73-84Crossref PubMed Scopus (76) Google Scholar However, progress was shown to be slow in several countries where the annual rate of change was lower than 1 percentage point, far below the target needed to achieve the goal.6Ahmed S Choi Y Rimon JG et al.Trends in contraceptive prevalence rates in sub-Saharan Africa since the 2012 London Summit on Family Planning: results from repeated cross-sectional surveys.Lancet Glob Health. 2019; 7: e904-e911Summary Full Text Full Text PDF PubMed Scopus (43) Google Scholar Multiple factors play a part in contraceptive use and need to be addressed. Availability and affordability of a portfolio of modern contraceptive methods, including this new birth control option, might help address the persistent, unmet, global contraceptive need. This new contraceptive vaginal ring was approved by the US Food and Drug Administration in August, 2018, and thus represents the first ring not requiring refrigeration to offer women a whole year of contraceptive protection, contributing to equity and choice.8US Food and Drug AdministrationDrug Approval Package: Annovera (segesterone acetate and ethinyl estradiol).https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209627Orig1s000TOC.cfmDate accessed: June 13, 2019Google Scholar I declare no competing interests. Efficacy of the 1-year (13-cycle) segesterone acetate and ethinylestradiol contraceptive vaginal system: results of two multicentre, open-label, single-arm, phase 3 trialsThe segesterone acetate and ethinylestradiol contraceptive vaginal system is an effective contraceptive for 13 consecutive cycles of use. This new product adds to the contraceptive method mix and the 1-year duration of use means that women do not need to return to the clinic or pharmacy for refills every few months. Full-Text PDF Open AccessSRHR: unmet needs and unfinished agendasThere is something fascinating about looking at the world through the population lens. Last month, the UN released the 2019 World Population Prospects —a dizzying display of how and where humanity is expanding, contracting, and moving. World Population Day, on July 11, is an opportunity to reflect on these demographic megatrends and the substantial effects they can have on economic and social development. According to the report, humanity will reach 10 billion in 2050; the Indian population will exceed that of China around 2027; international migration is a steady component of population change; worldwide the over-65s outnumber the under-5s for the first time in history; and reductions in fertility in Asia, Latin America and the Caribbean, and even Africa, are providing unprecedented opportunities for economic growth as working-age adults become the largest population group. Full-Text PDF Open Access