The Investigational Nestorone®/Ethinyl Estradiol One-Year Vaginal Contraceptive System

Council researchers have developed a long-acting contraceptive vaginal system that has the potential to prevent pregnancy for one full year.

The Issue

While several contraceptive methods have been developed for short- and long-term protection against pregnancy, women’s needs differ and may change over the course of their lifetime. Having access to a variety of contraceptive options allows women to choose the method best suited to their needs.

In low-resource settings, women face unique barriers to obtaining effective contraception. A woman may encounter opposition from her family or community. Public-sector programs, the main source of contraception in most developing countries, typically offer limited options and supplies are not always available. Healthcare providers may not be trained or available to provide the counseling and services that women require in order to address their reproductive health needs. These factors leave women at risk for unintended pregnancy, unsafe abortion, and other health risks associated with pregnancy and childbirth.

The Progress

Population Council researchers have developed a one-year contraceptive vaginal ring, which—if approved by regulatory authorities—will be the first contraceptive to provide a full year of protection against unintended pregnancy while fully under a woman’s control. 

Two pivotal open-label safety and efficacy Phase 3 trials of the one-year ring were completed involving 2,308 healthy women at 27 sites in the United States, Latin America, Europe, and Australia. The women were between 18 and 40 years of age and were instructed to use the one-year ring over 13 menstrual cycles, or one full year.

Roughly 2 ¼ inches in diameter, the soft, flexible ring can be inserted and removed by the woman herself. In formulating the ring, Population Council researchers combined a widely used estrogen (ethinyl estradiol) with a new progestin (Nestorone®) to develop a single ring that can prevent ovulation for an entire year (13 cycles). During each cycle, the ring is left in place for 21 days and removed for 7 days. The one-year contraceptive ring does not require refrigeration, which is particularly important for distribution and use in low-resource settings.

Women in the Phase III trials of the new ring ranked it highly in terms of convenience, ease of use, and comfort. Nearly 9 in 10 women (89%) surveyed were satisfied with the ring as a method of contraception. Most participants surveyed found the ring easy to use and experienced no change in sexual pleasure or frequency when using the ring. The majority of women and their partners reported that they did not feel the ring when it was in place.

Efforts are underway to complete US Food and Drug Administration (FDA) review and to pursue regulatory approval in low and middle-income countries.

The Impact

The Population Council has developed and licensed some of the most widely used long-acting, reversible contraceptives in the world, including the Copper T intrauterine device; Mirena®, the levonorgestrel-releasing intrauterine system; and the implants Jadelle® and Norplant®. More than 170 million women worldwide are currently using contraceptive methods based on the Population Council’s technology. Council researchers continue to advance a rich pipeline of innovative options to meet the sexual and reproductive health needs of women, men and young people around the world. If approved, the vaginal contraceptive system would be the first contraceptive option that provides a full year of protection against unintended pregnancy while fully under a woman’s control.

Key Staff (6)

  • Régine Sitruk-Ware Distinguished Scientist, Center for Biomedical Research
  • Ruth Merkatz Director, Clinical Development, Center for Biomedical Research
  • George W. Creasy Medical Director, Center for Biomedical Research
  • Narender Kumar Senior Scientist, Center for Biomedical Research
  • Bruce Variano Senior Scientist, Head of Pharmaceutical Development, Center for Biomedical Research
  • Shweta Ugaonkar Senior Research Investigator, Center for Biomedical Research
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Journal Articles (6)

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Research Publications (1)