Project

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

Council researchers have developed a long-acting, reversible contraceptive vaginal ring that can 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 long-acting, reversible contraceptive under a woman’s control. This one-year ring contains Nestorone® (NES—an investigational new chemical entity) and ethinyl estradiol (EE), an approved, marketed hormonal product.

Two pivotal open-label safety and efficacy Phase 3 trials of the one-year ring were completed involving approximately 2,270 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 on using the one-year ring over 13 menstrual cycles, or one full year.

Study results suggest the one-year ring is effective in preventing pregnancy when used as directed, and that its safety profile is similar to that of other marketed hormonal contraceptives. The ring is also well-accepted by women and their partners. The vast majority of women in the trials reported being satisfied or very satisfied with this novel form of contraception. Roughly 2 ¼ inches in diameter, the ring is soft, flexible, and easily inserted into the vagina by the woman herself—and does not have to be inserted by a trained healthcare provider. It is left in place for 21 days and removed for seven days, for up to 13 cycles. Once in place, the ring prevents ovulation by continuously releasing a low dose of hormones through the vaginal walls and into the bloodstream. The hormones keep an egg from being released from the ovary to prevent fertilization.

Because the ring is effective for one year and does not require refrigeration prior to distribution or during periods of non-use, it may be an attractive option for women in low-resource settings who lack convenient access to a healthcare facility or a pharmacy, and in areas where access to electricity to ensure constant refrigeration may be unreliable.

Efforts are underway to prepare and submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) and to pursue regulatory approval in low and middle-income countries.

The Impact

The Council is dedicated to developing and expanding access to contraceptive technologies to regions of the world where safe, effective, and convenient family planning services are scarce or nonexistent. If approved by regulatory authorities, the one-year ring would be a unique contraceptive that is effective for 13 cycles, is under the woman’s control, and does not require insertion or removal by a trained healthcare professional.

Experts (7)

  • 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
  • Bruce Variano Senior Scientist, Head of Pharmaceutical Development, Center for Biomedical Research
  • Narender Kumar Senior Scientist, Center for Biomedical Research
  • Kyle Kleinbeck Senior Research Investigator, Center for Biomedical Research
  • Shweta Ugaonkar Senior Research Investigator, Center for Biomedical Research
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Resources (4)