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Credit: Population Council
NEW YORK (December 9, 2013) – The Population Council was awarded a cooperative agreement from the U.S. Agency for International Development's (USAID) Office of Population and Reproductive Health, "Delivering a Family of Contraceptive Vaginal Rings." Included in this agreement is support for two innovative, Population Council-developed contraceptive vaginal rings: a one-year contraceptive vaginal ring that can be used by women to plan their pregnancies and a three-month vaginal ring that can be used by breastfeeding women.
The project will facilitate final development, regulatory review, and introduction of the one-year contraceptive vaginal ring containing Nestorone® and ethinyl estradiol in USAID-priority countries. It will expand availability and increase affordability of the three-month Progesterone Vaginal Ring (PVR) in developing markets for postpartum breastfeeding women.
The project will also build collaboration with commercial outlets, social marketing providers, and not-for-profit providers to ensure broad availability of and access to the methods. The Council will lead the initiative and will work with a consortium that includes WomanCare Global, Andrómaco, and QPharma. Dr. John W. Townsend will be the principal investigator (PI), and Dr. Ruth Merkatz and Dr. Saumya RamaRao will be the co-PIs from the Population Council.
"The Council is proud to partner with USAID and distinguished colleagues on introducing a new line of contraceptive vaginal rings where access to safe, effective, and affordable new methods are limited or nonexistent," said John W. Townsend, Ph.D., Vice President of the Population Council's Reproductive Health Program. "The introduction of these methods will provide new options to address unmet needs for women around the world."
Long-acting vaginal rings represent an important advancement in contraceptive development. These methods are especially beneficial for women in low-resource settings as they are designed to be under the woman's control and do not require insertion by a healthcare provider or regular visits to a pharmacy.
About the PVR
The three-month PVR for breastfeeding women is an effective, user-controlled method that can be used safely by breastfeeding women to aid in spacing pregnancies. It does not affect a woman's ability to produce breast milk and does not require insertion by a healthcare provider. Each ring can be used continuously for three months, and rings can be used successively for up to one year. Fertility returns shortly after discontinuing use.
The three-month PVR for breastfeeding women is currently approved for use in eight countries in Latin America. The Council is working to introduce the PVR in more countries where prolonged lactation is vital for infant health. Currently, nursing women in sub-Saharan Africa who wish to delay another pregnancy have limited access to highly effective contraceptive options. The Council is working toward product introduction in Kenya, Nigeria, and Senegal, as well as in India, with the goal of expanding to other countries if the results are favorable.
The project will also engage representatives from communities of potential consumers and providers in decision-making related to country adoption of the PVR and the one-year ring.
About the One-Year Contraceptive Vaginal Ring
The one-year contraceptive vaginal ring releases a low dose of hormones to suppress ovulation and thereby prevent pregnancy. It is left in place for 21 days and removed for seven days. One ring can be used for up to 13 cycles (one year). The ring contains ethinyl estradiol, an approved, marketed hormonal product, and Nestorone®, an investigational progestin that has been shown to be highly effective in preventing ovulation.
Because it is intended to be effective for 13 cycles and does not require refrigeration, the one-year contraceptive vaginal ring may be an attractive option for women in developing countries who lack convenient access to a healthcare facility or pharmacy, and where access to reliable electricity is a challenge.
The Council is preparing to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and will seek to introduce the one-year contraceptive vaginal ring to USAID priority countries.
About the Population Council
The Population Council confronts critical health and development issues—from stopping the spread of HIV to improving reproductive health and ensuring that young people lead full and productive lives. Through biomedical, social science, and public health research in 50 countries, we work with our partners to deliver solutions that lead to more effective policies, programs, and technologies that improve lives around the world. Established in 1952 and headquartered in New York, the Council is a nongovernmental, nonprofit organization governed by an international board of trustees.
Media and Project Contacts
Media: Sasha Gruber: sgruber@popcouncil.org; +1 212-339-0668
Project: John Townsend: jtownsend@popcouncil.org; +1 202 237 9400