New Population Council research presented at 13th ESC Annual Congress

(Press-News.org) LISBON, PORTUGAL (31 May 2014) – This week, the Population Council presented new research at the 13th Congress of the European Society of Contraception and Reproductive Health. Presentations included a pharmacokinetic analysis of the Council's investigational one-year contraceptive vaginal ring containing Nestorone® and ethinyl estradiol, and its investigational male contraceptive implant MENT®, as well as new approaches to "green contraception," including strategies to ensure that future contraceptive technologies are both effective and protect the environment.

"The Population Council helped establish the field of long-acting, reversible contraception, and we are pleased to share new research at the 13th Congress of the European Society of Contraception and Reproductive Health," said Dr. Régine Sitruk-Ware, Distinguished Scientist at the Population Council's Center for Biomedical Research. "In a world where millions of men and women lack access to family planning information and services, the need for new contraceptive options has never been more urgent."

Research Highlights

Male Contraception Male contraceptive options are limited to the condom and vasectomy. Scientists at the Population Council and elsewhere are developing new technologies that induce reversible infertility through hormonal and non-hormonal methods. During a session titled, "Is there a future for male contraception?" Sitruk-Ware, discussed some of the most promising male contraceptives under development.

Identifying molecules that block proteins or enzymes that regulate the function of sperm cells is critical to the development of male contraceptives. Sitruk-Ware also noted the importance of identifying behavioral indicators that could predict acceptability and successful use of safe, effective, and reversible male contraceptives.

Sitruk-Ware stated that developing a hormonal contraceptive that is effective, safe, acceptable, long-acting, and reversible requires reducing sperm count without requiring frequent administration (e.g., daily use). The Council has been evaluating the safety and efficacy of the investigational product MENT, an implant that may inhibit sperm production without affecting prostate growth. Early studies showed promising results in the ability of MENT to inhibit sperm production, and research is ongoing to confirm these findings.

Council researchers are also studying a combined transdermal Nestorone (a synthetic hormone) and testosterone gel. In early studies, the gel demonstrated efficacy in reducing sperm count in men. Additionally, the Council continues to study the biology of sperm cells to ascertain how easy-to-administer technologies can prevent sperm from reaching and fertilizing an egg, and product candidates are being prepared for a late-stage clinical study.

Green Contraception "Green contraception" refers to any family planning method that minimizes environmental impact. This could mean methods that do not use hormones; that implement green standards in their manufacturing, packaging, and transport; and those whose waste and disposal have a minimal environmental impact.

In a session chaired by Sitruk-Ware, Dr. Diana Blithe of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) discussed the development of a "green score" for contraceptive products. Such a standardized scale would help researchers and product developers understand the environmental implications of contraceptive products. A green score that incorporates the elements of effectiveness and satisfaction as well as the environmental impact of production and use of the product may be an incentive to manufacturers, suppliers, and users to encourage improvements in their methods or use.

During the session, researchers discussed the role of multipurpose prevention technologies (MPTs) in meeting multiple sexual and reproductive health needs; as well as DMAU (dimethandrolone undecanoate), a synthetic androgen for male contraception.

Exploring the Role of MPTs as a "Green" Technology Part of this session presented by Dr. Judy Manning from USAID provided an overview of the public health rationale for MPTs and summarized efforts to prioritize MPTs in the product pipeline. With the potential to simultaneously prevent unintended pregnancy, HIV, and other sexually transmitted infections (STIs), MPTs could contribute to the concept of "green" contraception by meeting multiple sexual and reproductive health needs in a single product; achieving cost-efficiencies through service delivery; and using existing delivery systems to achieve higher levels of product demand and use.

The Potential of DMAU as a Green Contraceptive Dr. Christina Wang from UCLA used the example of DMAU to explore how the principle of green contraception could be applied to the development of new male contraceptives.

Researchers hypothesized that DMAU can be used as a single agent for male contraception while reducing the amount of steroids released into the body and the environment. Researchers are exploring the viability of formulating DMAU in oil or self-emulsifying delivery systems to enhance absorption (and optimize efficacy), while ideally reducing steroid waste.

Continuing Studies on the One-Year Investigational Contraceptive Vaginal Ring In an oral presentation, "User-controlled long-acting reversible contraception: The pharmacokinetic profile of the Nestorone and ethinyl estradiol contraceptive vaginal ring (NES/EE CVR), a 1-year cyclical re-usable vaginal ring," Dr. George Creasy, medical director at the Council's Center for Biomedical Research, explained how the one-year investigational contraceptive vaginal ring (the NES/EE CVR) delivers effective hormone levels to prevent pregnancy for one full year (13 cycles).

Thirty-nine women were enrolled in the open-label, non-randomized study in the Dominican Republic, Chile, and the United States. Researchers evaluated serum Nestorone and ethinyl estradiol concentrations in order to carefully evaluate the pharmacokinetic profile.

According to evaluations of hormonal concentrations taken during routine blood tests, the researchers stated that the ring effectively delivered contraceptive levels of Nestorone and ethinyl estradiol throughout the full 13-cycle period where women inserted the ring for 21 days and then removed it for 7 days to allow for a monthly withdrawal bleed. The efficacy results remained consistent with those of other marketed combined hormonal contraceptive methods.

In another oral presentation titled, "Effects of a one-year reusable contraceptive vaginal ring on vaginal flora and vaginal infection: A prospective evaluation," Dr. Ruth Merkatz, director of clinical development for the Council's Center for Biomedical Research, presented results from a microbiology study demonstrating that using the NES/EE CVR cyclically over one year is not associated with an increased risk of vaginal infections. The study included 120 women participating in a Phase 3 safety and efficacy trial of the NES/EE CVR over 13 cycles.

INFORMATION: 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 contact Sasha Gruber, Communications Manager Population Council: email: sgruber@popcouncil.org, phone: +1 212 339 0668