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CONRAD Presents Results Of Pivotal Contraceptive Study At Reproductive Health 2011

September 16, 2011

Single-size diaphragm expands women’s protection options

CONRAD, a leading reproductive health research organization, will announce results of the SILCS Diaphragm contraceptive effectiveness study September 17th at the Reproductive Health 2011 Conference in Las Vegas, Nevada. The two-year study of 450 U.S. women implemented at six clinical sites in the U.S. showed that effectiveness rates of the new single size, contoured diaphragm are similar to traditional diaphragms. In addition, SILCS was shown to be easy to use and comfortable to wear. The single-size design eliminates the need for a fitting, which should reduce the amount of time required to provide this method, and opens the potential for providing the method outside of a clinic setting in the future, if allowed by regulatory authorities.

Jill Schwartz, M.D., CONRAD’s medical director and study principal investigator said, “Women and societies worldwide suffer from the consequences of unintended pregnancies. By expanding their contraceptive options with easy-to-use methods that have minimal side effects, we’re also expanding the potential for women’s overall health, not to mention, their families welfare.” She added, “Study participants reported high marks for ease of use and comfort for both women and their partners, which is so important–the only methods that work are the kind that women will actually use.”

The SILCS Diaphragm was developed at PATH, an international nonprofit organization whose mission is to improve the health of people around the world, and validated in collaboration with researchers at CONRAD. Development of the SILCS Diaphragm involved a user-centered design process incorporating input from women, their partners, and providers. This feedback led to an innovative design that is comfortable and easy to use–even for women with no previous diaphragm experience. The SILCS device was developed to improve reproductive health in low-resource settings, where women have a limited range of contraceptive methods and where diaphragms are not currently available.

This new diaphragm may also be important for women in developed countries, particularly for women who cannot or do not want to use hormonal methods or an IUD.

PATH’s Vice President and Senior Advisor for Technologies, Dr. Michael Free said, “High rates of unintended pregnancy and discontinuation of current contraceptive methods suggest that existing contraceptive methods do not adequately meet the reproductive health needs of all women. This newly designed, discreet, and reusable cervical barrier could expand women’s options for nonhormonal protection, thereby improving women’s reproductive health especially in low resource settings.”

Michael Thomas, M.D., ARHP Board Chair added, “The Association of Reproductive Health Professionals (ARHP) is honored that CONRAD and PATH have decided to release this pivotal new data at our Reproductive Health 2011 Conference. ARHP is committed to advancing multipurpose prevention technologies and is very excited by the promising developments coming out of the SILCS study.”

Funding support was provided by the U.S. Agency for International Development (USAID) and the Bill & Melinda Gates Foundation. Kessel Marketing & Vertriebs GmbH of Frankfurt, Germany, will be manufacturing the SILCS Diaphragm under license from PATH. Kessel and CONRAD are preparing regulatory applications for Europe and the United States. Regulatory approval as a nonprescription device will be determined on a country-by-country basis according to the local norms and guidelines. Through a phased approach, the product will be introduced at an affordable price in both developed and developing countries.

The development of the new device was a response to women calling for a broader choice of contraceptive methods that are under their control, can be easily stopped and started, and nonhormonal, thus eliminating side effects. The diaphragm is also more discreet than a male or female condom and less disruptive of spontaneity. Studies will continue to research its potential as a dual protection method by serving as a delivery device for a microbicide gel that can prevent HIV infection.

CONRAD has been developing new methods of contraception for men and women for 25 years. This includes both hormonal methods as well as barrier devices such as the female condom and cervical caps. CONRAD is spearheading regulatory work toward registration of tenofovir gel, the first vaginal microbicide proven to reduce HIV and herpes infection.

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