Amphora™ Selected by CDC for Microbicide Clinical Trial in Madagascar
Thursday, December 1st, 2005
Amphora™ Selected for Microbicide Clinical Trial
Madagascar Formative Study to Evaluate
Amphora’s Acceptability among High-risk Women
La Jolla, CA (December 1, 2005) – Amphora™ (clinically known as Acidform) was selected by the U.S. Centers for Disease Control and Prevention (CDC), the United States Agency for International Development (USAID), the Contraceptive Research and Development (CONRAD), and the University of North Carolina at Chapel Hill (UNC-CH) to be used in a formative research study, which began in October 2005 in Madagascar to test its acceptance by urban women at high risk for sexually transmitted infections (STI).
This study is the precursor to a 2006 trial that will evaluate effectiveness of the product from women’s health company Instead Inc. in preventing Neisseria gonorrhoeae and Chlamydia trachomatis infections in women. Pregnancy also will be monitored.
With previous studies showing fewer than 15 percent of high-risk women in one of the study’s participating cities reporting condom use during their last sexual act, and less than 10 percent of men in rural Madagascar reporting condom use over a three-month period, the CDC, in partnership with CONRAD, USAID, and UNC-CH, is seeking more prevention alternatives. Gauging acceptability among women and men is key in determining the potential of candidate microbicides like Amphora, according to Instead vice president and general manager Teri Hirschfeld.
“Heretofore, women have had to negotiate condom use with a partner, ” Hirschfeld said. “UNC-CH has already successfully tested acceptance of diaphragms, which can often be inconspicuous to men, among this study’s population of women. We’re pleased and honored to have been chosen as the candidate microbicide for this next stage of testing.”
Amphora was granted clearance by the U.S. Food and Drug Administration (FDA) to be marketed as a personal lubricant in late 2004. In addition to its lubricating properties, it has been shown, in early clinical and pre-clinical tests, to immobilize sperm for up to eight hours when applied vaginally by women. Preclinical testing has also shown it to inactivate several STI-causing organisms, including gonococci, herpes, chlamydia and HIV.
The formative study will be conducted by the University of North Carolina’s School of Public Health in collaboration with Madagascar’s National Institute of Public and Community Health and the Institute Pasteur in Madagascar. It is funded by the CDC through an Inter-Agency Agreement with USAID and CONRAD.
The U.S.-based principal investigator is Wilfrida (Frieda) Behets, Ph.D., Associate Professor of Epidemiology at the UNC-CH School of Public Health. Denise Jamieson, M.D., MPH is the CDC principal investigator for the study and is a Medical Officer at CDC.
Hirschfeld said while Amphora is being tested in Madagascar with the diaphragm as a cervical barrier device, Instead is also pursuing studies of their own contraceptive device utilizing Amphora. “We are finalizing test plans combining Amphora with a version of our Instead® Softcup®, which is currently on the market as a feminine hygiene product,” she explained. “This combination could provide women with a safe and discreet over-the-counter barrier contraceptive that they could control.”
Amphora is a bio-adhesive “acid-buffering” gel that coats the vaginal wall and cervix to help maintain a woman’s natural pH level between 3.8 and 4.2. It is also compatible with latex and polyurethane condoms. Originally developed by the Topical Prevention of Conception and Disease (TOPCAD) Program, Amphora was licensed to Instead in 2002, and patent protection was granted in March 2004.
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About Instead, Inc.
Instead, Inc. provides women with new and different choices for greater freedom and control of their reproductive and sexual health. The San Diego-based company is dedicated to offering women better options in health care segments where their needs are underserved with products that are thoroughly tested for safety and efficacy. Instead has focused research and development efforts on period protection and feminine hygiene, contraception, prevention of sexually transmitted infections including HIV/AIDS, and other conditions where vaginal therapy can be an effective preventative or treatment. More information about Instead and its products is online at www.softcup.com or www.amphoragel.com.
