Amphora, produced by Evofem Inc., was approved by the FDA in 2004 for use as a personal lubricant. In early testing Amphora, which is non-hormonal, showed promise as a contraceptive gel through its ability to immobilize sperm and to prevent certain sexually transmitted infections.
Amphora currently is being tested in the largest global contraceptive clinical trial, which began in April 2011 and will be completed in 2014.
Amphora works as a contraceptive by maintaining a low vaginal pH that creates a hostile environment to sperm.
Amphora uses lactic acid to maintain the acidic pH in the vagina, which inhibits the sperm, preventing conception. Contraception is achieved without the use of other chemicals such as nonoxynol-9, hormones or latex products.
The three-year clinical trial will compare the effectiveness of Amphora with FDA-approved Conceptrol that contains nonoxynol-9, its active ingredient.
Saundra Pelletier, CEO of both Evofem and WomanCare Global a nonprofit organization, explained that while spermicides give women non-hormonal pre-coital control, nonoxynol- 9 has been banned in many settings because it may lead to increased risk of acquiring STIs or HIV.
When asked why Evofem set out to develop a new type of contraceptive, Pelletier responded, “Evofem is not just a bio-tech company, but a company that has a vision for how to improve women's lives. We looked at the currently available methods for family planning and saw a real gap.”
She went on to say, “This is particularly true in third world countries where women cannot control their partners. So we listened to women's demands and came up with a product we think will play a vital role in women's sexual health.”
The clinical trial has 3,200 women enrolled with participants from Russia and the United States of various ethnicities. The main targeted group is aged 18-35 and there is a subset group that is 35-45.
In the current trial, women use Amphora at least one hour before sex. The results from the study will be evaluated establishing a longer usage window.
Pelletier reported that the response to Amphora has been very positive.