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. “It is viscous and doesn’t leak. There are no known side effects. The effectiveness is anticipated to be similar to the real in practice results of Conceptrol, 85 to 90%, depending on how compliant the users are with the recommended protocol.”
After completion of the current trial, Evofem is planning to co-formulate and test Amphora with the anti-STI drug, Tenofovir gel.
Tenofovir gel is an anti-retroviral that is in its third clinical trial in Africa through the FACTS 0001 study as an anti-HIV and anti-HSV-2 drug. A previous 2010 study showed that Tenofovir gel reduced HIV by 54 percent in women who used it at least 80 percent of the time. In the same study, the gel lowered women’s risk of getting genital herpes by 51 percent.
If Amphora can be effectively combined with an STI-preventive medication, its use in both the general population and in underdeveloped countries would be tremendous.
Pelletier estimates that Amphora may be available in mid-2015 for use as a contraceptive alone. A combined product could come out later if found to be effective in future clinical trials.
It will be exciting to see a new contraceptive gel that does not contain spermicide or hormones appear on the market at an affordable cost.
Women will be able to use a method without a risk of side effects that is discrete, inexpensive and effective.
Sources:
Evofem to Start Largest Clinical Trial. March 20, 2011.
http://www.amphora.com/news/evofem-to-start-largest-contraceptive-clinic...
Phone interview with Saundra Pelletier July 16th, 2013.
Facts Consortium. WORKING TOGETHER TO PREVENT HIV. Retrieved July 20, 2013.
http://www.facts-consortium.co.za/?page_id=83
Michele is an R.N. freelance writer with a special interest in woman’s healthcare and quality of care issues. Other articles by Michele are at www.helium.com/users/487540/show_articles
Edited by Jody Smith