Second-generation female condom OK'd by FDA — What's next for the U.S.?
Second-generation female condom OK'd by FDA —What's next for the U.S.?
Campaign to kick off in 9-city push; search on for retail partner
Female-controlled prevention options are set to expand with the Food and Drug Administration (FDA) March 2009 approval of the second generation of the female condom manufactured by the Female Health Co. With the introduction of a new proprietary nitrile material and a less labor-intensive manufacturing process, the company will be able to offer the condom, known as the FC2, at a public health sector cost some 30% less than the original FC1 polyurethane condom.
Robert Hatcher, MD, MPH, professor of obstetrics and gynecology at Emory University in Atlanta, points to these key points about the FC2 condom:
- It is a source of female-controlled protection. "In Africa, 70% percent of women who become infected with the HIV virus are infected by their husbands, who in many instances refuse to use male condoms," notes Hatcher.
- The FC2 is less noisy than the polyurethane FC1 female condom,1 which may lead more women to use it.
- While the importance of an effective vaccine against AIDS and an effective vaginal microbicide cannot be denied, both are several years from being available, says Hatcher.
"Given the deplorable resistance of so many men to male condoms, the new female condom may be the best thing we have to offer women for the prevention of AIDS and other infections for the next 10 years," says Hatcher.
Look for Female Health Co. to make an announcement in early summer 2009 regarding public sector product availability and ordering information, says Mary Ann Leeper, PhD, the company's senior strategic adviser. Family planning agencies and health departments will be able to place orders directly with the company, rather than through a distributor, she reports. This move will enhance cost savings for agencies, Leeper explains.
The company will launch a nine-city campaign in early September to promote the public sector availability of the new condom, says Leeper. The campaign will target health departments, nonprofit community-based organizations, and nongovernmental organizations in Washington, DC; Chicago; Philadelphia; Atlanta; Houston; Miami; Baltimore; Los Angeles; and San Francisco, she states.
The campaign will include training based on New York City's successful female condom program. The city Department of Health and Mental Hygiene's female condom distribution program increased its allocation from 2006 to 2007 by 200,000 female condoms due to popularity of the program.2 In 2008, the department placed a contract to purchase 2 million female condoms to be distributed free of charge through health clinics and organizations across the city as part of its efforts to increase HIV prevention. Local public health officials estimate heterosexual transmission accounts for 92% of new HIV cases among women in the city.2
With the FDA approval now in hand, the U.S. Agency for International Development now can procure the second-generation female condom for U.S.-supported HIV/AIDS prevention and family planning programs around the world. To handle increased demand, the Female Health Co. plans to install six more production lines for the FC2 and increase its production capacity from 30 million units to about 75 million to 80 million units.
Health advocates also have launched a global campaign, Prevention Now!, to demand increased access to the female condom in communities heavily affected by HIV/AIDS. While public health programs around the world distribute 11 billion male condoms every year, 26 million female condoms were distributed in 2007, health advocates estimate.3
While female condoms may be a powerful tool in preventing transmission of sexually transmitted diseases (STDs), women need education in order to use them effectively. Results from a recent study indicate that skills training can increase female condom use and the overall level of protected sexual acts.4
The public sector will serve as the initial U.S. access point for the FC2 condom as the Female Health Co. searches for a retail partner. According to Leeper, the company is in talks with male condom companies, as well as pharmaceutical companies involved in over-the-counter female health products, to find the best fit for increased access for the FC2 condom. The company is searching for a business that is committed to women and will push to make the FC2 available to them, she says.
"Our whole focus is empowerment of women, and we want someone who is committed to do that," states Leeper.
Once a retail partner is found, marketing plans will be developed and distribution lines put in place, she says. She estimates it might be spring 2010 before the FC2 is available on U.S. retail pharmacy shelves.
The Program for Appropriate Technology in Health (PATH) is continuing its research of a female condom. The agency began research in 1996 to develop a woman's condom tailored to the needs of the women in the developing world, with support from the U.S. Agency for International Development, the Bill & Melinda Gates Foundation, and other donors. More than 50 prototypes were examined, with field testing performed in Mexico, South Africa, and Thailand. PATH entered a collaborative agreement in July 2008 with Chinese manufacturer Shanghai Dahua Medical Apparatus Co. to manufacture the condom.
The Woman's Condom (WC) is a 9-inch thin, pliable plastic pouch that conforms to the shape of the vagina. It has a flexible soft outer ring designed to protect the external genitalia, with four oblong foam pieces on the outside of the pouch that are engineered to cling lightly to vaginal walls, which ensures device stability. The distal end of the pouch and foam pieces are packaged into a capsule that serves as an insertion aid; it dissolves quickly when inserted into the vagina.5
In a randomized crossover study designed to evaluate the functional performance, safety, and acceptability of the FC1 and the WC, 75 couples were assigned to one of two condom use sequences (WC/FC1 or FC1/WC) at centers at the University of Pennsylvania Medical Center, University of Pittsburgh/Magee Womens Research Institute, and Advances in Health. Four condoms of the first type were used by couples during sex over a two- to four-week period. After a follow-up visit, these procedures were repeated with the second assigned condom type. In a substudy of 25 participants, a colposcopy was performed prior and subsequent to the first condom use of each of the two condom types.
Researchers evaluated condom performance by calculating measures of function from questionnaires completed by the couple after each condom use. Safety was evaluated by reported urogenital symptoms with a given condom during or immediately following condom use and colposcopic signs of genital irritation in the substudy.
Total condom failure (slippage, breakage, etc., divided by the number of female condoms opened) was 31% for the WC and 42% for the FC1; total clinical failure (slippage, breakage, etc., divided by the number of female condoms used) was 17% for the WC and 24% for the FC1. The proportion of condom failures was 10.9 percentage points less, and the proportion of clinical failure 6.7 percentage points less, when couples used the WC compared to the FC1 (90% confidence interval: -18.5 to -3.3 and -12.6 to -0.8, respectively).
Findings indicate that fewer women reported symptoms or signs of urogenital irritation when using the WC. Among participants with a preference, the WC was preferred over the FC1 by twice as many males and by 2.6 times as many females.5 The WC is ready for a combined Phase 2/3 clinical trial, say PATH officials.
References
- Smit J, Beksinska M, Mabude Z. Short-term acceptability of the Reality® polyurethane female condom and a synthetic latex prototype: A randomized crossover trial among South African women. Contraception 2006; 73:394-398.
- Shapiro D. Why New York State Needs the FC2 Now. Presented at the Food and Drug Administration Obstetrics and Gynecology Devices Panel meeting. Gaithersburg, MD; December 2008.
- Center for Health and Gender Equity. Saving Lives Now: Female Condoms and the Role of U.S. Foreign Aid. Takoma Park, MD; 2008.
- Choi K-H, Hoff C, Gregorich SE, et al. The efficacy of female condom skills training in HIV risk reduction among women: A randomized, controlled trial. Am J Public Health 2008; 98:1,841-1,848.
- Schwartz JL, Barnhart K, Creinin MD, et al. Comparative crossover study of the PATH Woman's Condom and the FC Female Condom. Contraception 2008; 78:465-473.
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