It looks odd and even its supporters concede it takes some getting used to, but the first condom designed to be worn by women is about to go on the world market.
In clinical trials, the new condom, also known as a vaginal pouch, appears to be far more effective than male condoms in protecting women from sexually transmitted diseases, while offering roughly equivalent protection against pregnancy.
"The idea of trying to get [some] men to wear a condom is impossible, and women are unfairly being put in the most vulnerable position," said Dr. Mervyn Silverman, president of the American Foundation for AIDS Research and a consultant to the company developing the device.
"I think the female condom has the potential of having a significant effect on empowering women to deal with the epidemic of AIDS," he said.
The female condom will be introduced in Switzerland next month and in France a month or two after that, said George Huber, managing director of London-based Chartex International PLC.
In the United States, the female condom could be available by fall, said Mary Ann Leeper, senior vice president of Wisconsin Pharmacal Co., which will market it in North America.
A Food and Drug Administration advisory panel is expected to recommend approval of the device at a hearing Jan. 31. That's just three months after Wisconsin Pharmacal submitted an updated application for marketing approval.
"This [panel] has never accelerated an application like this before," Ms. Leeper said. "I think Magic Johnson [the Los Angeles Lakers basketball star who announced he had the virus that causes AIDS] has raised everyone's awareness, even the FDA's, about how important it is to get products . . . to market as quickly as possible."
The increasing concern about sexually transmitted disease may prove to be a lifesaver for the female condom, which has attracted widespread skepticism since being invented in Denmark in the 1980s. Wisconsin Pharmacal first applied for U.S. regulatory approval in January 1989, but the FDA ordered it to do more extensive tests on the effectiveness and possible side effects of the device.
The female condom is essentially a large, lubricated, very thin polyurethane pouch with an inner and outer ring. The inner ring is inserted into the vagina, much like a diaphragm or contraceptive sponge, while the outer ring of polyurethane is spread over the front of the vaginal area. That protects the woman from contact with sperm or genital sores.
Ms. Leeper said trials showed more than 65 percent of female users and 80 percent of their male partners approved of the device. It is designed for one-time-only use.
"When I first saw it, I said, . . . 'Nobody will ever use it,' " said Dr. Freedolph Anderson, an associate professor of obstetrics and gynecology at Eastern Virginia Medical School in Norfolk. Dr. Anderson conducted research on the contraceptive effectiveness of the condom and its aesthetic acceptability.
"But it's amazing," he said. "The people who liked it [in clinical trials] really liked it and want to continue to use it. It's like anything else: Some people will like it, some people won't."
One couple who took part in a six-month clinical trial said they liked the pouch because it was easy to use and less likely than regular condoms to break. But another couple, who had used the contraceptive pill before taking part in the trials, said they found the pouch less spontaneous and somewhat comical.
Clinical trials of the female condom with 1,700 women showed that it had a leakage or defect rate of 0.6 percent, one-sixth of the 3.5 percent rate of male condoms, Wisconsin Pharmacal said.
The female condom will sell for $2 to $2.25 each. Male condoms typically sell for about 70 cents each.