The female condom-long anticipated as a way for women to protect themselves against AIDS and other sexually transmitted diseases-is coming to Philadelphia to be put to the test.
Starting in the fall, about 1,100 women are expected to be subjects in two pioneering studies. Public health officials hope the tests will prove that the female condom can give women more control over pregnancy and disease.
If it proves successful, the female condom could be the answer for millions of women in poor parts of the United States and developing countries-women from cultures where their male sex partners refuse to use condoms and the women have little power to insist.
At a time when AIDS is spreading most rapidly among women, especially in underdeveloped countries, such a solution is sorely needed.
As of March, according to the Philadelphia Department of Public Health, women made up 12 percent of the 5,738 AIDS cases diagnosed in Philadelphia since the epidemic began in 1981. Two years ago, women made up 8 percent of the cases diagnosed in the city.
Tuesday, a health department committee voted to approve the tests, which will involve women who are patients at the department’s sexually transmitted disease clinic, Health Center 1.
One study would measure whether the female condom provides physical protection against gonorrhea, chlamydia and other diseases, including AIDS. The other study would find out if women will use it.
“For the first time, we could arm the female with an effective barrier which she could use to arm and protect herself,” said Allen Chandler, the medical director of the health department and chairman of the committee, called the Institutional Review Board. “With all the problems with what is out there-from males not wanting to use male condoms to their abuse of females who try to get males to use them-it was thought that this was a needed product.”
The female condom is a polyurethane sheath with a ring at both ends. It was approved last year by the federal Food and Drug Administration as a contraceptive and began appearing in stores, in Philadelphia, this summer.
Clinical trials have found it to be about as effective in preventing pregnancy as the diaphragm, the sponge and the cervical cap. But only one study has been completed linking the female condom to prevention of sexually transmitted diseases. That study found that women who used the condom were not reinfected with “trichomoniasis,” a sexually transmitted parasite, said Pamela French, study physician at Health Center 1.
Even if the female condom, called the Reality condom by its manufacturer, proves effective in the Philadelphia tests, many people still might find it undesirable. Reality is a funny-looking device, part of which hangs out of the vagina. It can’t be kept secret from a sex partner who might object to its use. If not adequately lubricated, it can make squeaking noises during intercourse.
Reality also may not be affordable to some of the women who need it most.
The condoms retail for $2.75 to $3 apiece, more than twice the price of a male condom.
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The health department, however, will be providing the condoms free. And French and others say that, once women and men get used to Reality, they tend to find it more comfortable and less constricting than a male condom.
The first Philadelphia study would involve 500 women, all of whom had been infected with a sexually transmitted disease other than HIV within three months before the start of the study. These would be women who clearly had been unsuccessful using other types of protection. French said most of the women who go to her clinic would qualify.
The study was funded, at the request of the health department, by the manufacturer, Female Health Co.
The clinic would give female condoms to 250 of the women and male condoms to the other 250. For a year the women would use the condoms each time they had intercourse, returning to the clinic periodically for examinations. Each woman would be required to sign a detailed consent form.
The second test, a “hierarchical study,” is geared to finding out what kind of protection women will use when given a choice.
“Currently all we offer are male condoms,” said Judith O’Donnell, the medical director of Health Center 1. “That’s it. We say, `Here’s a bag of condoms.’ This is going to give everyone a much better chance of not coming back with sexually transmitted diseases.”