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Condom for women improves both choice and protection

IT MAY SEEM like a relatively cumbersome and expensive product. In fact, the whole idea may be difficult to get used to.

But by the end of the year drugstores may stock the latest in armor against unwanted pregnancy and sexually transmitted diseases, including AIDS: A sheath-style prophylactic women can wear.

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A Wisconsin firm is asking the federal Food and Drug Administration to let it begin selling the product in this country, perhaps as early as this fall. An FDA advisory panel will meet in Rockville Friday to consider the request.

Some reproductive specialists think the product could be more than just another protective device. The female condom could, they say, alter the balance of power in a dispute that has wrecked more than one amorous evening -- and increasingly threatens the health of women.

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"Right now, if a male refuses to use condoms, you have essentially two choices," said Dr. Doris Tirado, medical director of Planned Parenthood of Maryland. "You either have intercourse without using the condom. Or you refuse to have intercourse."

A condom that a woman can put on, Dr. Tirado said, "takes the decision out of the male's hands and empowers the woman."

This is more than just a matter of sexual etiquette. A woman is 20 times times more likely to be infected by the deadly AIDS virus through heterosexual intercourse than a man.

Here's what it looks like: The pouch-shaped device is 7 inches long, with a lubricated polyurethane membrane almost twice as thick as a latex male condom. It contains two flexible rings, one of which fits inside the vagina like a diaphragm, anchoring the sheath, while the other sits outside the body.

While a simple diaphragm is designed to stop sperm from getting past the cervix, it does not protect against infection of the vagina. A male condom leaves part of the genitals exposed, leaving a slight risk of the transmission of disease.

The female condom, on the other hand, lines the entire vagina and labia, shielding it from all skin-to-skin contact.

One size fits all. Like its male counterpart, the female condom is used once and discarded.

The new condom is expected to appear in stores in Switzerland early next month and in France and Britain later in the year.

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Studies by the company applying to sell the product in the United States, Wisconsin Pharmacal of Jackson, Wisc., show that during sex when a male condom is used, the probability the woman would be exposed to seminal fluid was 11.6 percent. When the couple used a female condom, that figure drops to 3 percent.

In theory, the potential market for the product is very large. There are an estimated 43 million women between the ages of 18 and 40 using contraception in this country.

But some health care professionals question whether the product will ever be widely used. Even the manufacturer points out it isn't for everyone.

Mary Ann Leeper, a senior vice president with Wisconsin Pharmacal, said her firm expects to sell the condom to single women who are actively dating and, understandably, are concerned about protecting themselves against AIDS.

"Couples who are not concerned about sexually transmitted diseases, because they have been married a long time and maybe have kids -- they're not going to switch to this device," she said.

Wisconsin Pharmacal hopes to market the device as the "Reality Intravaginal Pouch."

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Dr. Vanessa Collins, director of family planning for the Center for Addiction and Pregnancy of Francis Scott Key Medical Center, welcomed the product's introduction, saying, "It's a more complete barrier than the male condom when it comes to the protection of the woman."

But she added: "I do not think this is going to catch on quickly. I do think it should be in our contraceptive arsenal, because it can be very effective in preventing sexually transmitted diseases. But I really don't see that it's going to go into widespread use."

One major problem she foresees is that inserting the device "involves a lot of genital contact that a lot of women are uncomfortable with."

The inner ring of the condom, she pointed out, must be placed high up in the vagina, like a diaphragm or cervical cap.

"You have to have someone who's comfortable using that method," she said. "For the general population, that does not appear to be the case. Diaphragm use is low in this country. Cervical cap use is low in this country."

Dr. Collins and Dr. Tirado also said some men who complain about a loss of sensitivity from male condoms might have similar objections to the thicker female version.

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Studies by the manufacturer found some women consider the device cumbersome to use, or dislike the ring hanging outside the vagina.

But Dr. Leeper said those studies suggest many couples will ignore these objections. "The data show that the majority of women in our studies liked using Reality, about 75 percent of them," she said.

"But most of these, obviously, there's somewhat of a bias in the studies, because they're clinical studies," she cautioned. "It's not like going out on the market and putting your product up on a shelf."

In one test of Reality involving 400 women over a six-month period, Dr. Leeper said, only 17 percent stopped using the device because either the woman or her partner decided they didn't like it. "That's consistent with all the studies carried on in the United States, or outside the U.S., in terms of acceptability," she said.

Cost is another issue.

While most male condoms cost between 60 cents and 70 cents apiece, Wisconsin Pharmacal said each Reality condom will cost $2 to $2.25.

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"That's expensive," said Dr. Collins. Dr. Tirado said Planned Parenthood might not be able to afford to offer it to patients free of charge.

But Dr. Leeper said Reality was "in the same ballpark" with more expensive contraceptive methods, such as the pill. The pill, she said, costs about $220 a year, while Reality users would probably wind up spending $180 to $190 a year.

Considering all the potential resistance, Dr. Collins estimated only about 1 percent of her patients might wind up using the female condom.

But Dr. Leeper pointed out that even 1 percent of the 43 million women using contraception would represent 430,000 customers -- a large market, at least to start out.

Sharon Snider, a spokesman for the FDA, said when the agency's Obstetrics and Gynecology Panel considers the manufacturer's data Friday, it could recommend the FDA approve sale of the device, she said, or ask for further clinical studies or additional data. If the panel recommends approval, she said, a final decision by FDA Administrator Dr. David Kessler could take anywhere from a month to a year.


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