Intrarosa for Dyspareunia, What It Is and How It Works

Intrarosa is a vaginal suppository with the active ingredient prasterone, also known as dehydroepiandrosterone or DHEA. This substance occurs naturally in the human body. In fact, it is the most abundant steroid hormone found in the human body. DHEA is the chemical from which the body makes both male and female sex hormones, both estrogen and testosterone. However, it also has hormonal potency of its own, binding to receptor sites on nerves to act as an "allosteric modulator," which can either tone down or amplify the effects of other hormones. It is responsible for the maturing of the adrenal glands during early adolescence, triggering the production of skin oils, the growth of hair, and the acquisition of adult body odor. All of these effects can occur in the female reproductive organs during use of the supplement (by mouth) or as a vaginal insert.

Intrarosa is made by the Canadian drug manufacturer Endoceutics, based in Quebec.

During clinic trials, the Endoceutics researchers found that Pap smears were different in women who had been taking the medication for 12 weeks. Before taking the medication, the cells in the vagina and cervix were smaller, less capable of making lubricating fluids, generally associated with a condition called anestrus, a lack of sexual (or more specifically reproductive) desire. After taking the medication, the cells were larger, producing more lubricating fluids, and more characteristic of the kinds of cells seen in Pap smears of sexually active women.

The women in the clinical trial who were given Intrarosa, not the placeo:

• Had lower vaginal pH, which would mean that they were less susceptible to vaginitis, urinary tract infections, and other infections of the external sex organs.
• Were less likely to report pain associated with sexual intercourse, and
• Were less likely to report vulvar itching or vaginal dryness.

Their pathology reports also showed objectively measured more vaginal lubrication, thicker vaginal membrane, fewer visible abrasions, and better color. There was just one problem with the treatment. It tended to melt at body temperature (and would presumably be more likely to melt when it is not used in Canada). The melting suppository created a vaginal discharge in about 6 percent of the women who used it. It did not cause changes in estrogen or testosterone levels that could be measured by a blood test. Its effects were limited to the linings of the organs directly involved in sexual intercourse. There is no reason to believe that using Intrarosa would increase the risk of endrometrial cancer, ovarian cancer, breast cancer, or cardiovascular disease.

Some websites report that there were no quantitative data reported to the FDA prior to approval of the drug. This isn't true. The numbers simply weren't in the press release. They were included in the published research. Those numbers show that Intrarosa doesn't work for absolutely every woman who uses it. In the clinical trials, 84 percent of women using the drug had more lubrication at the end of the twelve weeks of the clinical study. Intrarosa may not be the complete answer to the problems of painful intercourse, but for most women, it will help.