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Topical Alprostadil Appears Effective in Female Sexual Dysfunction: Presented at AUA

By Ed Susman
Special to DG News

ORLANDO, FL -- May 28, 2002 -- A droplet of fluid containing alprostadil appears to relieve symptoms of female sexual dysfunction while improving sexual desire, genital sensation and sexual satisfaction, doctors reported here Monday at the 97^th annual meeting of the American Urological Association.

The treatment could provide the first drug therapy for female sexual dysfunction, said Marc Gittelman, MD, lead investigator of the study, from South Florida Medical Research, in Aventura, Florida.

For their placebo-controlled, randomized multi-center study, Dr. Gittelman and colleagues recruited 78 women, mean age 55 years, to test topical alprostadil, dispensed by an eyedropper into the female genitalia. Sixty-seven percent of the women were postmenopausal and the remainder had either received a hysterectomy or bilateral oophorectomy.

Dr. Gittelman said that the women filled out questionnaires designed to determine if they suffer from sexual dysfunction. "These questionnaires have been scientifically validated," he said.

Half the women received the drug in the liquid vehicle; the other women received placebo. The women in the alprostadil group were given either a 100 µg dose or a 400 µg dose. The "no touch" study was performed in doctors' offices. The women watched erotic films and then applied the fluid to the clitoris and allowed it to spread to the surrounding tissues.

The women reported feelings of genital warmth, sexual arousal and sexual satisfaction that were more significantly more intense if they received the higher dose of alprostadil than if they received placebo, said co-author Col. Raymond Costabile, MD, chief of urology service at Madigan Army Medical Center, Tacoma, Washington.

There was no difference in responses between postmenopausal women and women who had undergone hysterectomy/oophorectomy.

Dr. Gittelman said some of the women reported experiencing orgasm, despite the clinical nature of the study. He said further studies in which the drug will be used at home in situations involving sexual intercourse will determine if the drug works as expected.

"This area of female sexual dysfunction is just exploding," said Dr. Wayne Hellstrom, professor of urology at Tulane University, in New Orleans, Louisiana. "It is something that we don't have any treatment for, and this drug does look promising."

Dr. Costabile said adverse side effects were few and generally well-tolerated. Some women reported feeling uncomfortable burning sensations, but those sensations lasted less than a minute, he said.

The study was sponsored by Vivus, of Mountain View, California, developer of topical alprostadil.

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