Alprostadil Cream May Be Effective Against Female Sexual Arousal Disorder

October 20, 2005

Oct. 20, 2005 (Montreal) — A transdermal cream formulation of alprostadil may be an effective treatment for female sexual arousal disorder (FSAD), according to phase 2 research. Alprostadil is a naturally occurring form of prostaglandin E 1 (PGE 1), which is currently used to treat male erectile dysfunction.

"This is not a typical hormone replacement patch for women who have had their ovaries removed, and they don't have a normal sexual drive or desire," said Joseph Mo, PhD, president and CEO of NexMed, manufacturer of the alprostadil cream used in this trial. "In our case, we screened for women with normal sexual drive, but sometime during or after intercourse, they do not have pleasant sensations [associated with sexual activity]. We call that sexual arousal disorder." There are currently no approved medications for the treatment of FSAD.

For the double-blind trial, 400 women with FSAD aged 21 to 65 years were randomized to receive a 10-dose at-home treatment of 500, 700, or 900 µg ofalprostadil cream or a placebo cream. They were instructed to apply the cream to their clitoris and G spot.

The primary end point was arousal success rate, as determined by the number of "yes" responses on question 3 of the Female Sexual Encounter Profile (FSEP), "Were you satisfied with your arousal (excitement) during this sexual activity?" per sexual encounter. Secondary end points included scores on the Female Sexual Arousal Function Index (FSFI), Global Assessment Questionnaire (GAQ), Female Sexual Distress Scale (FSDS), and other FSEP responses. Dr. Mo presented the results here yesterday at the annual meeting of the American Society of Reproductive Medicine.

Overall, 372 patients completed the study. After they were given the first five doses of the cream, improvement in mean arousal during sexual encounters, as determined by patients' response to question 3 on the FSEP, demonstrated a significant improvement compared with baseline for all three doses of alprostadil.

Patients using 500 µg of alprostadil cream experienced a 32% increase ( P = .011), a 27.5% increase ( P = .086) was seen for patients using 700 µg, and 38.7% ( P = .0001) among those using 900 µg. In contrast, patients using the placebo cream had a 17% increase in this parameter.

After patients received the second five doses of the cream, these data improved even more, to 41.9% with 500 µg ( P = .053), 40.3% with 700 µg ( P = .074), and 51.4% with 900 µg ( P = .0002). Placebo patients improved by 28.6% after the second five doses.

Improvement in FSFI score, compared with baseline, after patients received the first five doses increased by 14.5% with 500 µg of alprostadil cream, by 15.7% with 700 µg, and by 18.2% with 900 µg. These further improved to 20.7%, 21.7%, and 22.9%, respectively, after patients received the second five doses of the cream. Among patients using a placebo cream, FSFI improved by 10.0% after the first five doses and 14.7% after the second five doses.

Similarly, FSDS score decreased by –14.7 with 500 µg of alprostadil, –13.8 with 700 µg, and –18.4 with 900 µg after the first five doses, and by –20.3, –22.0, and –26.0, respectively, after the second five doses. Patients receiving placebo cream had FSDS score decreases of –10.3 after the first five doses and –17.6 after the second five doses.

For all efficacy parameters, only the 900-µg dose of alprostadil cream provided outcomes that were statistically significantly higher than placebo, suggesting that this is the appropriate therapeutic dose of the drug.

Adverse events were relatively common with alprostadil cream, with 23%, 19%, and 32% of patients using the 500-, 700-, and 900-µg doses reporting adverse events, respectively, in comparison with 15% among those who received a placebo cream. These adverse events, however, were generally mild and transient and mainly limited to local irritation that disappeared as soon as the cream was washed away. Only 1.2% of patients in the trial discontinued because of adverse events.

Dr. Mo is enthusiastic about these findings and believes alprostadil cream could provide relief from FSAD for many women who have had not effective therapeutic options to date. "This is [also] something natural," he said. "We all have it. Men and women have a lot of prostaglandin E 1."

According to Dr. Mo, alprostadil cream would be applied about 15 minutes before engaging in intercourse. NexMed is continuing to conduct clinical trials with alprostadil and hopes to make it widely available in the U.S. in the near future under the brand name Femprox.

ASRM 2005 Annual Meeting: Abstract O-322. Presented Oct. 19, 2005.

Reviewed by Gary D. Vogin, MD


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