Source: Neuroimaging Clin N Am  |  Posted 6 years ago

By Amanda Strong

MONTREAL, QC -- October 20, 2005 -- Application of alprostadil cream appears to improve sexual arousal in women with female sexual arousal disorder (FSAD), according to the results of a phase 2, placebo-controlled clinical trial.

Joseph Mo, PhD, President and Chief Executive Office, NexMed, Robbinsville, New Jersey, United States, presented the findings here October 19[^]th[] during two presentations at the annual meeting of the American Society of Reproductive Medicine (ASRM).

Alprostadil is an off-patent prostaglandin E1 analogue. It is currently being used as a treatment for erectile dysfunction (ED), administered by either urethral suppository or injection to the penis.

Usefulness of the cream in women with FSAD was supported by findings from previous studies, which showed that the cream could induce and increase neurological communication to the sexual receptors in the brain, Dr. Mo said in an interview.

Researchers enrolled 400 women with symptoms of FSAD aged 21 to 65 years. The women were randomly assigned to receive treatment with 500, 700 or 900 mcg alprostadil cream or placebo cream.

The study was divided into two 2-month treatment phases. The first phase was preceded by a 4-week non-treatment baseline period. Each woman was given 5 doses per treatment phase to apply at home 10 to 15 minutes prior to sexual activity. The cream was applied to the clitoris and g-spot. Assessments were made at baseline and following the first and second treatment phases.

The primary efficacy endpoint -- arousal success rate -- increased from baseline across all groups; however there was also a large placebo effect. Only the 900 mcg group showed statistically significant improvements during both the first and second treatment periods, with increases of 38.7% (P = .001) and 51.4% (P = .0002), respectively, compared to 17.0% and 28.6%, respectively, for placebo.

Improvement in Female Sexual Function Index (FSFI) scores were observed at the end of the first treatment period across all groups; however, statistical significance versus placebo was only achieved in the second study period in the 900 mcg group (+22.9 vs. +14.7 for placebo; P < .0167).

A similar pattern was seen in Female Sexual Distress Scale (FSDS) scores, with statistical significant decreases versus placebo only being achieved in the 900 mcg group at the end of period 2 (-26.0 vs. -17.6% for placebo; P < .0167).

The most commonly reported adverse events were genital pain and burning at the site of application. Overall adverse events occurred in 15% of placebo patients and 23%, 19%, and 32% of patients receiving 500, 700, or 900 mcg of alprostadil cream, respectively.

The majority of adverse events were mild or moderate in intensity, reversible, and short in duration. Five patients discontinued due to adverse events (1.2%).

The investigators concluded that 900 mcg alprostadil cream significantly improves sexual arousal rates in women with FSAD and that the effect is further enhanced with continued use. The significant placebo effect observed might be attributable in part to the site and method of application.

The study was supported by NexMed Inc., which manufactures alprostadil topical cream for FSAD under the trade name Femprox(R) and for erectile dysfunction under the trade name Alprox-TD(R). Both drugs are currently under review by the U.S. Food and Drug Administration (FDA). Alprox-TD(R) is currently available in Hong Kong and China under the trade name Befar(R). NexMed Inc. also holds the patent on the drug delivery system used in both FemProx and Alprox-TD.

[Presentation titles: Enhanced Effects of Specially Formulated Topical Alprostadil Cream by a Continuous Dosing Remedy for the Treatment of Female Sexual Arousal Disorder (FSAD) in a Double-Blind, Multicenter, Randomized, and Placebo-Controlled Clinical Trial. O-322; A Randomized, Placebo-Controlled, Double-Blind, Parallel Design Study of the Efficacy and Safety of Specially Formulated Alprostadil Topical Cream in Patients With Female Sexual Arousal Disorder. O-328]