NCT00324948

Topical Alprostadil for Female Sexual Arousal Disorder

A Double-Blind, Randomized, 6-Month Evaluation of the Safety and Efficacy of Topical Alprostadil in Hysterectomized Women With Female Sexual Arousal Disorder (FSAD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (planned)
• Sponsor: VIVUS LLC · Industry
• Sex: Female
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Approximately 300 patients with female sexual arousal disorder who meet eligibility criteria will be enrolled and randomized to receive either active drug or matching placebo. After a two-month, non-treatment period, patients will receive study drug for 6 months and will record information about sexual encounters in a daily diary. Study drug will be applied directly to the genital area 30-60 minutes before initiation of sexual activity. The endpoint of the study is based on the use of a standard measure of sexual function (FSEP).

Detailed description

This is a multicenter, double-blind, randomized, placebo-controlled, parallel-design study involving about 300 women who are 21-60 years of age inclusive, who have undergone a hysterectomy (with or without oophorectomy), and who have a primary diagnosis of FSAD. The diagnosis of FSAD will be made based on a medical and sexual history and confirmed using a structured interview by trained personnel. Study subjects will undergo a 2-month non-treatment run-in period followed by a 6-month period of blinded study therapy. Study drug is applied topically to the genitalia 30-60 minutes prior to initiation of sexual activity. Study subjects will complete several questionnaires at various times during the study and will complete a daily diary. The study endpoint is based on the FSEP and other standard questionnaires, as well as safety and tolerability of study drug.

Conditions

• Sexual Dysfunction, Physiological

Interventions

Type	Name	Description
DRUG	Topical alprostadil (PGE-1)

Timeline

• Start date: 2004-09-01
• Primary completion: 2006-08-01
• Completion: 2006-11-01
• First posted: 2006-05-11
• Last updated: 2009-03-10

Locations

2 sites across 1 country: United States