Topical Alprostadil for Female Sexual Arousal Disorder

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VIVUS, Inc.
• Treatments: Alprostadil

Criteria

Inclusion Criteria:

• Women aged 21-60 who have undergone a hysterectomy

• Have a primary diagnosis of female sexual arousal disorder

• Be willing to comply with all study requirements and visit schedules

Exclusion Criteria:

• Known allergy to alprostadil or product excipients

• Have a genital inflammatory or infectious condition or STD

• Have a significant medical condition that would interfere with the study

• Have received an investigational drug within the prior 30 days