Topical Alprostadil for Female Sexual Arousal Disorder

Completed · Phase 2

Conditions studied: Sexual Dysfunction, Physiological

In brief

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).

Key facts

Study ID

NCT00324948

Run by

VIVUS LLC

People needed

300

Starts

2004-09-01

Expected to finish

2006-11-01

Last updated by the study team

2009-03-10

Who can join

Age: 21 and older, up to 60. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University School of Medicine-Dept of OB/GYN — Stanford, California, United States
• Radiant Research — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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