Status:
COMPLETED
Topical Alprostadil for Female Sexual Arousal Disorder
Lead Sponsor:
VIVUS LLC
Conditions:
Sexual Dysfunction, Physiological
Eligibility:
FEMALE
21-60 years
Phase:
PHASE2
Brief 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-t...
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00324948
Start Date
September 1 2004
End Date
November 1 2006
Last Update
March 10 2009
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford University School of Medicine-Dept of OB/GYN
Stanford, California, United States, 94305
2
Radiant Research
Cincinnati, Ohio, United States, 95249