Topical Alprostadil for Female Sexual Arousal Disorder

• Sponsor: VIVUS LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00324948
• Collaborator: (none)
• Enrollment: 300
• Locations: 2
• Duration (Months): 26
• Patients Per Site: 150
• Patients Per Site Per Month: 5.8

Study Details

Study Description

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-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).

Condition or Disease	Intervention/Treatment	Phase
Sexual Dysfunction, Physiological	Drug: Topical alprostadil (PGE-1)	Phase 2

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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Double-Blind, Randomized, 6-Month Evaluation of the Safety and Efficacy of Topical Alprostadil in Hysterectomized Women With Female Sexual Arousal Disorder (FSAD)
• Study Start Date: Sep 1, 2004
• Actual Primary Completion Date: Aug 1, 2006
• Actual Study Completion Date: Nov 1, 2006

Outcome Measures

Primary Outcome Measures

1. FSEP []

Secondary Outcome Measures

1. FSFI []

2. Global assessment []

3. Adverse events []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine-Dept of OB/GYN	Stanford	California	United States	94305
2	Radiant Research	Cincinnati	Ohio	United States	95249

Sponsors and Collaborators

• VIVUS LLC

Investigators

• Study Director: Sam Teichman, MD, Vivus Clinical Research Department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00324948
• Other Study ID Numbers: Vivus-FSD-10
• First Posted: May 11, 2006
• Last Update Posted: Mar 10, 2009
• Last Verified: Mar 1, 2009

• Keywords provided by , ,: Female sexual arousal disorder; Female sexual dysfunction
• Additional relevant MeSH terms: Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Alprostadil

Study Results

No Results Posted as of Mar 10, 2009