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NCT00425256 Clinical Trial

Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD)

Sexual Arousal Disorder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00425256
Other study ID # PT-141-2005-53
Secondary ID
Status Completed
Phase Phase 2
First received January 18, 2007
Last updated February 22, 2011
Start date February 2006
Est. completion date May 2007

Study information
Verified date February 2011
Source Palatin Technologies
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This 8 week at home study is designed to explore efficacy endpoints and evaluate the safety of intranasal Bremelanotide in women with Female Sexual Arousal Disorder. Efficacy will be assessed vs. a parallel placebo group.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date May 2007
Est. primary completion date May 2007
Accepts healthy volunteers
Gender Female
Age group 21 Years to 70 Years
Eligibility Inclusion Criteria:

- Post menopausal and in general good health

- In a stable relationship with a male partner for at least 6 months

- Willing to attempt sexual activity once a week with your partner

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

Intervention

Drug:
• Bremelanotide

Locations
Country Name City State
United States South Florida Medical Research Aventura Florida
United States Center for Sexual Medicine at Sheppard Pratt Baltimore Maryland
United States The Ohio State University Columbus Ohio
United States Downtown Women's Health Care Denver Colorado
United States Northeast Indiana Research Fort Wayne Indiana
United States Clinical Study Center Ft. Myers Florida
United States Advanced Biomedical Research, Inc Hackensack New Jersey
United States Accelovance Houston Texas
United States Medical Affiliated Research Center Huntsville Alabama
United States University of California, Department of Family and Preventative Medicine LaJolla California
United States Medford Women's Clinic, LLP Medford Oregon
United States Coastal Connecticut Research New London Connecticut
United States Clinical Trials Research Services, LLC Pittsburgh Pennsylvania
United States The Center for Female Sexuality Purchase New York
United States Wake Research Associates, LLC Raleigh North Carolina
United States Women's Clinical Research Center Seattle Washington
United States Quality of Life Medical & Research Center, LLC Tucson Arizona
United States Center For Marital and Sexual Health of South Florida West Palm Beach Florida
United States Advanced Clinical Therapies, Inc. West Reading Pennsylvania
United States Lyndhurst Gynecologic Associates Winston-Salem North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Palatin Technologies King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

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