Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD)
1 other identifier
interventional
N/A
1 country
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2006
Shorter than P25 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 18, 2007
CompletedFirst Posted
Study publicly available on registry
January 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedFebruary 23, 2011
February 1, 2011
1.2 years
January 18, 2007
February 22, 2011
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Medical Affiliated Research Center
Huntsville, Alabama, United States
Quality of Life Medical & Research Center, LLC
Tucson, Arizona, United States
University of California, Department of Family and Preventative Medicine
La Jolla, California, United States
Downtown Women's Health Care
Denver, Colorado, United States
Coastal Connecticut Research
New London, Connecticut, United States
South Florida Medical Research
Aventura, Florida, United States
Clinical Study Center
Fort Myers, Florida, United States
Center For Marital and Sexual Health of South Florida
West Palm Beach, Florida, United States
Northeast Indiana Research
Fort Wayne, Indiana, United States
Center for Sexual Medicine at Sheppard Pratt
Baltimore, Maryland, United States
Advanced Biomedical Research, Inc
Hackensack, New Jersey, United States
The Center for Female Sexuality
Purchase, New York, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
Medford Women's Clinic, LLP
Medford, Oregon, United States
Clinical Trials Research Services, LLC
Pittsburgh, Pennsylvania, United States
Advanced Clinical Therapies, Inc.
West Reading, Pennsylvania, United States
Accelovance
Houston, Texas, United States
Women's Clinical Research Center
Seattle, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 18, 2007
First Posted
January 22, 2007
Study Start
February 1, 2006
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
February 23, 2011
Record last verified: 2011-02