Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD)
Sponsor
Palatin Technologies, Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT00425256
Collaborator
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer (Industry)
20
14.9
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Study Start Date
:
Feb 1, 2006
Actual Primary Completion Date
:
May 1, 2007
Actual Study Completion Date
:
May 1, 2007
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
21 Years
to 70 Years
Sexes Eligible for Study:
Female
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical Affiliated Research Center | Huntsville | Alabama | United States | |
| 2 | Quality of Life Medical & Research Center, LLC | Tucson | Arizona | United States | |
| 3 | University of California, Department of Family and Preventative Medicine | LaJolla | California | United States | |
| 4 | Downtown Women's Health Care | Denver | Colorado | United States | |
| 5 | Coastal Connecticut Research | New London | Connecticut | United States | |
| 6 | South Florida Medical Research | Aventura | Florida | United States | |
| 7 | Clinical Study Center | Ft. Myers | Florida | United States | |
| 8 | Center For Marital and Sexual Health of South Florida | West Palm Beach | Florida | United States | |
| 9 | Northeast Indiana Research | Fort Wayne | Indiana | United States | |
| 10 | Center for Sexual Medicine at Sheppard Pratt | Baltimore | Maryland | United States | |
| 11 | Advanced Biomedical Research, Inc | Hackensack | New Jersey | United States | |
| 12 | The Center for Female Sexuality | Purchase | New York | United States | |
| 13 | Wake Research Associates, LLC | Raleigh | North Carolina | United States | |
| 14 | Lyndhurst Gynecologic Associates | Winston-Salem | North Carolina | United States | |
| 15 | The Ohio State University | Columbus | Ohio | United States | |
| 16 | Medford Women's Clinic, LLP | Medford | Oregon | United States | |
| 17 | Clinical Trials Research Services, LLC | Pittsburgh | Pennsylvania | United States | |
| 18 | Advanced Clinical Therapies, Inc. | West Reading | Pennsylvania | United States | |
| 19 | Accelovance | Houston | Texas | United States | |
| 20 | Women's Clinical Research Center | Seattle | Washington | United States |
Sponsors and Collaborators
- Palatin Technologies, Inc
- King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00425256
Other Study ID Numbers:
- PT-141-2005-53
First Posted:
Jan 22, 2007
Last Update Posted:
Feb 23, 2011
Last Verified:
Feb 1, 2011
Additional relevant MeSH terms: