Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD)
NCT00425256
Last updated date
ABOUT THIS STUDY
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.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Sexual Arousal Disorder
Sex
Female
Age
21-70 years
Inclusion Criteria
Show details
- 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
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Sexual Arousal DisorderEvaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD)
NCT00425256
- Huntsville, Alabama
- Tucson, Arizona
- LaJolla, California
- Denver, Colorado
- New London, Connecticut
- Aventura, Florida
- Ft. Myers, Florida
- West Palm Beach, Florida
- Fort Wayne, Indiana
- Baltimore, Maryland
- Hackensack, New Jersey
- Purchase, New York
- Raleigh, North Carolina
- Winston-Salem, North Carolina
- Columbus, Ohio
- Medford, Oregon
- Pittsburgh, Pennsylvania
- West Reading, Pennsylvania
- Houston, Texas
- Seattle, Washington
Female
21 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information | |||
---|---|---|---|
Brief Title ICMJE | Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD) | ||
Official Title ICMJE | Not Provided | ||
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. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 2 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double | ||
Condition ICMJE | Sexual Arousal Disorder | ||
Intervention ICMJE | Drug: Bremelanotide | ||
Study Arms ICMJE | Not Provided | ||
Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||
Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Enrollment ICMJE | Not Provided | ||
Original Enrollment ICMJE | Not Provided | ||
Actual Study Completion Date ICMJE | May 2007 | ||
Actual Primary Completion Date | May 2007 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
| ||
Sex/Gender ICMJE |
| ||
Ages ICMJE | 21 Years to 70 Years (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | Not Provided | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00425256 | ||
Other Study ID Numbers ICMJE | PT-141-2005-53 | ||
Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Robert Jordan, Palatin Technologies, Inc. | ||
Study Sponsor ICMJE | Palatin Technologies | ||
Collaborators ICMJE | King Pharmaceuticals is now a wholly owned subsidiary of Pfizer | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Palatin Technologies | ||
Verification Date | February 2011 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |