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

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NCT00425256

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Study Location
Medical Affiliated Research Center
Huntsville, Alabama, , United States
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Contact
1-800-718-1021
[email protected]izer.com
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Sexual Arousal Disorder
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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
  1. Huntsville, Alabama
  2. Tucson, Arizona
  3. LaJolla, California
  4. Denver, Colorado
  5. New London, Connecticut
  6. Aventura, Florida
  7. Ft. Myers, Florida
  8. West Palm Beach, Florida
  9. Fort Wayne, Indiana
  10. Baltimore, Maryland
  11. Hackensack, New Jersey
  12. Purchase, New York
  13. Raleigh, North Carolina
  14. Winston-Salem, North Carolina
  15. Columbus, Ohio
  16. Medford, Oregon
  17. Pittsburgh, Pennsylvania
  18. West Reading, Pennsylvania
  19. Houston, Texas
  20. 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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
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