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

This study has been completed.
Sponsor:
Collaborator:
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Information provided by:
Palatin Technologies
ClinicalTrials.gov Identifier:
NCT00425256
First received: January 18, 2007
Last updated: February 22, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Sexual Arousal Disorder
Drug: Bremelanotide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind

Further study details as provided by Palatin Technologies:

Study Start Date: February 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Female
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425256

  Show 20 Study Locations
Sponsors and Collaborators
Palatin Technologies
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Robert Jordan, Palatin Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00425256     History of Changes
Other Study ID Numbers: PT-141-2005-53
Study First Received: January 18, 2007
Last Updated: February 22, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Disease
Sexual Dysfunctions, Psychological
Mental Disorders
Pathologic Processes
Sexual and Gender Disorders

ClinicalTrials.gov processed this record on November 20, 2014