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
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:
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Alpha-MSH
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014