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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00425256
Recruitment Status : Completed
First Posted : January 22, 2007
Last Update Posted : February 23, 2011
Sponsor:
Collaborator:
Information provided by:

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
Sexual Arousal Disorder Drug: Bremelanotide Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Study Start Date : February 2006
Primary Completion Date : May 2007
Study Completion Date : May 2007
Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00425256


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

Responsible Party: Robert Jordan, Palatin Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00425256     History of Changes
Other Study ID Numbers: PT-141-2005-53
First Posted: January 22, 2007    Key Record Dates
Last Update Posted: February 23, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Mental Disorders
alpha-MSH
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs