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. Identifier: NCT00425256
Recruitment Status : Completed
First Posted : January 22, 2007
Last Update Posted : February 23, 2011
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Information provided by:
Palatin Technologies

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

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

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

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 identifier (NCT number): NCT00425256

  Hide Study Locations
United States, Alabama
Medical Affiliated Research Center
Huntsville, Alabama, United States
United States, Arizona
Quality of Life Medical & Research Center, LLC
Tucson, Arizona, United States
United States, California
University of California, Department of Family and Preventative Medicine
LaJolla, California, United States
United States, Colorado
Downtown Women's Health Care
Denver, Colorado, United States
United States, Connecticut
Coastal Connecticut Research
New London, Connecticut, United States
United States, Florida
South Florida Medical Research
Aventura, Florida, United States
Clinical Study Center
Ft. Myers, Florida, United States
Center For Marital and Sexual Health of South Florida
West Palm Beach, Florida, United States
United States, Indiana
Northeast Indiana Research
Fort Wayne, Indiana, United States
United States, Maryland
Center for Sexual Medicine at Sheppard Pratt
Baltimore, Maryland, United States
United States, New Jersey
Advanced Biomedical Research, Inc
Hackensack, New Jersey, United States
United States, New York
The Center for Female Sexuality
Purchase, New York, United States
United States, North Carolina
Wake Research Associates, LLC
Raleigh, North Carolina, United States
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, United States
United States, Ohio
The Ohio State University
Columbus, Ohio, United States
United States, Oregon
Medford Women's Clinic, LLP
Medford, Oregon, United States
United States, Pennsylvania
Clinical Trials Research Services, LLC
Pittsburgh, Pennsylvania, United States
Advanced Clinical Therapies, Inc.
West Reading, Pennsylvania, United States
United States, Texas
Houston, Texas, United States
United States, Washington
Women's Clinical Research Center
Seattle, Washington, United States
Sponsors and Collaborators
Palatin Technologies
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

Responsible Party: Robert Jordan, Palatin Technologies, Inc. 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
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs