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

  Hide Study Locations
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
Accelovance
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
  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 August 28, 2014