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

February 22, 2011 updated by: Palatin Technologies, Inc
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Palatin Technologies, Inc

Collaborators

King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

January 18, 2007

First Submitted That Met QC Criteria

January 19, 2007

First Posted (Estimate)

January 22, 2007

Study Record Updates

Last Update Posted (Estimate)

February 23, 2011

Last Update Submitted That Met QC Criteria

February 22, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PT-141-2005-53

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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