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

NCT ID: NCT00425256

Last Updated: 2011-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2007-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sexual Arousal Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bremelanotide

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role collaborator

Palatin Technologies, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Palatin Technologies, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical Affiliated Research Center

Huntsville, Alabama, United States

Site Status

Quality of Life Medical & Research Center, LLC

Tucson, Arizona, United States

Site Status

University of California, Department of Family and Preventative Medicine

La Jolla, California, United States

Site Status

Downtown Women's Health Care

Denver, Colorado, United States

Site Status

Coastal Connecticut Research

New London, Connecticut, United States

Site Status

South Florida Medical Research

Aventura, Florida, United States

Site Status

Clinical Study Center

Fort Myers, Florida, United States

Site Status

Center For Marital and Sexual Health of South Florida

West Palm Beach, Florida, United States

Site Status

Northeast Indiana Research

Fort Wayne, Indiana, United States

Site Status

Center for Sexual Medicine at Sheppard Pratt

Baltimore, Maryland, United States

Site Status

Advanced Biomedical Research, Inc

Hackensack, New Jersey, United States

Site Status

The Center for Female Sexuality

Purchase, New York, United States

Site Status

Wake Research Associates, LLC

Raleigh, North Carolina, United States

Site Status

Lyndhurst Gynecologic Associates

Winston-Salem, North Carolina, United States

Site Status

The Ohio State University

Columbus, Ohio, United States

Site Status

Medford Women's Clinic, LLP

Medford, Oregon, United States

Site Status

Clinical Trials Research Services, LLC

Pittsburgh, Pennsylvania, United States

Site Status

Advanced Clinical Therapies, Inc.

West Reading, Pennsylvania, United States

Site Status

Accelovance

Houston, Texas, United States

Site Status

Women's Clinical Research Center

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PT-141-2005-53

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Fesoterodine Flexible Dose Study
NCT00536484 COMPLETED PHASE3
Treatment of Patients With Nocturia
NCT00937859 COMPLETED PHASE3