Sexual Arousal DisorderPhase 2NCT00425256
Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD)
A Phase 2 study testing Bremelanotide in people with Sexual Arousal Disorder, run by Palatin Technologies, Inc at 20 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years, women only
- Conditions the study is for
- Sexual Arousal Disorder
- What is being tested?
- Bremelanotide
- How many people
- Not given
- Where
- 20 sitesUnited States
- Study dates
- Feb 2006to May 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- Women only
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
South Florida Medical Research
Aventura, Florida
Center for Sexual Medicine at Sheppard Pratt
Baltimore, Maryland
The Ohio State University
Columbus, Ohio
Downtown Women's Health Care
Denver, Colorado
Clinical Study Center
Fort Myers, Florida
Northeast Indiana Research
Fort Wayne, Indiana
Advanced Biomedical Research, Inc
Hackensack, New Jersey
Accelovance
Houston, Texas
Medical Affiliated Research Center
Huntsville, Alabama
University of California, Department of Family and Preventative Medicine
La Jolla, California
Medford Women's Clinic, LLP
Medford, Oregon
Coastal Connecticut Research
New London, Connecticut
Clinical Trials Research Services, LLC
Pittsburgh, Pennsylvania
The Center for Female Sexuality
Purchase, New York
Wake Research Associates, LLC
Raleigh, North Carolina
Women's Clinical Research Center
Seattle, Washington
Quality of Life Medical & Research Center, LLC
Tucson, Arizona
Center For Marital and Sexual Health of South Florida
West Palm Beach, Florida
Advanced Clinical Therapies, Inc.
West Reading, Pennsylvania
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina
About this study
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.
- Conditions
- Sexual Arousal Disorder
- Being tested
- Bremelanotide
- Medical subject headings
- Sexual Dysfunctions, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BremelanotideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2007 (estimated)
- Study startFeb 2006
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Arousal DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Palatin Technologies, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00425256
- Sponsor's protocol ID
- PT-141-2005-53
- Status last verified
- Feb 2011
- First submitted
- 18 Jan 2007
- Last updated
- 23 Feb 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD)
- ClinicalTrials.gov ID
- NCT00425256
- Acronym / sponsor ID
- PT-141-2005-53
- Conditions
- Sexual Arousal Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Palatin Technologies, IncIndustry (pharma, biotech, devices)
- Collaborators
- King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
- Study start
- Feb 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 22 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bremelanotide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2011.
Related trials for Sexual Arousal Disorder
Not yet recruiting
Transdermal Testosterone Gel for Female Sexual Interest and Arousal Disorder in Peri- and Post Menopause
Menopause, Sexual Dysfunction
Recruiting
Effect Study of SMART Treatment for Youth
Stress Disorders, Traumatic, Psychological Trauma
Not yet recruitingPhase 2
Evaluation of the Efficacy in Increasing Sexual Arousal, Safety and Tolerability of BZ371A in Women With Sexual Arousal Disorder
Female Sexual Arousal Disorder, Female Sexual Dysfunction (FSD)
Recruiting
Cognitive-Behavioural Couple Therapy for Sexual Interest/Arousal Disorder
Sexual Interest/Arousal Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bremelanotide in people with Sexual Arousal Disorder, run by Palatin Technologies, Inc at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2011.