Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-01 @ 7:39 AM
Study NCT ID:
NCT00425256
Status:
COMPLETED
Last Update Posted:
2011-02-23
First Post:
2007-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C476721', 'term': 'bremelanotide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-22', 'studyFirstSubmitDate': '2007-01-18', 'studyFirstSubmitQcDate': '2007-01-19', 'lastUpdatePostDateStruct': {'date': '2011-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Sexual Arousal Disorder']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post menopausal and in general good health\n* In a stable relationship with a male partner for at least 6 months\n* Willing to attempt sexual activity once a week with your partner'}, 'identificationModule': {'nctId': 'NCT00425256', 'briefTitle': 'Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Palatin Technologies, Inc'}, 'orgStudyIdInfo': {'id': 'PT-141-2005-53'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Bremelanotide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Medical Affiliated Research Center', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Quality of Life Medical & Research Center, LLC', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Department of Family and Preventative Medicine', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': "Downtown Women's Health Care", 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'New London', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Coastal Connecticut Research', 'geoPoint': {'lat': 41.35565, 'lon': -72.09952}}, {'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'South Florida Medical Research', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Study Center', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Center For Marital and Sexual Health of South Florida', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Northeast Indiana Research', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Center for Sexual Medicine at Sheppard Pratt', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Advanced Biomedical Research, Inc', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'city': 'Purchase', 'state': 'New York', 'country': 'United States', 'facility': 'The Center for Female Sexuality', 'geoPoint': {'lat': 41.04093, 'lon': -73.71457}}, {'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Research Associates, LLC', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Lyndhurst Gynecologic Associates', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': "Medford Women's Clinic, LLP", 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Clinical Trials Research Services, LLC', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'West Reading', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Advanced Clinical Therapies, Inc.', 'geoPoint': {'lat': 40.3337, 'lon': -75.94743}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Accelovance', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Women's Clinical Research Center", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Palatin Technologies, Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'King Pharmaceuticals is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Robert Jordan', 'oldOrganization': 'Palatin Technologies, Inc.'}}}}