Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-13 @ 7:20 PM
Study NCT ID:
NCT00613002
Status:
COMPLETED
Last Update Posted:
2013-01-10
First Post:
2008-01-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women
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': 'D043343', 'term': 'Testosterone Propionate'}], 'ancestors': [{'id': 'D013739', 'term': 'Testosterone'}, {'id': 'D000737', 'term': 'Androstenols'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045165', 'term': 'Testosterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 597}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'dispFirstSubmitDate': '2013-01-04', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-04', 'studyFirstSubmitDate': '2008-01-30', 'dispFirstSubmitQcDate': '2013-01-04', 'studyFirstSubmitQcDate': '2008-01-30', 'dispFirstPostDateStruct': {'date': '2013-01-10', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Co-primary endpoints are the change in the 4-week total number of satisfying sexual events from the Baseline period to Weeks 21-24, and the change from Baseline to Weeks 21-24 in the mean ISED desire score.', 'timeFrame': 'Baseline and 21-24 weeks.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline over time for multiple efficacy measurements', 'timeFrame': 'change over timepoints from baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hypoactive sexual desire disorder', 'testosterone', 'menopause'], 'conditions': ['Hypoactive Sexual Desire Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bloomstudy.com', 'label': 'http://www.bloomstudy.com'}]}, 'descriptionModule': {'briefSummary': 'This study is a randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of LibiGel® 300mcg in the treatment of HSDD in surgically menopausal women'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be between the ages of 30 to 65 years\n* Must have undergone hysterectomy and bilateral salpingo-oophorectomy\n\nExclusion Criteria:\n\n* A history of allergic reactions to androgens (oral or patch), topical alcohol, or any component of the formulation\n* Any systemic skin diseases or local skin abnormalities in the area of application\n* Diagnosed with another primary female sexual dysfunction (e.g., Sexual Aversion Disorder, Female Sexual Arousal Disorder).\n* A medical condition that could affect or interfere with sexual function\n* Using a systemic topical gel or cream estrogen therapy.'}, 'identificationModule': {'nctId': 'NCT00613002', 'acronym': 'BLOOM', 'briefTitle': 'Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioSante Pharmaceuticals'}, 'officialTitle': 'A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of the Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women', 'orgStudyIdInfo': {'id': 'TESTW006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'testosterone gel', 'description': '1% testosterone transdermal gel', 'interventionNames': ['Drug: testosterone gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo gel', 'description': 'placebo transdermal gel', 'interventionNames': ['Drug: placebo gel']}], 'interventions': [{'name': 'testosterone gel', 'type': 'DRUG', 'otherNames': ['LibiGel'], 'description': 'once daily transdermal testosterone gel, 300 mcg', 'armGroupLabels': ['testosterone gel']}, {'name': 'placebo gel', 'type': 'DRUG', 'description': 'once daily transdermal placebo gel', 'armGroupLabels': ['placebo gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'BioSante Site #215', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35216', 'city': 'Hoover', 'state': 'Alabama', 'country': 'United States', 'facility': 'BioSante Site #095', 'geoPoint': {'lat': 33.40539, 'lon': -86.81138}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'BioSante Site #014', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85308', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'BioSante Site #027', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85715', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'BioSante Site #040', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'BioSante Site #052', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '90620', 'city': 'Buena Park', 'state': 'California', 'country': 'United States', 'facility': 'BioSante Site #182', 'geoPoint': {'lat': 33.86751, 'lon': -117.99812}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'BioSante Site #008', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'BioSante Site #007', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80239', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'BioSante Site #216', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06877', 'city': 'Ridgefield', 'state': 'Connecticut', 'country': 'United States', 'facility': 'BioSante Site #036', 'geoPoint': {'lat': 41.28148, 'lon': -73.49818}}, {'zip': '20036', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'BioSante Site #013', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'BioSante Site #024', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33781', 'city': 'Pinellas Park', 'state': 'Florida', 'country': 'United States', 'facility': 'BioSante Site #219', 'geoPoint': {'lat': 27.8428, 'lon': -82.69954}}, {'zip': '33709', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'BioSante Site #041', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33409', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'BioSante Site #009', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '60101', 'city': 'Addison', 'state': 'Illinois', 'country': 'United States', 'facility': 'BioSante Site #189', 'geoPoint': {'lat': 41.9317, 'lon': -87.98896}}, {'zip': '71115', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'BioSante Site #005', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '21285', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'BioSante Site #004', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'BioSante Site #044', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'BioSante Site #047', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '48604', 'city': 'Saginaw', 'state': 'Michigan', 'country': 'United States', 'facility': 'BioSante Site #033', 'geoPoint': {'lat': 43.41947, 'lon': -83.95081}}, {'zip': '48081', 'city': 'Saint Clair Shores', 'state': 'Michigan', 'country': 'United States', 'facility': 'BioSante Site #031', 'geoPoint': {'lat': 42.49698, 'lon': -82.88881}}, {'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'BioSante Site #208', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '55108', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'BioSante Site #198', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '59808', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'BioSante Site #051', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'zip': '68501', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'BioSante Site #006', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '89146', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'BioSante Site #217', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '12601', 'city': 'Poughkeepsie', 'state': 'New York', 'country': 'United States', 'facility': 'BioSante Site #015', 'geoPoint': {'lat': 41.70037, 'lon': -73.92097}}, {'zip': '27518', 'city': 'Cary', 'state': 'North Carolina', 'country': 'United States', 'facility': 'BioSante Site #059', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}, {'zip': '28209', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'BioSante Site #079', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'BioSante Site #061', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '58103', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'BioSante Site #056', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '44311', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'BioSante Site #210', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '45249', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'BioSante Site #212', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43212', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'BioSante Site #213', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'BioSante Site #050', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '15090', 'city': 'Wexford', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'BioSante Site #197', 'geoPoint': {'lat': 40.62646, 'lon': -80.05589}}, {'zip': '29201', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'BioSante Site #089', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '29651', 'city': 'Greer', 'state': 'South Carolina', 'country': 'United States', 'facility': 'BioSante Site #209', 'geoPoint': {'lat': 34.93873, 'lon': -82.22706}}, {'zip': '29926', 'city': 'Hilton Head Island', 'state': 'South Carolina', 'country': 'United States', 'facility': 'BioSante Site #097', 'geoPoint': {'lat': 32.19382, 'lon': -80.73816}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'BioSante Site #038', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '57201', 'city': 'Watertown', 'state': 'South Dakota', 'country': 'United States', 'facility': 'BioSante Site #049', 'geoPoint': {'lat': 44.89941, 'lon': -97.11507}}, {'zip': '37620', 'city': 'Bristol', 'state': 'Tennessee', 'country': 'United States', 'facility': 'BioSante Site #093', 'geoPoint': {'lat': 36.59511, 'lon': -82.18874}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'BioSante Site #069', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'BioSante Site #078', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'BioSante Site #042', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'BioSante Site #048', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78414', 'city': 'Corpus Christi', 'state': 'Texas', 'country': 'United States', 'facility': 'BioSante Site #073', 'geoPoint': {'lat': 27.80058, 'lon': -97.39638}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'BioSane Site #220', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'BioSante Site #039', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'BioSante Site #211', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84123', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'BioSante Site #218', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '05495', 'city': 'Williston', 'state': 'Vermont', 'country': 'United States', 'facility': 'BioSante Site #096', 'geoPoint': {'lat': 44.43755, 'lon': -73.06818}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'BioSante Site #003', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'BioSante Site #086', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '23294', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'BioSante Site #053', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '23456', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'BioSante Site #090', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}, {'zip': '98043', 'city': 'Mountlake Terrace', 'state': 'Washington', 'country': 'United States', 'facility': 'BioSante Site #083', 'geoPoint': {'lat': 47.78815, 'lon': -122.30874}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'BioSante Site #181', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': 'N7T 4X3', 'city': 'Sarnia', 'state': 'Ontario', 'country': 'Canada', 'facility': 'BioSante Site #188', 'geoPoint': {'lat': 42.97866, 'lon': -82.40407}}, {'zip': 'N8W5L7', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'BioSante Site #054', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'zip': 'G9N 2H6', 'city': 'Shawinigan', 'state': 'Quebec', 'country': 'Canada', 'facility': 'BioSante Site #193', 'geoPoint': {'lat': 46.56675, 'lon': -72.74913}}], 'overallOfficials': [{'name': 'Michael C Snabes, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'BioSante Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioSante Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}