Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-31 @ 10:51 AM
Study NCT ID:
NCT00998933
Status:
COMPLETED
Last Update Posted:
2009-11-25
First Post:
2009-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007006', 'term': 'Hypogonadism'}], 'ancestors': [{'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-24', 'studyFirstSubmitDate': '2009-10-20', 'studyFirstSubmitQcDate': '2009-10-20', 'lastUpdatePostDateStruct': {'date': '2009-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic Parameters Total Testosterone AUC, Cav, Cmax', 'timeFrame': '4 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Testosterone replacement therapy'], 'conditions': ['Hypogonadism']}, 'referencesModule': {'references': [{'pmid': '22188558', 'type': 'DERIVED', 'citation': 'Stahlman J, Britto M, Fitzpatrick S, McWhirter C, Testino SA, Brennan JJ, Zumbrunnen TL. Serum testosterone levels in non-dosed females after secondary exposure to 1.62% testosterone gel: effects of clothing barrier on testosterone absorption. Curr Med Res Opin. 2012 Feb;28(2):291-301. doi: 10.1185/03007995.2011.652732. Epub 2012 Jan 24.'}]}, 'descriptionModule': {'briefSummary': 'To further characterize the transfer potential of marketed testosterone gel and new 1.62% formulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and female volunteers, with a BMI 20-35 kg/m2 (males) and 20-30 kg/m2 (females).\n\nExclusion Criteria:\n\n* Males: history, current or suspected prostate or breast cancer.\n* Female: pregnant or lactating.'}, 'identificationModule': {'nctId': 'NCT00998933', 'briefTitle': 'Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Solvay Pharmaceuticals'}, 'officialTitle': 'An Open-label Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure to Testosterone Gel 1.62%', 'orgStudyIdInfo': {'id': 'S176.1.009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Testosterone gel 1.62%']}], 'interventions': [{'name': 'Testosterone gel 1.62%', 'type': 'DRUG', 'description': '5 grams applied topically to upper arms/shoulder and abdomen on Day 1', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Miami Gardens', 'state': 'Florida', 'country': 'United States', 'facility': 'Site 1', 'geoPoint': {'lat': 25.94204, 'lon': -80.2456}}], 'overallOfficials': [{'name': 'Global Clinical Director Solvay', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Solvay Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Solvay Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Barbara Parker', 'oldOrganization': 'Solvay Pharmaceuticals'}}}}