Ignite Creation Date:
2025-12-24 @ 12:53 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT00193661
Status:
COMPLETED
Last Update Posted:
2015-01-16
First Post:
2005-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observation Study of T-Gel (1%) in Treatment of Adolescent Boys With Hypogonadism
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08'}, 'statusVerifiedDate': '2006-09', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-15', 'studyFirstSubmitDate': '2005-09-11', 'studyFirstSubmitQcDate': '2005-09-11', 'lastUpdatePostDateStruct': {'date': '2015-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Hypogonadism'], 'conditions': ['Primary or Secondary Hypogonadism', 'Constitutional Delay in Growth and Puberty (CDGP)']}, 'descriptionModule': {'briefSummary': 'This study is to observe efficacy and safety after T-Gel 1% treatment in delayed puberty adolescents. Subjects who complete this trial may enter a 3 month extension study (UMD-01-090E).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary or secondary hypogonadism or constitutional delay in growth and puberty (CDGP)\n\nExclusion Criteria:\n\n* Skin intolerance to alcohol or allergy to soy\n* Generalized skin disease\n* Contraindication to testosterone or androgen products'}, 'identificationModule': {'nctId': 'NCT00193661', 'briefTitle': 'Observation Study of T-Gel (1%) in Treatment of Adolescent Boys With Hypogonadism', 'organization': {'class': 'INDUSTRY', 'fullName': 'Solvay Pharmaceuticals'}, 'officialTitle': 'A Multi-Center, Open-Label, Observational Study of Testosterone Gel (1%) in the Treatment of Adolescent Boys With Hypogonadism', 'orgStudyIdInfo': {'id': 'UMD-01-090'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Testosterone Gel (1%)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Site 130', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Site 107', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Site 113', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Site 114', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Site 121', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Site 127', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Site 128', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Site 117', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Site 111', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Site 129', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Site 123', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Site 131', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Site 124', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Site 103', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Site 109', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Site 125', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Site 126', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Site 104', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Site 205', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Global Clinical Director Solvay', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Solvay Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Solvay Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Unimed Pharmaceuticals', 'class': 'INDUSTRY'}]}}}