Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-27 @ 8:45 PM
Study NCT ID:
NCT00425568
Status:
COMPLETED
Last Update Posted:
2018-08-08
First Post:
2007-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transdermal Testosterone Gel/Effect on Erection Quality as Measured by DIR
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013739', 'term': 'Testosterone'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'lastUpdateSubmitDate': '2018-08-07', 'studyFirstSubmitDate': '2007-01-20', 'studyFirstSubmitQcDate': '2007-01-22', 'lastUpdatePostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-01-23', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['hypogonadism', 'low testosterone level', 'gonadal deficiency'], 'conditions': ['Hypogonadism']}, 'descriptionModule': {'briefSummary': 'Low testosterone may be responsible for "soft" erections in men. The purpose of our study is to see whether the daily application of a testosterone gel to raise testosterone levels will also increase the "hardness" of a man\'s erection.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Testosterone \\<350 ng/dL,\n* 21-59 years of age,\n* BMI \\<30\n\nExclusion Criteria:\n\n* Those with carcinoma of the breast or known or suspected carcinoma of the prostate or with known hypersensitivity to any of the ingredients in AndroGel.\n* Men will be excluded if they have unstable angina, hypertension, diabetes, heart failure, or coronary artery disease.\n* Men will agree to discontinue use of current testosterone replacement, as well as Viagra or any other PDE5 inhibitors for 30 days.'}, 'identificationModule': {'nctId': 'NCT00425568', 'briefTitle': 'Transdermal Testosterone Gel/Effect on Erection Quality as Measured by DIR', 'organization': {'class': 'INDIV', 'fullName': 'Lamm, Steven, M.D.'}, 'officialTitle': 'Phase I Study of Transdermal Testosterone Gel and Its Effect on Erection Quality as Measured by a Digital Inflection Rigidometer (DIR)', 'orgStudyIdInfo': {'id': 'DIR1-SLGSC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'AndroGel (Transdermal Testosterone Gel)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10028', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Steven Lamm, M.D.', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Steven Lamm, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lamm, Steven, M.D.', 'class': 'INDIV'}, 'collaborators': [{'name': 'Solvay Pharmaceuticals', 'class': 'INDUSTRY'}]}}}