Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT00996151
Status:
COMPLETED
Last Update Posted:
2010-03-02
First Post:
2009-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testosterone MD-Lotion Residual Washing Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-28', 'studyFirstSubmitDate': '2009-10-12', 'studyFirstSubmitQcDate': '2009-10-15', 'lastUpdatePostDateStruct': {'date': '2010-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The amount of Testerone MD-Lotion 2% remaining on the axilla after a single dose application in healthy males who undergo a post dose washing procedure.', 'timeFrame': 'March 2010'}], 'secondaryOutcomes': [{'measure': 'The safety and tolerability of Testosterone MD-Lotion 2% following a single dose application. This will be performed by review of adverse events, EKG and assessment of laboratory parameters (haematology, biochemistry, urinalysis and hormone levels).', 'timeFrame': 'March 2010'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypergonadism', 'Testosterone Transfer'], 'conditions': ['Hypergonadism']}, 'descriptionModule': {'briefSummary': 'The study will evaluate the amount of Testosteron MD-Lotion 2% remaining on the axilla after a single dose application in healthy males who undergo a post dose washing procedure.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subjects ≥18 and ≤ 70 years\n\nExclusion Criteria:\n\n* Disqualifying concurrent condition or allergy/sensitivity to Testosterone MD-Lotion'}, 'identificationModule': {'nctId': 'NCT00996151', 'acronym': 'MTE11', 'briefTitle': 'Testosterone MD-Lotion Residual Washing Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Acrux DDS Pty Ltd'}, 'officialTitle': 'A Healthy Volunteer, Single Dose Phase I Trial to Determine the Amount of Testerone MD-Lotion 2% Remaining on the Axilla After Washing.', 'orgStudyIdInfo': {'id': 'MTE11'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Testosterone MD-Lotion', 'type': 'DRUG', 'description': 'Single dose Testosterone MD-Lotion 2%'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4006', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'QPharm Pty Ltd', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}], 'overallOfficials': [{'name': 'Tina Soulis, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Acrux Pharma Pty Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acrux DDS Pty Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Tina Soulis, Director, Clinical Development', 'oldOrganization': 'Acrux Pharma Pty Ltd'}}}}