Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-27 @ 11:51 AM
Study NCT ID:
NCT01172366
Status:
COMPLETED
Last Update Posted:
2010-09-06
First Post:
2010-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Potential for Interpersonal Transfer of Testosterone Following Single Dose Application
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': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-02', 'studyFirstSubmitDate': '2010-07-28', 'studyFirstSubmitQcDate': '2010-07-28', 'lastUpdatePostDateStruct': {'date': '2010-09-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics', 'timeFrame': '72 hours total', 'description': 'Single dose pharmacokinetic parameters (AUC0-24, AUC0-72, Cmin, Cmax, and tmax) are to be reported for total testosterone, free testosterone and DHT.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Open label, single dose, pharmacokinetic study'], 'conditions': ['Hypogonadism']}, 'descriptionModule': {'briefSummary': 'The hypotheses for this study is that there is no transfer of testosterone from male (donor) subjects to female (recipient) subjects when contact is made 2 hours post application of 2% Testosterone MD-Lotion® if the donor has a covered application area with a T-shirt.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy male and female volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Healthy Male Subjects:\n\nInclusion:\n\n* Healthy male subjects aged ≥ 18 and ≤ 45, who have no history of clinically significant medical disorders and who have passed the required laboratory and physical screening tests.\n\nExclusion:\n\n* Men with a history of allergy/sensitivity to testosterone or in whom testosterone therapy is contraindicated, or a clinically significant finding on physical exam or skin disorder.\n\nHealthy Female Subjects:\n\nInclusion:\n\n* Healthy premenopausal women aged ≥ 18 and ≤ 45, who have no history of clinically significant medical disorders and who have passed the required laboratory and physical screening tests.\n\nExclusion:\n\n* Women with a history of allergy/sensitivity to testosterone or in whom testosterone therapy is contraindicated, or a clinically significant finding on physical exam or skin disorder.'}, 'identificationModule': {'nctId': 'NCT01172366', 'briefTitle': 'A Study to Evaluate the Potential for Interpersonal Transfer of Testosterone Following Single Dose Application', 'organization': {'class': 'INDUSTRY', 'fullName': 'Acrux DDS Pty Ltd'}, 'officialTitle': 'A Phase I Study to Evaluate the Potential for Interpersonal Transfer of Testosterone Following Single Dose Application of 2% Testosterone Metered Dose (MD) Lotion®', 'orgStudyIdInfo': {'id': 'MTE12'}}, 'contactsLocationsModule': {'locations': [{'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'QPharm', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}], 'overallOfficials': [{'name': 'Tina Soulis, BSc, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Acrux DDS Pty Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acrux DDS Pty Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Development', 'oldOrganization': 'Acrux DDS Pty Ltd'}}}}