Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-29 @ 2:07 PM
Study NCT ID:
NCT00857168
Status:
COMPLETED
Last Update Posted:
2009-10-14
First Post:
2009-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Determine the Effects of Deodorant, Antiperspirant and Washing on the Pharmacokinetics of 2% Testosterone MD Lotion
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-12', 'studyFirstSubmitDate': '2009-03-05', 'studyFirstSubmitQcDate': '2009-03-05', 'lastUpdatePostDateStruct': {'date': '2009-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the impact of application of antiperspirant and deodorant on absorption of testosterone, when applied pre-application of Testosterone MD-Lotion® (cutaneous solution). Also to evaluate the impact of washing.', 'timeFrame': 'April 2009'}], 'secondaryOutcomes': [{'measure': 'To assess the safety and tolerability of Testosterone MD-Lotion® (cutaneous solution) following single dose application.', 'timeFrame': 'April 2009'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypogonadism']}, 'descriptionModule': {'briefSummary': 'Testosterone replacement treatment is the most effective way of treating hypogonadism in men.\n\nAcrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study will evaluate the impact of application of antiperspirant and deodorant on absorption of testosterone, when applied pre-application of Testosterone MD-Lotion® (cutaneous solution).\n\nThe study also aim to evaluate the impact of washing the application site on the absorption of testosterone, when washed post-application of Testosterone MD-Lotion® (cutaneous solution).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy premenopausal female subjects ≥18 and ≤45 years of age with qualifying general medical health.\n\nExclusion Criteria:\n\n* Disqualifying concurrent condition or allergy/sensitivity to testosterone replacement therapy.'}, 'identificationModule': {'nctId': 'NCT00857168', 'acronym': 'MTE10', 'briefTitle': 'To Determine the Effects of Deodorant, Antiperspirant and Washing on the Pharmacokinetics of 2% Testosterone MD Lotion', 'organization': {'class': 'INDUSTRY', 'fullName': 'Acrux DDS Pty Ltd'}, 'officialTitle': 'A Phase I Trial to Determine the Impact of Application of Antiperspirant and Deodorant as Well as Washing the Application Site, on the Pharmacokinetics of Testosterone Following Single Dose Applications of 2% Testosterone MD-Lotion® (Cutaneous Solution)', 'orgStudyIdInfo': {'id': 'MTE10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'interventionNames': ['Drug: Testosterone MD-Lotion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'interventionNames': ['Drug: Testosterone MD-Lotion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3', 'interventionNames': ['Drug: Testosterone MD-Lotion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 4', 'interventionNames': ['Drug: Testosterone MD-Lotion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 5', 'interventionNames': ['Drug: Testosterone MD-Lotion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 6', 'interventionNames': ['Drug: Testosterone MD-Lotion']}], 'interventions': [{'name': 'Testosterone MD-Lotion', 'type': 'DRUG', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4', 'Group 5', 'Group 6']}]}, 'contactsLocationsModule': {'locations': [{'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 Devleopment', 'oldOrganization': 'Acrux Pharma Pty Ltd'}}}}