Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2026-02-17 @ 5:31 PM
Study NCT ID:
NCT02483195
Status:
WITHDRAWN
Last Update Posted:
2016-09-02
First Post:
2015-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of 5mg Finasteride Versus 200mg Spironolactone and Topical 5% Minoxidil in Treating Postmenopausal Female Androgenetic Alopecia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000505', 'term': 'Alopecia'}], 'ancestors': [{'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008914', 'term': 'Minoxidil'}, {'id': 'D013148', 'term': 'Spironolactone'}, {'id': 'D018120', 'term': 'Finasteride'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D001378', 'term': 'Azasteroids'}, {'id': 'D013260', 'term': 'Steroids, Heterocyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI indicating she was withdrawing her study submission due to lack of funding as of 6/20/2016', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-31', 'studyFirstSubmitDate': '2015-06-24', 'studyFirstSubmitQcDate': '2015-06-24', 'lastUpdatePostDateStruct': {'date': '2016-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Savin Scale will be used to determine hair growth and/or hair loss between the groups.', 'timeFrame': 'Change at 0, 4, 8, and 12 months', 'description': 'This will be based on a photographic scale from D1 to D8. With D1 being minimal disease and D8 being severe alopecia.'}, {'measure': 'The Ludwig Scale will be used to determine hair growth and/or hair loss between the groups.', 'timeFrame': 'Change at 0, 4, 8, and 12 months', 'description': 'This scale is based on the hair loss pattern. Ludwig Scale: Left = pattern 1, middle = pattern 2, right = pattern 3'}, {'measure': 'Alopecia improvement assessment will be used to determine hair growth and/or hair loss between the groups.', 'timeFrame': 'Change at 0, 4, 8, and 12 months', 'description': 'The value will be one of 7 numbers, ranging from -3 to +3. The values will stand for the following:\n\n* 3: markedly worsened alopecia\n* 2: moderately worsened alopecia\n* 1: slightly worsened alopecia 0: no change in alopecia\n\n * 1: slightly improved alopecia\n * 2: moderately improved alopecia\n * 3: markedly improved alopecia'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hair loss', 'Post Menopausal'], 'conditions': ['Female Androgenetic Alopecia']}, 'descriptionModule': {'briefSummary': 'The investigators propose to conduct a head-to-head, randomized clinical trial to compare the effectiveness of Minoxidil with Spironolactone and Finasteride in treating postmenopausal females with Androgenetic Alopecia (AGA).', 'detailedDescription': 'Participants diagnosed with AGA will be randomized into one of the two treatment arms outlined below, and will take the assigned treatment for a total duration of 12 months. Medications will be dispensed by a nurse who is blinded to the participants within each treatment group. Global photograph assessment and participant questionnaires at 0, 4, 8 and 12 months will be the primary means to determine improvement in hair loss.\n\nCompare the following interventions in treating postmenopausal female AGA:\n\nA) Combination 5% Minoxidil and 200mg Spironolactone (Combination Group) B) 5mg Finasteride with placebo topical preparation (Single Group)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female\n* postmenopausal (\\>60 years old or with total hysterectomy)\n* diagnosed with androgenetic alopecia\n* no chemical processing or changes in hair products throughout the study\n\nExclusion Criteria:\n\n* men\n* premenopausal women (\\<60 or without hysterectomy)\n* participants allergic to any of the study medications (minoxidil, finasteride, spironolactone)\n* participants with other co-existing forms of alopecia (traction, alopecia areata, or scarring alopecias)\n* participants with obstructive uropathy or advanced liver disease\n* prior hair loss treatment within the last 6 months\n* hair loss from the chemotherapy or other medication-induced alopecia\n* Hair loss for greater than 5 years, as medical therapy is unlikely to have much effect at restoring hair follicles inactive for that long of a period.'}, 'identificationModule': {'nctId': 'NCT02483195', 'briefTitle': 'The Use of 5mg Finasteride Versus 200mg Spironolactone and Topical 5% Minoxidil in Treating Postmenopausal Female Androgenetic Alopecia', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'The Use of 5mg Finasteride Versus 200mg Spironolactone and Topical 5% Minoxidil in Treating Postmenopausal Female Androgenetic Alopecia', 'orgStudyIdInfo': {'id': 'IRB201500433'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Combination Group', 'description': 'This group will use a mixed combination of 5% Minoxidil and 200mg Spironolactone for 12 months to be used once daily.', 'interventionNames': ['Drug: 5% Minoxidil', 'Drug: 200mg Spironolactone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Single Group', 'description': 'This group will use a mixed combination of 5mg Finasteride with placebo topical preparation for 12 months to be used once daily.', 'interventionNames': ['Drug: 5mg Finasteride', 'Other: Placebo']}], 'interventions': [{'name': '5% Minoxidil', 'type': 'DRUG', 'otherNames': ['Rogaine®', 'Theroxidil®', 'Minoxidil Topical'], 'description': 'This will be a mixed combination of 5% Minoxidil and 200mg Spironolactone to be used once daily.', 'armGroupLabels': ['Combination Group']}, {'name': '200mg Spironolactone', 'type': 'DRUG', 'otherNames': ['Aldactone®'], 'description': 'This will be a mixed combination of 5% Minoxidil and 200mg Spironolactone to be used once daily.', 'armGroupLabels': ['Combination Group']}, {'name': '5mg Finasteride', 'type': 'DRUG', 'otherNames': ['Propecia®', 'Proscar®'], 'description': 'This will be a mixed combination of 5mg Finasteride with placebo topical preparation to be used once daily.', 'armGroupLabels': ['Single Group']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['placebo topical preparation'], 'description': 'This will be a mixed combination of 5mg Finasteride with placebo topical preparation to be used once daily.', 'armGroupLabels': ['Single Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF Health', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Christina L. Mitchell, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}