Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 12:03 AM
Study NCT ID:
NCT00224094
Status:
COMPLETED
Last Update Posted:
2012-10-15
First Post:
2005-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparison of Patch vs. Pill Estrogen Therapy on Testosterone Levels and Thyroid Tests in Menopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004966', 'term': 'Estrogens, Conjugated (USP)'}, {'id': 'D000279', 'term': 'Administration, Cutaneous'}], 'ancestors': [{'id': 'D045166', 'term': 'Estradiol 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'}, {'id': 'D000287', 'term': 'Administration, Topical'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'lastUpdateSubmitDate': '2012-10-11', 'studyFirstSubmitDate': '2005-09-14', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2012-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the effects of a 12-week course of oral CEE to a 12-week course of transdermal estradiol on free testosterone concentrations in menopausal women.', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Compare the effects of oral versus transdermal ERT on thyroid binding globulin concentrations and tests of thyroid function.', 'timeFrame': '12 weeks'}, {'measure': 'Compare the effects of oral versus transdermal ERT on cortisol binding globulin and total and free cortisol concentrations.', 'timeFrame': '12 weeks'}]}, 'conditionsModule': {'keywords': ['Menopause', 'Testosterone', 'Androgens', 'Sex Hormone Binding Globulin', 'Thyroid function', 'Cortisol'], 'conditions': ['Menopause']}, 'descriptionModule': {'briefSummary': 'This study compares the effects of 12 weeks of treatment with transdermal versus oral estrogen therapy on testsoterone levels and thyroid tests in healthy, naturally menopausal women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '42 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Naturally menopausal women\n* Aged 42-70 years\n* Currently using combination estrogen-progestin replacement therapy\n\nExclusion Criteria:\n\n* Women with contraindications to HRT use, including:Unexplained vaginal bleeding, liver disease, breast or endometrial cancer, venous thromboembolic events\n* Thyroid disease\n* Adrenal disease'}, 'identificationModule': {'nctId': 'NCT00224094', 'briefTitle': 'A Comparison of Patch vs. Pill Estrogen Therapy on Testosterone Levels and Thyroid Tests in Menopausal Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Watson Pharmaceuticals'}, 'officialTitle': 'A Comparison of Transdermal vs. Oral Estrogen Replacement Therapy on Androgen Levels and Thyroid Function in Naturally Menopausal Women', 'orgStudyIdInfo': {'id': 'ALO0102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence A', 'description': 'Oral ERT then transdermal ERT', 'interventionNames': ['Drug: Premarin® (oral) vs. Alora® (transdermal)']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence B', 'description': 'Transdermal ERT then oral ERT', 'interventionNames': ['Drug: Premarin® (oral) vs. Alora® (transdermal)']}], 'interventions': [{'name': 'Premarin® (oral) vs. Alora® (transdermal)', 'type': 'DRUG', 'armGroupLabels': ['Sequence A', 'Sequence B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Jan L Shifren, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Watson Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Massachusetts General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}