Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-03-16 @ 1:22 PM
Study NCT ID:
NCT00141557
Status:
TERMINATED
Last Update Posted:
2008-04-11
First Post:
2005-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D042724', 'term': 'Estrogens, Esterified (USP)'}, {'id': 'D008777', 'term': 'Methyltestosterone'}], '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': 'D013739', 'term': 'Testosterone'}, {'id': 'D000737', 'term': 'Androstenols'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}}, 'statusModule': {'whyStopped': 'Lack of enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-10', 'studyFirstSubmitDate': '2005-08-30', 'studyFirstSubmitQcDate': '2005-08-30', 'lastUpdatePostDateStruct': {'date': '2008-04-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in the total score of the Menopause Rating Scale (MRS)', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in the domain and individual item scores of the MRS', 'timeFrame': '12 weeks'}, {'measure': 'Change from baseline in the domain scores of the MENQOL', 'timeFrame': 'monthly for 3 months'}, {'measure': 'Comparison of changes in hormone levels and correlation with changes in the MRS', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Menopause; Postmenopause; Estrogen; Hormone Therapy'], 'conditions': ['Menopause']}, 'descriptionModule': {'briefSummary': 'To determine whether treatment with ESTRATEST® Tablets is superior to treatment with esterified estrogens tablets'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nHysterectomized, menopausal women between the ages of 30 and 65 years of age (inclusive) with symptoms of estrogen and/or androgen deficiency not currently controlled by estrogen therapy as determined by patient report and the Investigator's clinical judgement"}, 'identificationModule': {'nctId': 'NCT00141557', 'briefTitle': 'The Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Solvay Pharmaceuticals'}, 'officialTitle': 'A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women', 'orgStudyIdInfo': {'id': 'S030.2.110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: esterified estrogens 1.25mg and methyltestosterone 2.5mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Esterified estrogens 1.25 mg']}], 'interventions': [{'name': 'esterified estrogens 1.25mg and methyltestosterone 2.5mg', 'type': 'DRUG', 'description': 'ESTRATEST® administered orally QD', 'armGroupLabels': ['1']}, {'name': 'Esterified estrogens 1.25 mg', 'type': 'DRUG', 'description': 'Esterified estrogens 1.25 mg administered orally QD', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Site 66', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Site 57', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'facility': 'Site 46', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Site 29', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Site 15', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 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