Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT00272935
Status:
COMPLETED
Last Update Posted:
2012-07-03
First Post:
2006-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Demonstrate the Efficacy and Safety of Cenestin 0.3 mg for the Treatment of Hot Flashes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019584', 'term': 'Hot Flashes'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C509653', 'term': 'estrogens, conjugated synthetic A'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-29', 'studyFirstSubmitDate': '2006-01-04', 'studyFirstSubmitQcDate': '2006-01-04', 'lastUpdatePostDateStruct': {'date': '2012-07-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change in average frequency of moderate to severe hot flashes', 'timeFrame': 'Baseline to Day 28 and to Day 84'}, {'measure': 'Mean change in severity of moderate to severe hot flashes', 'timeFrame': 'Baseline to Day 28 and to Day 84'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability of Cenestin 0.3mg', 'timeFrame': 'Throughout study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['menopause', 'vasomotor symptoms'], 'conditions': ['Hot Flashes']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind study to compare the efficacy and safety of daily doses of Cenestin 0.3 mg tablets to placebo in reducing the frequency and severity of moderate to severe hot flashes in postmenopausal women.', 'detailedDescription': 'The overall study duration will be approximately 16 weeks. After a screening/baseline period of up to 4 weeks patients will be randomized to receive either placebo tablets or Cenestin 0.3mg tablets'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Naturally or surgically postmenopausal\n* At least 12 months since last menses or 6 weeks past surgery\n* Minimum of 7 daily or 50 weekly moderate to severe hot flashes\n\nExclusion Criteria:\n\n* Any contraindication to natural or synthetic estrogens'}, 'identificationModule': {'nctId': 'NCT00272935', 'briefTitle': 'A Clinical Trial to Demonstrate the Efficacy and Safety of Cenestin 0.3 mg for the Treatment of Hot Flashes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A Randomized, Multicenter, Double-blind, Placebo-controlled Trial to Demonstrate the Safety and Efficacy of Daily 0.3 mg Synthetic Conjugated Estrogens, A (Cenestin) for the Treatment of Vasomotor Symptoms in Postmenopausal Women', 'orgStudyIdInfo': {'id': 'BR-CEN-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Cenestin 0.3 mg Tablets']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Cenestin 0.3 mg Tablets', 'type': 'DRUG', 'otherNames': ['Synthetic conjugated estrogens, A'], 'description': '1 tablet daily', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Placebo tablets'], 'description': '1 tablet daily', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '36116', 'city': 'Montgomery', 'state': 'Alabama', 'country': 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