Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT00195520
Status:
COMPLETED
Last Update Posted:
2008-08-05
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Evaluating Totelle® in Menopausal Symptoms and Sexual Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019584', 'term': 'Hot Flashes'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-08-01', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2008-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the tolerability, bleedeing patterns and acceptability of Totelle 1mg administered to a population of Brazilian women in a continuous combined regime for hormone replacement therapy.'}], 'secondaryOutcomes': [{'measure': 'To evaluate the effects of Totelle 1 mg on sexual function and quality of life.'}]}, 'conditionsModule': {'keywords': ['Menopause', 'Sleep Disorder', 'Hot Flashes'], 'conditions': ['Hot Flashes', 'Sleep Disorders']}, 'descriptionModule': {'briefSummary': 'To evaluate the tolerability, bleeding patterns and acceptability of Totelle® 1mg administered to a population of Brazilian women in a continuous combined regime for hormone replacement therapy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intact uterus\n* Generally health postmenopausal women 45 to 60 years of age, inclusive\n* Sexually active\n* No hormone replacement therapy within the 90 days immediately prior to the screening evaluation.\n\nExclusion Criteria:\n\n* Known or suspect estrogen-dependent neoplasia\n* Known hypersensitivity to estrogens, progestins, or other ingredients of Totelle\n* Use of any estrogen, progestin, androgen containing medications or tibolone within 12 weeks before screening.'}, 'identificationModule': {'nctId': 'NCT00195520', 'briefTitle': 'Study Evaluating Totelle® in Menopausal Symptoms and Sexual Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'An Open Assessment of the Effect of Low-Dose Totelle® 1 mg on Menopausal Symptoms, Sexual Function and Quality of Life', 'orgStudyIdInfo': {'id': '0753T-101537'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Totelle®', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13209-000', 'city': 'Jundiaí', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.18639, 'lon': -46.88417}}, {'zip': '04062-003', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wyeth is now a wholly owned subsidiary of Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}}}}