Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-01-03 @ 2:36 AM
Study NCT ID:
NCT00543634
Status:
COMPLETED
Last Update Posted:
2010-06-22
First Post:
2007-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017258', 'term': 'Medroxyprogesterone Acetate'}], 'ancestors': [{'id': 'D008525', 'term': 'Medroxyprogesterone'}, {'id': 'D006908', 'term': 'Hydroxyprogesterones'}, {'id': 'D011374', 'term': 'Progesterone'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-17', 'studyFirstSubmitDate': '2007-10-03', 'studyFirstSubmitQcDate': '2007-10-11', 'lastUpdatePostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma concentration data and pharmacokinetic (PK) parameters of MPA and Premarin® (estrone, equilin and MPA).', 'timeFrame': '4 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Postmenopause']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the safety and efficacy of new tablet formulations of Premarin®/medroxyprogesterone (MPA).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '* Healthy postmenopausal women aged 35 to 70 years with spontaneous or surgical amenorrhea\n* BMI in the range of 18 to 35 kg/m2\n* History or presence of hypertension (\\>139 mm Hg systolic or \\>89 mm Hg diastolic)\n* History of drug allergy, particularly to conjugated estrogens (CE) or selective estrogen receptor modulators (SERMs)\n* Use of any prescription or investigational drug within 30 days before test article administration'}, 'identificationModule': {'nctId': 'NCT00543634', 'briefTitle': 'Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'Open-Label, Single-Dose, Partially Randomized, 6-Period, 6-Treatment, Crossover Bioavailability Study of 3 Pilot Formulations of Premarin®/Medroxyprogesterone Acetate (MPA) Compared With Reference Formulations of Premarin®/MPA (PREMPRO®) and MPA Suspension (Provera®) in Healthy Postmenopausal Women', 'orgStudyIdInfo': {'id': '0713E1-1138'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: Premarin/MPA']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Provera 10 mg']}], 'interventions': [{'name': 'Premarin/MPA', 'type': 'DRUG', 'description': '0.625 mg/2.5 mg X4', 'armGroupLabels': ['1']}, {'name': 'Premarin/MPA', 'type': 'DRUG', 'description': '0.625 mg/5 mg X 2', 'armGroupLabels': ['1']}, {'name': 'Provera 10 mg', 'type': 'DRUG', 'description': '2.5 mg of MPA, 4 tablets dissoved in water', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68154', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', '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'}, 'collaborators': [{'name': 'MDS Pharma Services', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Wyeth'}}}}