Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-25 @ 7:44 PM
Study NCT ID:
NCT00630435
Status:
COMPLETED
Last Update Posted:
2009-02-04
First Post:
2008-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Comparing 3 New Formulations of Premarin® 0.625 mg/MPA 2.5 mg With a Reference Formulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-03', 'studyFirstSubmitDate': '2008-02-28', 'studyFirstSubmitQcDate': '2008-03-06', 'lastUpdatePostDateStruct': {'date': '2009-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma concentrations of Premarin® and medroxyprogesterone acetate between test and currently marketed formulations', 'timeFrame': '14 weeks'}], 'secondaryOutcomes': [{'measure': 'No secondary outcome', 'timeFrame': 'No time frame'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Premarin®'], 'conditions': ['Menopause']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to determine the equivalence of 3 new formulations of a Premarin®/medroxyprogesterone acetate (MPA) combination tablet to the currently marketed dosage form (Prempro® \\[TM\\]). This study will be performed in healthy postmenopausal women. Each subject will participate in the study for approximately 14 weeks, including a screening evaluation within 3 weeks before the study, and four, 6-day, 5-night inpatient periods with at least a 21-day washout interval between each dose administration.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion\n\n1. Healthy postmenopausal women aged 35 to 70.\n2. Body mass index of 18 to 35 kg/m2, weight must be at least 50 kg.\n3. Nonsmoker or smoker of fewer than 10 cigarettes/day.\n\nExclusion\n\n1. History or presence of hypertension (\\>139 mm Hg systolic or \\>89 mm Hg diastolic). Can take up to 2 antihypertensive medications to keep blood pressure under control.\n2. History within 1 year of study day 1 of alcohol or drug abuse.\n3. Use of any investigational drug within 30 days before study day 1.'}, 'identificationModule': {'nctId': 'NCT00630435', 'briefTitle': 'Study Comparing 3 New Formulations of Premarin® 0.625 mg/MPA 2.5 mg With a Reference Formulation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioequivalence Study of 3 New Formulations of Premarin® /MPA 0.625 mg/2.5 mg Compared With Reference Formulation of Premarin®/MPA in Healthy Postmenopausal Women', 'orgStudyIdInfo': {'id': '0713E1-1137'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Premarin®/MPA formulation A']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: Premarin®/MPA formulation B']}, {'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Drug: Premarin®/MPA formulation C']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'interventionNames': ['Drug: Premarin®/MPA currently marketed product']}], 'interventions': [{'name': 'Premarin®/MPA formulation A', 'type': 'DRUG', 'armGroupLabels': ['1']}, {'name': 'Premarin®/MPA formulation B', 'type': 'DRUG', 'armGroupLabels': ['2']}, {'name': 'Premarin®/MPA formulation C', 'type': 'DRUG', 'armGroupLabels': ['3']}, {'name': 'Premarin®/MPA currently marketed product', 'type': 'DRUG', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'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'}, 'responsibleParty': {'oldNameTitle': 'Wyeth (Registry Contact: Clinical Trial Registry Specialist)', 'oldOrganization': 'Wyeth'}}}}