Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-31 @ 7:18 AM
Study NCT ID:
NCT00941057
Status:
COMPLETED
Last Update Posted:
2016-08-01
First Post:
2009-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study: 2 mg Estradiol Valerate (EV) and 3 mg Dienogest (DNG) Without and With Levomefolate Calcium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C023635', 'term': 'dienogest'}, {'id': 'C569381', 'term': 'levomefolate calcium'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-29', 'studyFirstSubmitDate': '2009-07-16', 'studyFirstSubmitQcDate': '2009-07-16', 'lastUpdatePostDateStruct': {'date': '2016-08-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC', 'timeFrame': 'Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C', 'description': 'Area under the concentration vs time curve from zero to infinity for DNG'}, {'measure': 'Cmax', 'timeFrame': 'Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C', 'description': 'Maximum drug concentration for DNG and for E1, E2, E1S, and L-5-methyl-THF (baseline corrected and uncorrected)'}, {'measure': 'AUC(0-tlast)', 'timeFrame': 'Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C', 'description': 'AUC from time 0 to the last data point above the lower limit of quantitation for E1, E2, E1S, and L-5-methyl-THF (baseline corrected and uncorrected)'}], 'secondaryOutcomes': [{'measure': 'tmax', 'timeFrame': 'Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C', 'description': 'Time to reach maximum drug concentration in plasma for DNG and E1, E2, E1S, and L-5-methyl-THF (baseline uncorrected)'}, {'measure': 't½', 'timeFrame': 'Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C', 'description': 'Half-life associated with the terminal slope for DNG and E1, E2, E1S, and L-5-methyl-THF'}, {'measure': 'λz', 'timeFrame': 'Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C', 'description': 'Apparent terminal rate constant(estimates only) for DNG and E1, E2, E1S, and L-5-methyl-THF'}, {'measure': 'AUC(0-tlast)', 'timeFrame': 'Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C', 'description': 'AUC from time 0 to the last data point above the lower limit of quantitation for DNG'}, {'measure': 'AUC', 'timeFrame': 'Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C', 'description': 'Area under the concentration vs time curve from zero to infinity E1, E2, E1S, and L-5-methyl-THF (baseline corrected)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pharmacology, Clinical']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu/', 'label': 'Click here to find information about studies related to Bayer Healthcare products conducted in Europe.'}]}, 'descriptionModule': {'briefSummary': 'Investigation of the bioequivalence (BE) of Estradiol Valerate (EV) and Dienogest (DNG) after administration of one film-coated tablet containing 2 mg Estradiol Valerate, 3 mg Dienogest and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing 2 mg Estradiol Valerate,3 mg Dienogest.Investigation of the bioequivalence of levomefolate calcium after administration of one film-coated tablet containing 2 mg Estradiol Valerate, 3 mg Dienogest and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing 0.451 mg levomefolate calcium'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy postmenopausal women, age: 45-75 years with body mass index between ≥18 and ≤30 kg/m2. Post-menopausal state revealed by: medical history, and hormone analyses in serum: estradiol ≤20 pg/mL and in women \\<60 years old: follicle-stimulating hormone ≥ 40 IU/L at screening\n\nExclusion Criteria:\n\n* Contraindications for use of combined (Estradiolvalerate/Dienogest) contraceptive (e.g.history of venous/arterial thromboembolic disease)\n* Regular intake of medication\n* Clinically relevant findings (ECG, blood pressure, physical and gynaecological examination, laboratory examination)\n* Smoking'}, 'identificationModule': {'nctId': 'NCT00941057', 'briefTitle': 'Bioequivalence Study: 2 mg Estradiol Valerate (EV) and 3 mg Dienogest (DNG) Without and With Levomefolate Calcium', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Open-label, Randomized, Cross-over Study to Investigate the Bioequivalence of Estradiol Valerate (EV), Dienogest (DNG) and Levomefolate Calcium After Single Oral Administration of a Tablet Formulation Containing 2 mg Estradiol Valerate and 3 mg Dienogest Without and With 0.451 mg Levomefolate Calcium and a Tablet Formulation Containing 0.451 mg Levomefolate Calcium in 42 Healthy Postmenopausal Women', 'orgStudyIdInfo': {'id': '13469'}, 'secondaryIdInfos': [{'id': '2009-011963-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Estradiol + dienogest + levomefolate', 'description': 'Treatment A', 'interventionNames': ['Drug: BAY 98-7079, Estradiolvalerate (EV) / Dienogest (DNG) / Levomefolate calcium']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Estradiol + dienogest', 'description': 'Treatment B', 'interventionNames': ['Drug: BAY 86-5027,Estradiolvalerate(EV) / Dienogest (DNG)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Levomefolate', 'description': 'Treatment C', 'interventionNames': ['Drug: BAY 86-7660,levomefolate calcium']}], 'interventions': [{'name': 'BAY 98-7079, Estradiolvalerate (EV) / Dienogest (DNG) / Levomefolate calcium', 'type': 'DRUG', 'description': 'Oral, single dose, 2 mg EV + 3 mg DNG + 0.451 mg levomefolate calcium washout phase between treatments: at least 7 days', 'armGroupLabels': ['Estradiol + dienogest + levomefolate']}, {'name': 'BAY 86-5027,Estradiolvalerate(EV) / Dienogest (DNG)', 'type': 'DRUG', 'description': 'Oral, single dose, 2 mg EV + 3 mg DNG washout phase between treatments: at least 7 days', 'armGroupLabels': ['Estradiol + dienogest']}, {'name': 'BAY 86-7660,levomefolate calcium', 'type': 'DRUG', 'description': 'Oral, single dose, 0.451 mg levomefolate calcium washout phase between treatments: at least 7 days', 'armGroupLabels': ['Levomefolate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89231', 'city': 'Neu-Ulm', 'state': 'Bavaria', 'country': 'Germany', 'geoPoint': {'lat': 48.39279, 'lon': 10.01112}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}