Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-25 @ 7:11 PM
Study NCT ID:
NCT01477632
Status:
COMPLETED
Last Update Posted:
2016-01-15
First Post:
2011-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioavailability of Three Oral Formulations for Hormone Replacement Therapy in Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D000077563', 'term': 'Norethindrone Acetate'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009640', 'term': 'Norethindrone'}, {'id': 'D009652', 'term': 'Norpregnenes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-14', 'studyFirstSubmitDate': '2011-11-18', 'studyFirstSubmitQcDate': '2011-11-18', 'lastUpdatePostDateStruct': {'date': '2016-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the curve (AUC(0-∞))'}, {'measure': 'Maximal concentration (Cmax)'}, {'measure': 'Time to maximum (tmax)'}], 'secondaryOutcomes': [{'measure': 'Area Under the Curve (AUC) from dosing up to last sample'}, {'measure': 'Terminal half-life (t½)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Menopause', 'Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe. The aim of this trial is to determine the extent of bioavailability of two low dose estradiol/norethisterone acetate (NETA) preparations with a marketed estradiol/norethisterone acetate (NETA) preparation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Postmenopausal\n* Caucasian race\n* Smoking (up to 5 cig./per day) is allowed\n* Good state of health: evidenced by medical history, physical examination including gynecological examination, results of laboratory examination\n\nExclusion Criteria:\n\n* Known or suspected allergy to trial products or related products\n* Previous participation in this trial\n* Previous estrogen and/or progestin hormone replacement therapy\n* Known, suspected or history of breast cancer\n* Systolic blood pressure (BP) at least 160 mm Hg and/or diastolic BP at least 100 mm Hg, currently treated or untreated\n* Body Mass Index (BMI) above 35.0 kg/m\\^2'}, 'identificationModule': {'nctId': 'NCT01477632', 'briefTitle': 'Bioavailability of Three Oral Formulations for Hormone Replacement Therapy in Postmenopausal Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Single Dose, Three-way, Cross-over, Relative Bioavailability Study With 3 Oral Formulations for Hormone Replacement Therapy in Postmenopausal Women: 0.5 mg Estradiol + 0.1 mg Norethisterone Acetate, 0.5 mg Estradiol + 0.25 mg Norethisterone Acetate, and 1.0 mg Estradiol + 0.5 mg Norethisterone Acetate', 'orgStudyIdInfo': {'id': 'ALD-1640'}, 'secondaryIdInfos': [{'id': '2004-002457-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'interventionNames': ['Drug: 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C', 'interventionNames': ['Drug: 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)']}], 'interventions': [{'name': '0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)', 'type': 'DRUG', 'description': 'A single oral dose of 2 tablets under fasting conditions', 'armGroupLabels': ['A']}, {'name': '0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)', 'type': 'DRUG', 'description': 'A single oral dose of 2 tablets under fasting conditions', 'armGroupLabels': ['B']}, {'name': '1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)', 'type': 'DRUG', 'description': 'A single oral dose of 1 tablet under fasting conditions', 'armGroupLabels': ['C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89231', 'city': 'Neu-Ulm', 'country': 'Germany', 'geoPoint': {'lat': 48.39279, 'lon': 10.01112}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}