Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-29 @ 9:51 PM
Study NCT ID:
NCT01291004
Status:
COMPLETED
Last Update Posted:
2021-12-08
First Post:
2011-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Ovarian Follicular Activity and Hormone Levels for DR-102 Compared to Two 28-Day Oral Contraceptives
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017135', 'term': 'Desogestrel'}, {'id': 'D004997', 'term': 'Ethinyl Estradiol'}], 'ancestors': [{'id': 'D009652', 'term': 'Norpregnenes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D009651', 'term': 'Norpregnatrienes'}, {'id': 'D042782', 'term': 'Estrogenic Steroids, Alkylated'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 206}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2012-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-01', 'studyFirstSubmitDate': '2011-02-04', 'studyFirstSubmitQcDate': '2011-02-04', 'lastUpdatePostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of ovarian follicular development by the Hoogland and Skouby grading scale from baseline to week 16.', 'timeFrame': '16 weeks'}, {'measure': 'Change in serum Estradiol level from baseline to week 16.', 'timeFrame': '16 weeks'}, {'measure': 'Change in serum Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) levels from baseline to week 16.', 'timeFrame': '16 weeks'}, {'measure': 'Change in serum Progesterone level from baseline to week 20.', 'timeFrame': '20 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline to week 15 in Prothrombin fragment 1 + 2 levels.', 'timeFrame': '15 weeks'}, {'measure': 'Change from baseline to week 15 in D-dimer.', 'timeFrame': '15 weeks'}, {'measure': 'Change from baseline to end of week 15 in Plasmin-Antiplasmin complex', 'timeFrame': '15 weeks'}, {'measure': 'Change from baseline to week 15 in APTT and ETP based activated protein-C resistance (APC).', 'timeFrame': '15 weeks'}, {'measure': 'Change from baseline to week 15 in Fibrinogen.', 'timeFrame': '15 weeks'}, {'measure': 'Change from baseline to week 15 in Plasminogen, Factor II, Factor VII, Factor VIII, Protein C, and Free and Total Protein S.', 'timeFrame': '15 weeks'}, {'measure': 'Change from baseline to week 15 in Tissue Plasminogen Activator (t-PA).', 'timeFrame': '15 weeks'}, {'measure': 'Change from baseline to week 15 in Antithrombin.', 'timeFrame': '15 weeks'}, {'measure': 'Change from baseline to week 15 in Tissue Factor Pathway Inhibitor (TFPI).', 'timeFrame': '15 weeks'}, {'measure': 'Change from baseline to week 15 in Total Cortisol and Corticosteroid Binding Globulin (CBG).', 'timeFrame': '15 weeks'}, {'measure': 'Change from baseline to week 15 in Thyroid Stimulating Hormone (TSH).', 'timeFrame': '15 weeks'}, {'measure': 'Change from baseline to week 15 in Sex Hormone Binding Globulin (SHBG).', 'timeFrame': '15 weeks'}, {'measure': 'Return to ovulation rate at week 20.', 'timeFrame': 'Week 20'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Follicle Development', 'Ovarian Follicle', 'Follicle Count', 'Follicle Size', 'Oral Contraceptive']}, 'descriptionModule': {'briefSummary': 'This study is being conducted to evaluate the impact of a 28-day oral contraceptive compared to two 28-day oral contraceptive regimens containing different synthetic progestins on ovarian follicular activity and hormone levels in healthy women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Premenopausal, non-pregnant, non-lactating women age 18-35 years old\n* Body Mass Index (BMI) ≥18 kg/m² and \\<30 kg/m²\n* Regular spontaneous menstrual cycle\n* Others as dictated by Food and Drug Administration (FDA)-approved protocol\n\nExclusion Criteria:\n\n* Any condition which contraindicates the use of combination oral contraceptives\n* Known thrombophlebitis or thromboembolic disorders; known or suspected clotting disorders; thrombogenic valvulopathies or rhythm disorders\n* Migraine headaches with focal, neurological symptoms\n* Others as dictated by FDA-approved protocol'}, 'identificationModule': {'nctId': 'NCT01291004', 'briefTitle': 'A Study to Evaluate Ovarian Follicular Activity and Hormone Levels for DR-102 Compared to Two 28-Day Oral Contraceptives', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A Multicenter, Open-Label Study to Evaluate Ovarian Follicular Activity and Hormone Levels With the Oral Contraceptive Regimen DR-102 Compared to Two 28-day Oral Contraceptive Regimens Containing Different Synthetic Progestins', 'orgStudyIdInfo': {'id': 'DSG-OI-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '28-day Desogestrel Oral Contraceptive', 'interventionNames': ['Drug: Desogestrel/ethinyl estradiol and ethinyl estradiol']}, {'type': 'ACTIVE_COMPARATOR', 'label': '28-day Drospirenone Oral Contraceptive', 'interventionNames': ['Drug: 28-day drospirenone oral contraceptive']}, {'type': 'ACTIVE_COMPARATOR', 'label': '28-day Levonorgestrel Oral Contraceptive', 'interventionNames': ['Drug: 28-day levonorgestrel oral contraceptive']}], 'interventions': [{'name': 'Desogestrel/ethinyl estradiol and ethinyl estradiol', 'type': 'DRUG', 'description': 'Desogestrel/ethinyl estradiol 0.15/0.02 mg and ethinyl estradiol 0.01 mg tablet', 'armGroupLabels': ['28-day Desogestrel Oral Contraceptive']}, {'name': '28-day drospirenone oral contraceptive', 'type': 'DRUG', 'description': 'Drospirenone/ethinyl estradiol 0.3/0.02 mg', 'armGroupLabels': ['28-day Drospirenone Oral Contraceptive']}, {'name': '28-day levonorgestrel oral contraceptive', 'type': 'DRUG', 'description': 'Levonorgestrel/ethinyl estradiol 0.1/0.02 mg', 'armGroupLabels': ['28-day Levonorgestrel Oral Contraceptive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19114', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Teva Investigational Site 10119', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Teva Investigational Site 10118', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': "Teva Women's Health Research Protocol Chair", 'role': 'STUDY_CHAIR', 'affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Branded Pharmaceutical Products R&D, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}