Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-01-01 @ 10:30 AM
Study NCT ID:
NCT00729404
Status:
TERMINATED
Last Update Posted:
2014-12-02
First Post:
2008-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inhibition of Ovulation, Patch, Ethinylestradiol and Gestodene
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004997', 'term': 'Ethinyl Estradiol'}, {'id': 'C033273', 'term': 'Gestodene'}], 'ancestors': [{'id': 'D009651', 'term': 'Norpregnatrienes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-27', 'studyFirstSubmitDate': '2008-08-04', 'studyFirstSubmitQcDate': '2008-08-06', 'lastUpdatePostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3.', 'timeFrame': '4 month'}], 'secondaryOutcomes': [{'measure': 'Assessment of ovarian activity during treatment cycle2 and 3 (Hoogland score)', 'timeFrame': '4 month'}, {'measure': 'Course of gonadotropins (FSH, LH, P, E2)', 'timeFrame': '4 month'}, {'measure': 'Endometrial thickness', 'timeFrame': '4 month'}, {'measure': 'Follicle size', 'timeFrame': '4 month'}, {'measure': 'Pharmacokinetics of EE, GSD and SHBG in treatment cycles 2 and 3', 'timeFrame': '4 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Female Contraception', 'Ovulation Inhibition'], 'conditions': ['Contraception', 'Ovulation Inhibition']}, '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 two transdermal hormone patch formulations for contraception regarding inhibition of ovulation over a period of 3 treatment cycles in healthy young female volunteers', 'detailedDescription': 'Study was suspended due to inconclusive toxicology findings regarding the used patch formulation to be clarified prior to re-start of the study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent,\n* BMI: 18 - 30 kg/m²,\n* Healthy female volunteers,\n* Age 18-35 years (smoker not older than 30 years, inclusive),\n* Ovulatory pre-treatment cycle, at least 3 month since delivery,\n* Abortion or lactation before the first screening examination,\n* Willingness to use non-hormonal methods of contraception during entire study\n\nExclusion Criteria:\n\n* Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous/arterial thromboembolic disease\n* Regular intake of medication other than OCs\n* Clinically relevant findings (blood pressure, physical and gynaecological examination, laboratory examination)\n* Anovulatory pre-treatment cycle'}, 'identificationModule': {'nctId': 'NCT00729404', 'briefTitle': 'Inhibition of Ovulation, Patch, Ethinylestradiol and Gestodene', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Multicenter, Open-label, Randomized, Uncontrolled Study to Evaluate Inhibition of Ovulation of Two Transdermal Patch Formulations Containing 0.55 mg EE and Either 1.05 or 2.1 mg GSD in Healthy Young Female Vol. Over a Period of 3 Treatment Cycles', 'orgStudyIdInfo': {'id': '91558'}, 'secondaryIdInfos': [{'id': '2008-001198-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: Ethinylestradiol/Gestodene (BAY86-5016)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'interventionNames': ['Drug: Ethinylestradiol/Gestodene (BAY86-5016)']}], 'interventions': [{'name': 'Ethinylestradiol/Gestodene (BAY86-5016)', 'type': 'DRUG', 'description': 'transdermal patch: 0.55mg EE+2.1mg GSD; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles)', 'armGroupLabels': ['Arm 1']}, {'name': 'Ethinylestradiol/Gestodene (BAY86-5016)', 'type': 'DRUG', 'description': 'transdermal patch: 0.55mg EE+1.05 mg GSD; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10115', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10707', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13342', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}