Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-27 @ 11:18 PM
Study NCT ID:
NCT00924560
Status:
COMPLETED
Last Update Posted:
2014-10-22
First Post:
2009-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Multicenter Study to Evaluate the Effects of a 91-day Oral Contraceptive on Bone Mineral Density in Adolescent Females
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019304', 'term': 'Ethinyl Estradiol-Norgestrel Combination'}, {'id': 'C000606708', 'term': 'Seasonique'}], 'ancestors': [{'id': 'D004997', 'term': 'Ethinyl Estradiol'}, {'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': 'D009644', 'term': 'Norgestrel'}, {'id': 'D009652', 'term': 'Norpregnenes'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ustevatrials@tevapharm.com', 'phone': '215-591-3000', 'title': 'Director, Clinical Research', 'organization': 'Teva Branded Pharmaceutical Products, R&D Inc.'}, 'certainAgreement': {'otherDetails': "Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 months', 'description': 'The safety analysis set includes data from all randomly assigned participants who received at least 1 dose of study treatment and from all participants enrolled in the control group who had baseline BMD measures via DXA. One participant randomly assigned to 91-day LNG received 21-day LNG instead and is included in the 21-day LNG group for safety.', 'eventGroups': [{'id': 'EG000', 'title': '91-day Levonorgestrel OC', 'description': 'Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).', 'otherNumAtRisk': 421, 'otherNumAffected': 156, 'seriousNumAtRisk': 421, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': '28-day Levonorgestrel OC', 'description': 'Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets (containing 100 μg LNG/20 μg EE) followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).', 'otherNumAtRisk': 412, 'otherNumAffected': 160, 'seriousNumAtRisk': 412, 'seriousNumAffected': 12}, {'id': 'EG002', 'title': 'Untreated Control', 'description': 'Participants received no oral contraceptives during the study.', 'otherNumAtRisk': 437, 'otherNumAffected': 196, 'seriousNumAtRisk': 437, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 28, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 46, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 62, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 91, 'numAffected': 53}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 44, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 32, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 79, 'numAffected': 53}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 17, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 26, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 26, 'numAffected': 22}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 124, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 120, 'numAffected': 69}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 197, 'numAffected': 88}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 31, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 41, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 88, 'numAffected': 37}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 40, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 21, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 35, 'numAffected': 30}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Wolff-Parkinson-White syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Serositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Clostridial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hepatitis infectious mononucleosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Post concussion syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Knee deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abortion incomplete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Affective disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Drug abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Drug dependence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 412, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 437, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline to 12 Months in Lumbar Spine Bone Mineral Density (BMD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '362', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '91-day Levonorgestrel OC', 'description': 'Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).'}, {'id': 'OG001', 'title': '28-day Levonorgestrel OC', 'description': 'Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).'}, {'id': 'OG002', 'title': 'Untreated Control', 'description': 'Participants received no oral contraceptives during the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.26', 'spread': '0.168', 'groupId': 'OG000'}, {'value': '1.45', 'spread': '0.171', 'groupId': 'OG001'}, {'value': '2.50', 'spread': '0.139', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.67', 'ciUpperLimit': '0.20', 'estimateComment': 'Difference = OC group minus the untreated control', 'groupDescription': 'The primary efficacy endpoint (percent change from baseline to 12 months in lumbar spine BMD) was analyzed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': '91-day levonorgestrel OC was declared to be non-inferior to the untreated control group if the lower bound of the 2-sided 95% confidence interval (CI) was greater than -3%.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.05', 'ciLowerLimit': '-1.49', 'ciUpperLimit': '-0.61', 'estimateComment': 'Difference = OC group minus the untreated control', 'groupDescription': 'The primary efficacy endpoint (percent change from baseline to 12 months in lumbar spine BMD) was analyzed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': '28-day levonorgestrel OC was declared to be non-inferior to the untreated control group if the lower bound of the 2-sided 95% confidence interval (CI) was greater than -3%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 12', 'description': 'Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.\n\nPercent change from Baseline was calculated as (BMD at Month 12 - BMD at Baseline)/BMD at Baseline \\* 100%.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol analysis set, including all participants who received at least 1 dose of study treatment (does not apply to Control group), had both Baseline and one post-baseline assessment via DXA, and who completed all procedures at all scheduled study visits including the 12-month DXA scans, and did not have any major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Lumbar Spine Bone Mineral Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '362', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '91-day Levonorgestrel OC', 'description': 'Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).'}, {'id': 'OG001', 'title': '28-day Levonorgestrel OC', 'description': 'Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).'}, {'id': 'OG002', 'title': 'Untreated Control', 'description': 'Participants received no oral contraceptives during the study.'}], 'classes': [{'title': 'Change from Baseline to Month 6', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.001', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.001', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.001', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Month 12', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.002', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.002', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.001', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.00', 'ciUpperLimit': '0.01', 'groupDescription': 'Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '-0.00', 'groupDescription': 'Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.00', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.00', 'groupDescription': 'Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '-0.01', 'groupDescription': 'Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 6 and Month 12', 'description': 'Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.', 'unitOfMeasure': 'g/cm^2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol analysis set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Lumbar Spine Bone Mineral Content (BMC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '362', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '91-day Levonorgestrel OC', 'description': 'Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).'}, {'id': 'OG001', 'title': '28-day Levonorgestrel OC', 'description': 'Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).'}, {'id': 'OG002', 'title': 'Untreated Control', 'description': 'Participants received no oral contraceptives during the study.'}], 'classes': [{'title': 'Change from Baseline to Month 6', 'categories': [{'measurements': [{'value': '1.29', 'spread': '0.095', 'groupId': 'OG000'}, {'value': '0.69', 'spread': '0.097', 'groupId': 'OG001'}, {'value': '1.12', 'spread': '0.079', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Month 12', 'categories': [{'measurements': [{'value': '1.86', 'spread': '0.120', 'groupId': 'OG000'}, {'value': '1.20', 'spread': '0.122', 'groupId': 'OG001'}, {'value': '1.94', 'spread': '0.099', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.42', 'groupDescription': 'Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.43', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '-0.18', 'groupDescription': 'Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '0.24', 'groupDescription': 'Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.74', 'ciLowerLimit': '-1.05', 'ciUpperLimit': '-0.42', 'groupDescription': 'Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 6 and Month 12', 'description': 'Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.', 'unitOfMeasure': 'g', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol analysis set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Proximal Femur Bone Mineral Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}, {'value': '362', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '91-day Levonorgestrel OC', 'description': 'Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).'}, {'id': 'OG001', 'title': '28-day Levonorgestrel OC', 'description': 'Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).'}, {'id': 'OG002', 'title': 'Untreated Control', 'description': 'Participants received no oral contraceptives during the study.'}], 'classes': [{'title': 'Change from Baseline to Month 6 (n=238, 227, 358)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.001', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.001', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.001', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Month 12 (n=238, 224, 359)', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.002', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.002', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.001', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.01', 'groupDescription': 'Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.00', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.00', 'groupDescription': 'Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.01', 'groupDescription': 'Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '0.95', 'paramValue': '-0.00', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.00', 'groupDescription': 'Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 6 and Month 12', 'description': 'Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.', 'unitOfMeasure': 'g/cm^2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol analysis set with available Baseline proximal femur DXA scans; participants with available proximal femur DXA scans at each time point are indicated by "n".'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Proximal Femur Bone Mineral Content (BMC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}, {'value': '362', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '91-day Levonorgestrel OC', 'description': 'Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).'}, {'id': 'OG001', 'title': '28-day Levonorgestrel OC', 'description': 'Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).'}, {'id': 'OG002', 'title': 'Untreated Control', 'description': 'Participants received no oral contraceptives during the study.'}], 'classes': [{'title': 'Change from Baseline to Month 6 (n=238, 227, 358)', 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.059', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.061', 'groupId': 'OG001'}, {'value': '0.13', 'spread': '0.049', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Month 12 (n=238, 224, 359)', 'categories': [{'measurements': [{'value': '0.59', 'spread': '0.066', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '0.068', 'groupId': 'OG001'}, {'value': '0.43', 'spread': '0.055', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.28', 'groupDescription': 'Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.11', 'groupDescription': 'Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.34', 'groupDescription': 'Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.03', 'groupDescription': 'Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 6 and Month 12', 'description': 'Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.', 'unitOfMeasure': 'g', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol analysis set with available Baseline proximal femur DXA scans; participants with available proximal femur DXA scans at each time point are indicated by "n".'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Body Bone Mineral Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '91-day Levonorgestrel OC', 'description': 'Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).'}, {'id': 'OG001', 'title': '28-day Levonorgestrel OC', 'description': 'Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).'}, {'id': 'OG002', 'title': 'Untreated Control', 'description': 'Participants received no oral contraceptives during the study.'}], 'classes': [{'title': 'Change from Baseline to Month 6 (n=130, 126, 149)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.001', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.001', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.001', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Month 12 (n=130, 126, 150)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.002', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.002', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.001', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.00', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.00', 'groupDescription': 'Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.00', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.00', 'groupDescription': 'Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.00', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '-0.00', 'groupDescription': 'Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.00', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '-0.00', 'groupDescription': 'Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 6 and Month 12', 'description': 'Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.', 'unitOfMeasure': 'g/cm^2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol analysis set with Baseline total body DXA scans. Participants with available total body DXA scans at each time point are indicated by "n".'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Body Bone Mineral Content (BMC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '91-day Levonorgestrel OC', 'description': 'Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).'}, {'id': 'OG001', 'title': '28-day Levonorgestrel OC', 'description': 'Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).'}, {'id': 'OG002', 'title': 'Untreated Control', 'description': 'Participants received no oral contraceptives during the study.'}], 'classes': [{'title': 'Change from Baseline to Month 6 (n=130, 126, 149)', 'categories': [{'measurements': [{'value': '40.77', 'spread': '6.571', 'groupId': 'OG000'}, {'value': '38.70', 'spread': '6.638', 'groupId': 'OG001'}, {'value': '46.26', 'spread': '6.231', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Month 12 (n=130, 126, 150)', 'categories': [{'measurements': [{'value': '72.86', 'spread': '8.325', 'groupId': 'OG000'}, {'value': '63.78', 'spread': '8.409', 'groupId': 'OG001'}, {'value': '84.95', 'spread': '7.871', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.48', 'ciLowerLimit': '-23.57', 'ciUpperLimit': '12.61', 'groupDescription': 'Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.55', 'ciLowerLimit': '-25.65', 'ciUpperLimit': '10.55', 'groupDescription': 'Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.09', 'ciLowerLimit': '-34.99', 'ciUpperLimit': '10.81', 'groupDescription': 'Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.17', 'ciLowerLimit': '-44.08', 'ciUpperLimit': '1.74', 'groupDescription': 'Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 6 and Month 12', 'description': 'Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.', 'unitOfMeasure': 'g', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol analysis set with Baseline total body DXA scans. Participants with available total body DXA scans at each time point are indicated by "n".'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Bone-specific Alkaline Phosphatase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}, {'value': '356', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '91-day Levonorgestrel OC', 'description': 'Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).'}, {'id': 'OG001', 'title': '28-day Levonorgestrel OC', 'description': 'Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).'}, {'id': 'OG002', 'title': 'Untreated Control', 'description': 'Participants received no oral contraceptives during the study.'}], 'classes': [{'title': 'Change from Baseline to Month 6 (n=236, 224, 353)', 'categories': [{'measurements': [{'value': '-6.8', 'spread': '8.31', 'groupId': 'OG000'}, {'value': '-5.9', 'spread': '7.84', 'groupId': 'OG001'}, {'value': '-6.2', 'spread': '10.42', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Month 12 (n=235, 225, 347)', 'categories': [{'measurements': [{'value': '-6.9', 'spread': '8.64', 'groupId': 'OG000'}, {'value': '-6.6', 'spread': '8.82', 'groupId': 'OG001'}, {'value': '-10.3', 'spread': '12.49', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 and Month 12', 'unitOfMeasure': 'µg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol analysis set with Baseline data available; participants with available data at each time point are indicated by "n".'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Deoxypyridinoline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}, {'value': '350', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '91-day Levonorgestrel OC', 'description': 'Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).'}, {'id': 'OG001', 'title': '28-day Levonorgestrel OC', 'description': 'Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).'}, {'id': 'OG002', 'title': 'Untreated Control', 'description': 'Participants received no oral contraceptives during the study.'}], 'classes': [{'title': 'Change from Baseline to Month 6 (n=234, 224, 349)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.43', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.95', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '2.33', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Month 12 (n=233, 226, 348)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.21', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '2.05', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '2.28', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 and Month 12', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol analysis set with Baseline data available; participants with available data at each time point are indicated by "n".'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Osteocalcin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}, {'value': '357', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '91-day Levonorgestrel OC', 'description': 'Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).'}, {'id': 'OG001', 'title': '28-day Levonorgestrel OC', 'description': 'Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).'}, {'id': 'OG002', 'title': 'Untreated Control', 'description': 'Participants received no oral contraceptives during the study.'}], 'classes': [{'title': 'Change from Baseline to Month 6 (n=236, 224, 354)', 'categories': [{'measurements': [{'value': '-4.8', 'spread': '7.00', 'groupId': 'OG000'}, {'value': '-3.9', 'spread': '6.74', 'groupId': 'OG001'}, {'value': '-5.1', 'spread': '11.94', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Month 12 (n=235, 225, 348)', 'categories': [{'measurements': [{'value': '-4.5', 'spread': '6.69', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '7.19', 'groupId': 'OG001'}, {'value': '-7.1', 'spread': '11.74', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 and Month 12', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol analysis set with Baseline data available; participants with available data at each time point are indicated by "n".'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Procollagen 1 N-terminal Propeptide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}, {'value': '356', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '91-day Levonorgestrel OC', 'description': 'Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).'}, {'id': 'OG001', 'title': '28-day Levonorgestrel OC', 'description': 'Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).'}, {'id': 'OG002', 'title': 'Untreated Control', 'description': 'Participants received no oral contraceptives during the study.'}], 'classes': [{'title': 'Change from Baseline to Month 6 (n=237, 225, 355)', 'categories': [{'measurements': [{'value': '-49.9', 'spread': '58.55', 'groupId': 'OG000'}, {'value': '-38.7', 'spread': '51.14', 'groupId': 'OG001'}, {'value': '-57.8', 'spread': '92.58', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Month 12 (n=235, 226, 349)', 'categories': [{'measurements': [{'value': '-50.4', 'spread': '60.20', 'groupId': 'OG000'}, {'value': '-39.8', 'spread': '55.73', 'groupId': 'OG001'}, {'value': '-86.0', 'spread': '118.69', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 and Month 12', 'unitOfMeasure': 'µg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol analysis set with Baseline data available; participants with available data at each time point are indicated by "n".'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Type I Collagen N-telopeptide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}, {'value': '357', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '91-day Levonorgestrel OC', 'description': 'Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).'}, {'id': 'OG001', 'title': '28-day Levonorgestrel OC', 'description': 'Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).'}, {'id': 'OG002', 'title': 'Untreated Control', 'description': 'Participants received no oral contraceptives during the study.'}], 'classes': [{'title': 'Change from Baseline to Month 6 (n=235, 224, 356)', 'categories': [{'measurements': [{'value': '-4.8', 'spread': '9.69', 'groupId': 'OG000'}, {'value': '-3.9', 'spread': '10.68', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '13.60', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Month 12 (n=236, 225, 350)', 'categories': [{'measurements': [{'value': '-4.5', 'spread': '10.22', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '10.71', 'groupId': 'OG001'}, {'value': '-3.1', 'spread': '12.64', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 and Month 12', 'unitOfMeasure': 'nM bone collagen equivalents (BCE)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol analysis set with Baseline data available; participants with available data at each time point are indicated by "n".'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '412', 'groupId': 'OG001'}, {'value': '437', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '91-day Levonorgestrel OC', 'description': 'Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).'}, {'id': 'OG001', 'title': '28-day Levonorgestrel OC', 'description': 'Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets (containing 100 μg LNG/20 μg EE) followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).'}, {'id': 'OG002', 'title': 'Untreated Control', 'description': 'Participants received no oral contraceptives during the study.'}], 'classes': [{'title': 'Any adverse event', 'categories': [{'measurements': [{'value': '252', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '274', 'groupId': 'OG002'}]}]}, {'title': 'Severe adverse event', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Treat-related adverse event', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Other serious adverse events', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Withdrawn from study due to adverse events', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'An adverse event was any untoward medical occurrence in a clinical investigation subject participating in the clinical study, and did not necessarily need to have a causal relationship with treatment or the clinical study. The relationship of each adverse event to study treatment or procedures, and the severity and seriousness of each adverse event was judged by the investigator, as described below.\n\nA severe AE is defined as incapacitating, with inability to perform usual activities.\n\nA serious adverse event is an adverse event occurring at any dose that resulted in any of the following outcomes or actions:\n\n* fatal or life-threatening;\n* required or prolonged inpatient hospitalization;\n* resulted in persistent or significant disability/incapacity;\n* congenital anomaly or birth defect;\n* important medical event.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set includes data from all randomly assigned participants who received at least 1 dose of study treatment and from all participants enrolled in the control group who had baseline BMD measures via DXA. One participant randomly assigned to 91-day LNG received 21-day LNG instead and is included in the 21-day LNG group for safety.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '91-day Levonorgestrel OC', 'description': 'Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).'}, {'id': 'FG001', 'title': '28-day Levonorgestrel OC', 'description': 'Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).'}, {'id': 'FG002', 'title': 'Untreated Control', 'description': 'Participants received no oral contraceptives during the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '458'}, {'groupId': 'FG001', 'numSubjects': '448'}, {'groupId': 'FG002', 'numSubjects': '455'}]}, {'type': 'Received Treatment', 'achievements': [{'comment': 'Excludes 7 participants at 1 site that was closed. One participant received 28-day OC in error.', 'groupId': 'FG000', 'numSubjects': '422'}, {'comment': 'Excludes 9 participants from one site that was closed due to audit findings.', 'groupId': 'FG001', 'numSubjects': '411'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '247'}, {'groupId': 'FG001', 'numSubjects': '240'}, {'groupId': 'FG002', 'numSubjects': '372'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '211'}, {'groupId': 'FG001', 'numSubjects': '208'}, {'groupId': 'FG002', 'numSubjects': '83'}]}], 'dropWithdraws': [{'type': 'Did Not Meet Protocol Requirements', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Non Compliance with the Protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '94'}, {'groupId': 'FG002', 'numSubjects': '45'}]}, {'type': 'Miscellaneous Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}]}]}], 'recruitmentDetails': 'Healthy, postmenarcheal, adolescent females who were either willing to be randomly assigned to 1 of 2 open-label oral contraceptive (OC) treatment regimens or who were not seeking current treatment with hormonal contraceptives and agreed not to use hormonal contraception throughout the 12-month duration of the study (control group).', 'preAssignmentDetails': 'Eligible participants initiating treatment with OCs were randomly assigned to one of the two treatment groups; eligible participants not initiating treatment with hormonal contraceptives were assigned to the untreated control group.\n\nTwenty-six participants at one clinic were excluded from all analyses as the site was closed due to audit findings.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '458', 'groupId': 'BG000'}, {'value': '448', 'groupId': 'BG001'}, {'value': '455', 'groupId': 'BG002'}, {'value': '1361', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '91-day Levonorgestrel OC', 'description': 'Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).'}, {'id': 'BG001', 'title': '28-day Levonorgestrel OC', 'description': 'Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).'}, {'id': 'BG002', 'title': 'Untreated Control', 'description': 'Participants received no oral contraceptives during the study.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16.0', 'spread': '1.61', 'groupId': 'BG000'}, {'value': '15.9', 'spread': '1.71', 'groupId': 'BG001'}, {'value': '14.8', 'spread': '1.72', 'groupId': 'BG002'}, {'value': '15.6', 'spread': '1.77', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '458', 'groupId': 'BG000'}, {'value': '448', 'groupId': 'BG001'}, {'value': '455', 'groupId': 'BG002'}, {'value': '1361', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African-American', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '246', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '251', 'groupId': 'BG000'}, {'value': '265', 'groupId': 'BG001'}, {'value': '255', 'groupId': 'BG002'}, {'value': '771', 'groupId': 'BG003'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}, {'value': '292', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1361}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'dispFirstSubmitDate': '2013-04-10', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-10', 'studyFirstSubmitDate': '2009-06-18', 'dispFirstSubmitQcDate': '2013-04-10', 'resultsFirstSubmitDate': '2014-10-03', 'studyFirstSubmitQcDate': '2009-06-18', 'dispFirstPostDateStruct': {'date': '2013-04-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-10-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-03', 'studyFirstPostDateStruct': {'date': '2009-06-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline to 12 Months in Lumbar Spine Bone Mineral Density (BMD)', 'timeFrame': 'Baseline and Month 12', 'description': 'Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.\n\nPercent change from Baseline was calculated as (BMD at Month 12 - BMD at Baseline)/BMD at Baseline \\* 100%.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Lumbar Spine Bone Mineral Density', 'timeFrame': 'Baseline, Month 6 and Month 12', 'description': 'Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.'}, {'measure': 'Change From Baseline in Lumbar Spine Bone Mineral Content (BMC)', 'timeFrame': 'Baseline, Month 6 and Month 12', 'description': 'Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.'}, {'measure': 'Change From Baseline in Proximal Femur Bone Mineral Density', 'timeFrame': 'Baseline, Month 6 and Month 12', 'description': 'Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.'}, {'measure': 'Change From Baseline in Proximal Femur Bone Mineral Content (BMC)', 'timeFrame': 'Baseline, Month 6 and Month 12', 'description': 'Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.'}, {'measure': 'Change From Baseline in Total Body Bone Mineral Density', 'timeFrame': 'Baseline, Month 6 and Month 12', 'description': 'Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.'}, {'measure': 'Change From Baseline in Total Body Bone Mineral Content (BMC)', 'timeFrame': 'Baseline, Month 6 and Month 12', 'description': 'Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.'}, {'measure': 'Change From Baseline in Bone-specific Alkaline Phosphatase', 'timeFrame': 'Baseline, Month 6 and Month 12'}, {'measure': 'Change From Baseline in Serum Deoxypyridinoline', 'timeFrame': 'Baseline, Month 6 and Month 12'}, {'measure': 'Change From Baseline in Serum Osteocalcin', 'timeFrame': 'Baseline, Month 6 and Month 12'}, {'measure': 'Change From Baseline in Serum Procollagen 1 N-terminal Propeptide', 'timeFrame': 'Baseline, Month 6 and Month 12'}, {'measure': 'Change From Baseline in Serum Type I Collagen N-telopeptide', 'timeFrame': 'Baseline, Month 6 and Month 12'}, {'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': '12 months', 'description': 'An adverse event was any untoward medical occurrence in a clinical investigation subject participating in the clinical study, and did not necessarily need to have a causal relationship with treatment or the clinical study. The relationship of each adverse event to study treatment or procedures, and the severity and seriousness of each adverse event was judged by the investigator, as described below.\n\nA severe AE is defined as incapacitating, with inability to perform usual activities.\n\nA serious adverse event is an adverse event occurring at any dose that resulted in any of the following outcomes or actions:\n\n* fatal or life-threatening;\n* required or prolonged inpatient hospitalization;\n* resulted in persistent or significant disability/incapacity;\n* congenital anomaly or birth defect;\n* important medical event.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adolescents', 'Bone Mineral Density', 'Oral Contraceptive'], 'conditions': ['Bone Mineral Density']}, 'descriptionModule': {'briefSummary': 'This study is being conducted to compare the effects of a 91-day oral contraceptive (OC) to a 28-day OC regimen on bone mineral density (BMD) in adolescent females.', 'detailedDescription': 'Participants will be randomized to either a 91-day OC or a 28-day OC. Participants not seeking hormonal contraception who meet eligibility criteria will serve as a control group. Duration of the study for each study participant will be approximately 13 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy postmenarchal adolescent female 12-18 years old, non-pregnant, nonlactating\n* Regular spontaneous menstrual cycles\n* Body mass index (BMI): 18 kg/m² to \\<30 kg/m², weight \\< 200 lbs\n* Others as dictated by the Food and Drug Administration (FDA)-approved protocol\n\nExclusion Criteria:\n\n* Any contraindication to the use of oral contraceptives\n* History of previous clinically significant adverse event while taking hormonal contraceptives\n* Use of any medication which could significantly interfere with study assessments\n* Others as dictated by FDA-approved protocol'}, 'identificationModule': {'nctId': 'NCT00924560', 'briefTitle': 'A Multicenter Study to Evaluate the Effects of a 91-day Oral Contraceptive on Bone Mineral Density in Adolescent Females', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A Multicenter, Open-Label, Randomized, Controlled Study to Compare the Effects on Bone Mineral Density of DR-105 and a 28-Day Cycle Oral Contraceptive Regimen in Healthy, Postmenarchal, Adolescent Females', 'orgStudyIdInfo': {'id': 'DR-105-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '91-day Levonorgestrel Oral Contraceptive', 'description': 'Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).', 'interventionNames': ['Drug: 91-day Levonorgestrel Oral Contraceptive']}, {'type': 'ACTIVE_COMPARATOR', 'label': '28-day Levonorgestrel Oral Contraceptive', 'description': 'Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).', 'interventionNames': ['Drug: 28-day Levonorgestrel Oral Contraceptive']}, {'type': 'NO_INTERVENTION', 'label': 'Untreated Control', 'description': 'Participants received no oral contraceptives during the study.'}], 'interventions': [{'name': '91-day Levonorgestrel Oral Contraceptive', 'type': 'DRUG', 'otherNames': ['levonorgestrel/ethinyl estradiol', 'DR-105', 'Seasonique®'], 'description': 'Levonorgestrel/ethinyl estradiol 0.15/0.03 mg and ethinyl estradiol 0.01 mg tablet.\n\nTake 1 tablet daily', 'armGroupLabels': ['91-day Levonorgestrel Oral Contraceptive']}, {'name': '28-day Levonorgestrel Oral Contraceptive', 'type': 'DRUG', 'otherNames': ['levonorgestrel/ethinyl estradiol', 'Lessina®'], 'description': 'Levonorgestrel/ethinyl estradiol 0.10/0.02 mg tablet and placebo. Take 1 tablet daily', 'armGroupLabels': ['28-day Levonorgestrel Oral Contraceptive']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Teva Investigational Site 007', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Teva Investigational Site 018', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Teva Investigational Site 005', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'North Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Teva Investigational Site 047', 'geoPoint': {'lat': 34.76954, 'lon': -92.26709}}, {'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 027', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 040', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 037', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 013', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 017', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 025', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Teva Investigational Site 022', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 004', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 008', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 026', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 001', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 003', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 028', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 041', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'city': 'Champaign', 'state': 'Illinois', 'country': 'United States', 'facility': 'Teva Investigational Site 034', 'geoPoint': {'lat': 40.11642, 'lon': -88.24338}}, {'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Teva Investigational Site 023', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Teva Investigational Site 021', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Teva Investigational Site 030', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Teva Investigational Site 009', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'city': 'Lawrenceville', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Teva Investigational Site 010', 'geoPoint': {'lat': 40.29733, 'lon': -74.7296}}, {'city': 'Port Jefferson', 'state': 'New York', 'country': 'United States', 'facility': 'Teva Investigational Site 038', 'geoPoint': {'lat': 40.94649, 'lon': -73.06927}}, {'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Teva Investigational Site 048', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 002', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'city': 'Kernersville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 043', 'geoPoint': {'lat': 36.11986, 'lon': -80.07365}}, {'city': 'New Bern', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 044', 'geoPoint': {'lat': 35.10849, 'lon': -77.04411}}, {'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 020', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 006', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Teva Investigational Site 033', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Teva Investigational Site 012', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Teva Investigational Site 035', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Pottstown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Teva Investigational Site 039', 'geoPoint': {'lat': 40.24537, 'lon': -75.64963}}, {'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Teva Investigational Site 036', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 032', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 024', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 046', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 031', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 045', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Waco', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 011', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}, {'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Teva Investigational Site 015', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Teva Investigational Site 019', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Teva Investigational Site 014', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Teva Investigational Site 016', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'Jen Henrick', 'role': 'STUDY_CHAIR', 'affiliation': 'Teva GBP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duramed Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}