Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-03-01 @ 3:22 PM
Study NCT ID:
NCT01656434
Status:
TERMINATED
Last Update Posted:
2024-06-20
First Post:
2012-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Contraceptive Efficacy and Safety of a NOMAC-E2 Combined Oral Contraceptive (COC)(P06448)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'D004997', 'term': 'Ethinyl Estradiol'}, {'id': 'C031621', 'term': 'ferrous fumarate'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The investigator agrees to provide to the Sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication (including slides and texts of oral or other public presentations that report any results of the trial). The Sponsor has the right to review and comment on publications, abstracts, slides, and manuscripts, as well as the data analysis and presentation.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 54 weeks', 'description': 'All Subjects as Treated Population, which consisted of all randomized participants who took at least one dose of trial medication. One treated participant in the NOMAC-E2 treatment group had incomplete data and was not included in the Safety Analyses.', 'eventGroups': [{'id': 'EG000', 'title': 'NOMAC-E2', 'description': 'Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.', 'otherNumAtRisk': 2465, 'otherNumAffected': 0, 'seriousNumAtRisk': 2465, 'seriousNumAffected': 20}, {'id': 'EG001', 'title': 'NETA-EE', 'description': 'Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.', 'otherNumAtRisk': 604, 'otherNumAffected': 0, 'seriousNumAtRisk': 604, 'seriousNumAffected': 8}], 'seriousEvents': [{'term': 'Internal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bacterial pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Breast cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pelvic inflammatory disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Tubo-ovarian abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Traumatic haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Traumatic liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Epiphysiolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ovarian fibroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abortion spontaneous complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Foetal death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Substance abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2465, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of In-Treatment Pregnancies Per 100 Woman Years of Exposure (Pearl Index)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NOMAC-E2', 'description': 'Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.'}, {'id': 'OG001', 'title': 'NETA-EE', 'description': 'Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.'}], 'timeFrame': 'Up to 1 year (13 cycles)', 'description': 'Primary Efficacy Outcome measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure.', 'reportingStatus': 'POSTED', 'populationDescription': 'Planned analysis for this primary endpoint was not performed due to early study termination.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an Occurrence of Breakthrough Bleeding/Spotting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NOMAC-E2', 'description': 'Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.'}, {'id': 'OG001', 'title': 'NETA-EE', 'description': 'Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.'}], 'timeFrame': 'Up to 1 year (13 cycles)', 'description': 'Participants kept e-diaries to record their vaginal bleeding events. They were asked to record, on a daily basis, whether they experienced vaginal bleeding, which included BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. (This is also known as "breakthough" bleeding.) Vaginal bleeding that required \\>=1 pad/tampon per day was classified as BLEEDING. Vaginal bleeding that did not require a pad/tampon per day was classified as SPOTTING.', 'reportingStatus': 'POSTED', 'populationDescription': 'Planned analysis for this secondary endpoint was not performed due to early study termination.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an Absence of Withdrawal Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NOMAC-E2', 'description': 'Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.'}, {'id': 'OG001', 'title': 'NETA-EE', 'description': 'Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.'}], 'timeFrame': 'Up to 1 year (13 cycles)', 'description': 'Participants kept e-diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether vaginal bleeding was present. Absence of withdrawal bleeding was defined as no bleeding/spotting during the expected bleeding period.', 'reportingStatus': 'POSTED', 'populationDescription': 'Planned analysis for this secondary endpoint was not performed due to early study termination.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced At Least One Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2465', 'groupId': 'OG000'}, {'value': '604', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NOMAC-E2', 'description': 'Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.'}, {'id': 'OG001', 'title': 'NETA-EE', 'description': 'Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.2', 'groupId': 'OG000'}, {'value': '45.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 54 weeks', 'description': 'An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects as Treated Population, which consisted of all randomized participants who took at least one dose of trial medication. One treated participant in the NOMAC-E2 treatment group had incomplete data and was not included in the Safety Analyses.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experience at Least One Venous or Arterial Thrombotic/Thromboembolic Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2465', 'groupId': 'OG000'}, {'value': '604', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NOMAC-E2', 'description': 'Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.'}, {'id': 'OG001', 'title': 'NETA-EE', 'description': 'Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 54 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects as Treated Population, which consisted of all randomized participants who took at least one dose of trial medication. One treated participant in the NOMAC-E2 treatment group had incomplete data and was not included in the Safety Analyses.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2231', 'groupId': 'OG000'}, {'value': '549', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NOMAC-E2', 'description': 'Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.'}, {'id': 'OG001', 'title': 'NETA-EE', 'description': 'Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.'}], 'classes': [{'title': 'After Cycle 3 (n=2135; n=527)', 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '0.24', 'groupId': 'OG001'}]}]}, {'title': 'After Cycle 6 (n=1809; n=459)', 'categories': [{'measurements': [{'value': '0.64', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '0.28', 'groupId': 'OG001'}]}]}, {'title': 'After Cycle 9 (n=1468; n=391)', 'categories': [{'measurements': [{'value': '1.21', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '0.35', 'groupId': 'OG001'}]}]}, {'title': 'After Cycle 13 (n=462; n=145)', 'categories': [{'measurements': [{'value': '1.57', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '0.90', 'spread': '0.46', 'groupId': 'OG001'}]}]}, {'title': 'Last In-Treatment Measurement (n=2231; n=549)', 'categories': [{'measurements': [{'value': '1.39', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.75', 'spread': '0.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 52', 'description': "Participants' body weights were measured in a consistent manner throughout the trial, using standardized equirpment. Last In-Treatment Measurement refers to a participant's end of trial visit, the timing of which differed among participants.", 'unitOfMeasure': 'kilograms', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from All Subjects as Treated Population (all randomized participants who took at least one dose of trial medication) who had data available for Change from Baseline in Body Weight endpoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NOMAC-E2', 'description': 'Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.'}, {'id': 'FG001', 'title': 'NETA-EE', 'description': 'Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2553'}, {'groupId': 'FG001', 'numSubjects': '620'}]}, {'type': 'Treated', 'achievements': [{'comment': 'One treated participant had incomplete data and was not included in the Safety Analyses.', 'groupId': 'FG000', 'numSubjects': '2466'}, {'groupId': 'FG001', 'numSubjects': '604'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2401'}, {'groupId': 'FG001', 'numSubjects': '580'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '199'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'Enrollment terminated at trial site', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '309'}, {'groupId': 'FG001', 'numSubjects': '76'}]}, {'type': 'Site discontinued study participation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Screen failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Pregnancy wish', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1501'}, {'groupId': 'FG001', 'numSubjects': '348'}]}, {'type': 'Participant discontinued; drug related', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Part. discontinued; unrelated to drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Non-compliance with protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Participant moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Participant withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2466', 'groupId': 'BG000'}, {'value': '604', 'groupId': 'BG001'}, {'value': '3070', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'NOMAC-E2', 'description': 'Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.'}, {'id': 'BG001', 'title': 'NETA-EE', 'description': 'Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.2', 'spread': '7.6', 'groupId': 'BG000'}, {'value': '29.5', 'spread': '7.7', 'groupId': 'BG001'}, {'value': '29.3', 'spread': '7.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2466', 'groupId': 'BG000'}, {'value': '604', 'groupId': 'BG001'}, {'value': '3070', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All Subjects as Treated Population, which consisted of all randomized participants who took at least one dose of trial medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3173}}, 'statusModule': {'whyStopped': 'Business reasons', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2014-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-05', 'studyFirstSubmitDate': '2012-07-31', 'resultsFirstSubmitDate': '2015-02-09', 'studyFirstSubmitQcDate': '2012-08-02', 'lastUpdatePostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-03-12', 'studyFirstPostDateStruct': {'date': '2012-08-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of In-Treatment Pregnancies Per 100 Woman Years of Exposure (Pearl Index)', 'timeFrame': 'Up to 1 year (13 cycles)', 'description': 'Primary Efficacy Outcome measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With an Occurrence of Breakthrough Bleeding/Spotting', 'timeFrame': 'Up to 1 year (13 cycles)', 'description': 'Participants kept e-diaries to record their vaginal bleeding events. They were asked to record, on a daily basis, whether they experienced vaginal bleeding, which included BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. (This is also known as "breakthough" bleeding.) Vaginal bleeding that required \\>=1 pad/tampon per day was classified as BLEEDING. Vaginal bleeding that did not require a pad/tampon per day was classified as SPOTTING.'}, {'measure': 'Percentage of Participants With an Absence of Withdrawal Bleeding', 'timeFrame': 'Up to 1 year (13 cycles)', 'description': 'Participants kept e-diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether vaginal bleeding was present. Absence of withdrawal bleeding was defined as no bleeding/spotting during the expected bleeding period.'}, {'measure': 'Percentage of Participants Who Experienced At Least One Adverse Event', 'timeFrame': 'Up to 54 weeks', 'description': 'An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.'}, {'measure': 'Number of Participants Who Experience at Least One Venous or Arterial Thrombotic/Thromboembolic Event', 'timeFrame': 'Up to 54 weeks'}, {'measure': 'Change From Baseline in Body Weight', 'timeFrame': 'Baseline and Week 52', 'description': "Participants' body weights were measured in a consistent manner throughout the trial, using standardized equirpment. Last In-Treatment Measurement refers to a participant's end of trial visit, the timing of which differed among participants."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Combined Oral Contraceptives'], 'conditions': ['Contraception']}, 'referencesModule': {'references': [{'pmid': '31069056', 'type': 'DERIVED', 'citation': 'Rolla E. Endometriosis: advances and controversies in classification, pathogenesis, diagnosis, and treatment. F1000Res. 2019 Apr 23;8:F1000 Faculty Rev-529. doi: 10.12688/f1000research.14817.1. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to assess the contraceptive efficacy of a nomegestrol acetate + 17ß-estradiol (NOMAC-E2) combined oral contraceptive (COC) in healthy, sexually-active American women at risk for pregnancy. Vaginal bleeding patterns of women taking NOMAC-E2 were assessed and compared to those of women taking a norethisterone acetate + ethinyl estradiol (NETA-EE) COC. The safety of NOMAC-E2 was also assessed.\n\nParticipants were randomized to receive either NOMAC-E2 or NETA-EE in a 3:1 ratio. As of Amendment 1 (which increased the sample size of the NOMAC-E2 group), the randomization ratio was adapted accordingly for participants randomized after the sample size increase.', 'detailedDescription': 'This study was terminated early. The decision to terminate the study was based upon difficulties encountered with data collection (related to incomplete e-Diary entries) in concert with business considerations. The decision was not related to any new or unexpected safety or efficacy findings with NOMAC-E2. As a result of this early termination, none of the pre-specified efficacy endpoints were analyzed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Sexually active woman, at risk for pregnancy and in need of contraception\n* Not planning to use other contraceptive methods (including barrier methods \\[e.g., condoms\\]) than the study drug, during the study\n* Willing to use a COC for 12 months (13 cycles)\n* Body mass index (BMI) of ≥18 and \\<38 kg/m\\^2\n* Good physical and mental health\n* Willing to complete an electronic diary on a daily basis for the duration of the study\n\nExclusion Criteria:\n\n* Current smoker and age of \\>35 years\n* Presence or history of either venous thromboembolic diseases (deep vein thrombosis \\[DVT\\], pulmonary embolism) or arterial thromboembolic diseases (myocardial infarction, stroke)\n* History of migraine with focal neurological symptoms\n* Diabetes mellitus with vascular involvement\n* Less than two weeks of full remobilization from prolonged immobilization, major surgery, any surgery to the legs, or major trauma\n* Severe hypertension\n* Severe abnormal lipoproteins in the blood\n* Pancreatic dysfunction\n* Presence of history of severe liver disease or liver tumors\n* Known or suspected sex steroid-influenced malignancies (e.g., of the genital organs or the breasts)\n* Undiagnosed vaginal bleeding\n* Known or suspected pregnancy\n* Current or history of abuse of alcohol or drugs (e.g., laxatives)\n* Abnormal cervical smear at screening\n* Prior to start of treatment, spontaneous menstruation has not occurred following a delivery or abortion\n* Breastfeeding or has been breastfeeding within 2 months prior to start of treatment\n* Use of any investigational drugs and/or participation in any other clinical trial within 2 months prior to start of treatment\n* Use of any of the following medications prior to or during the study may prohibit inclusion: sex hormones (other than pre- and post-treatment non-injectable contraceptives), injectable hormonal contraception, phenytoin, barbiturates, primidone, bosentan, carbamazepine, topiramate, felbamate, rifampicin, ritonavir, nevirapine, efavirenz, griseofulvin, herbal remedies containing Hypericum perforatum (e.g., St. John's wort)"}, 'identificationModule': {'nctId': 'NCT01656434', 'briefTitle': 'Study of the Contraceptive Efficacy and Safety of a NOMAC-E2 Combined Oral Contraceptive (COC)(P06448)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Phase III, Randomized, Open-label, Active-controlled, Multicenter Trial to Study the Contraceptive Efficacy and Safety of the Commercial Batch of Oral Tablets of MK-8175A (Nomegestrol Acetate - 17ß-estradiol) in Healthy, Sexually-active Women Aged 18-50 Years', 'orgStudyIdInfo': {'id': 'P06448'}, 'secondaryIdInfos': [{'id': 'MK-8175A-022', 'type': 'OTHER', 'domain': 'Merck Protocol Number'}, {'id': 'SCH 900121 P06448', 'type': 'OTHER', 'domain': 'Merck Protocol ID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NOMAC-E2', 'description': 'Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.', 'interventionNames': ['Drug: NOMAC-E2', 'Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NETA-EE', 'description': 'Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.', 'interventionNames': ['Drug: NETA-EE', 'Drug: ethinylestradiol (EE)', 'Drug: ferrous fumarate']}], 'interventions': [{'name': 'NOMAC-E2', 'type': 'DRUG', 'otherNames': ['MK-8175A', 'SCH 900121', 'Org 10486-0 (NOMAC)', 'Org 2317 (E2)'], 'description': 'NOMAC-E2 film-coated oral tablets containing 2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol.', 'armGroupLabels': ['NOMAC-E2']}, {'name': 'NETA-EE', 'type': 'DRUG', 'otherNames': ['Lo Loestrin® Fe'], 'description': 'NETA-EE film-coated oral tablets containing 1 mg norethisterone acetate and 10 μg ethinylestradiol.', 'armGroupLabels': ['NETA-EE']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'tablet', 'armGroupLabels': ['NOMAC-E2']}, {'name': 'ethinylestradiol (EE)', 'type': 'DRUG', 'description': 'EE 10 μg tablet', 'armGroupLabels': ['NETA-EE']}, {'name': 'ferrous fumarate', 'type': 'DRUG', 'description': 'ferrous fumarate 75 mg tablet', 'armGroupLabels': ['NETA-EE']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}