Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-03-17 @ 7:14 AM
Study NCT ID:
NCT07215806
Status:
COMPLETED
Last Update Posted:
2025-11-14
First Post:
2025-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Evobrutinib on Pharmacokinetics of a Combined Oral Contraceptive
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003277', 'term': 'Contraceptives, Oral, Combined'}, {'id': 'D004997', 'term': 'Ethinyl Estradiol'}, {'id': 'D009640', 'term': 'Norethindrone'}], 'ancestors': [{'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D003276', 'term': 'Contraceptives, Oral'}, {'id': 'D003271', 'term': 'Contraceptive Agents, Female'}, {'id': 'D003270', 'term': 'Contraceptive Agents'}, {'id': 'D012102', 'term': 'Reproductive Control Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'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'}, {'id': 'D009652', 'term': 'Norpregnenes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'service@emdgroup.com', 'phone': '+49-6151-72-5200', 'title': 'Communication Center', 'organization': 'Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 46 days', 'eventGroups': [{'id': 'EG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 9, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abnormal faeces', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Defaecation urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Restless legs syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Polymenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Ethinyl Estradiol and Norethisterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.'}], 'classes': [{'title': 'Ethinyl Estradiol', 'categories': [{'measurements': [{'value': '1090', 'spread': '26.7', 'groupId': 'OG000'}]}]}, {'title': 'Norethisterone', 'categories': [{'measurements': [{'value': '36000', 'spread': '35.9', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.3, 0.6, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hours post-dose on Days 1, 2, 3, 4, 15, 16, 17 and 18', 'description': 'AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Lambda z, where Clast pred was the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above the Lower Limit of quantification (LLOQ) and Lambda z was the apparent terminal rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.', 'unitOfMeasure': 'hour × picogram per milliliter (h×pg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics (PK) Analysis set included all participants who have completed the study without any relevant protocol deviations and factors likely to affect the comparability of PK results; with adequate study intervention compliance; with evaluable PK data, i.e., no missing values for primary endpoints at each PK profile/assessment day (Day 1, Day 15).'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol and Norethisterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.'}], 'classes': [{'title': 'Ethinyl Estradiol', 'categories': [{'measurements': [{'value': '51.8', 'spread': '30.1', 'groupId': 'OG000'}]}]}, {'title': 'Norethisterone', 'categories': [{'measurements': [{'value': '4620', 'spread': '34.0', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.3, 0.6, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hours post-dose on Days 1, 2, 3, 4, 15, 16, 17 and 18', 'description': 'Cmax was obtained directly from the concentration versus time curve.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics (PK) Analysis set included all participants who have completed the study without any relevant protocol deviations and factors likely to affect the comparability of PK results; with adequate study intervention compliance; with evaluable PK data, i.e., no missing values for primary endpoints at each PK profile/assessment day (Day 1, Day 15).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment- Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 46 days', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs were defined as events with onset date or worsening during the on-treatment period. TEAEs included both serious and non-serious TEAEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants, who were administered any dose of any study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment- Emergent Adverse Events (TEAEs) by Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.'}], 'classes': [{'title': 'Mild', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 46 days', 'description': 'The Investigator assessed the severity of each AE and SAE reported during the study and assign it to one of the following categories: Mild: An event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; Moderate: An event that causes sufficient discomfort and interferes with normal everyday activities; Severe: An event that prevents normal everyday activities. Do not confuse an AE that is assessed as severe with a SAE. Severe is a category used to rate the intensity of an event; both AEs and SAEs can be assessed as severe.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants, who were administered any dose of any study intervention.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hematology Parameter: Hemoglobin at Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.780', 'spread': '7.7256', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 18', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: hemoglobin.', 'unitOfMeasure': 'gram per liter (g/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants, who were administered any dose of any study intervention.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hematology Parameter: Erythrocytes at Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.29', 'spread': '0.263', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 18', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: Erythrocytes.', 'unitOfMeasure': '10^12 cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants, who were administered any dose of any study intervention.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hematology Parameters: Platelets, Leukocytes, Neutrophils, Eosinophils, Basophils, Monocytes and Lymphocytes at Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.'}], 'classes': [{'title': 'Platelets', 'categories': [{'measurements': [{'value': '-18', 'spread': '38.0', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes', 'categories': [{'measurements': [{'value': '-0.08', 'spread': '1.395', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils', 'categories': [{'measurements': [{'value': '-0.21', 'spread': '1.390', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils', 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.050', 'groupId': 'OG000'}]}]}, {'title': 'Basophils', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.017', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.110', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes', 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.338', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 18', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: Platelets, Leukocytes, Neutrophils, Eosinophils, Basophils, Monocytes and Lymphocytes.', 'unitOfMeasure': '10^9 cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants, who were administered any dose of any study intervention.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hematology Parameters: Hematocrit, Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes and Neutrophils/Leukocytes at Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.'}], 'classes': [{'title': 'Hematocrit', 'categories': [{'measurements': [{'value': '-0.029', 'spread': '0.0227', 'groupId': 'OG000'}]}]}, {'title': 'Basophils/Leukocytes', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.30', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils/Leukocytes', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.63', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes/Leukocytes', 'categories': [{'measurements': [{'value': '3.2', 'spread': '8.44', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes/Leukocytes', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.34', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils/Leukocytes', 'categories': [{'measurements': [{'value': '-3.0', 'spread': '9.30', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 18', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: Hematocrit, Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes and Neutrophils/Leukocytes.', 'unitOfMeasure': 'percentage of cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants, who were administered any dose of any study intervention.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Coagulation Parameter: Activated Partial Thromboplastin Time at Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '0.84', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 18', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the coagulation parameter: Activated Partial Thromboplastin Time.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants, who were administered any dose of any study intervention.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin at Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.06283', 'spread': '0.541316', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 18', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: Erythrocytes Mean Corpuscular Hemoglobin.', 'unitOfMeasure': 'picogram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants, who were administered any dose of any study intervention.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume at Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.95', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 18', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: Erythrocytes Mean Corpuscular Volume.', 'unitOfMeasure': 'femtoliters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants, who were administered any dose of any study intervention.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Coagulation Parameter: Prothrombin Intl. Normalized Ratio at Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.042', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 18', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the coagulation parameter: Prothrombin Intl. Normalized Ratio.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants, who were administered any dose of any study intervention.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Urate at Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.'}], 'classes': [{'title': 'Bilirubin', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '3.11', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine', 'categories': [{'measurements': [{'value': '-4', 'spread': '6.2', 'groupId': 'OG000'}]}]}, {'title': 'Urate', 'categories': [{'measurements': [{'value': '4.1', 'spread': '31.48', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 18', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameter: bilirubin, creatinine and urate.', 'unitOfMeasure': 'micromole per liter (mcmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants, who were administered any dose of any study intervention.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Chemistry Parameters: Aspartate Aminotransferase, Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Lipase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.'}], 'classes': [{'title': 'Aspartate Aminotransferase', 'categories': [{'measurements': [{'value': '-2', 'spread': '6.2', 'groupId': 'OG000'}]}]}, {'title': 'Alanine Aminotransferase', 'categories': [{'measurements': [{'value': '3', 'spread': '11.8', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline Phosphatase', 'categories': [{'measurements': [{'value': '-4', 'spread': '10.1', 'groupId': 'OG000'}]}]}, {'title': 'Amylase', 'categories': [{'measurements': [{'value': '-1', 'spread': '7.5', 'groupId': 'OG000'}]}]}, {'title': 'Lipase', 'categories': [{'measurements': [{'value': '-2.0', 'spread': '7.77', 'groupId': 'OG000'}]}]}, {'title': 'Gamma Glutamyl Transferase', 'categories': [{'measurements': [{'value': '0', 'spread': '5.4', 'groupId': 'OG000'}]}]}, {'title': 'Lactate Dehydrogenase', 'categories': [{'measurements': [{'value': '-35', 'spread': '19.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 18', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameter: Aspartate Aminotransferase, Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Lipase, Gamma Glutamyl Transferase and Lactate Dehydrogenase.', 'unitOfMeasure': 'units per liter (U/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants, who were administered any dose of any study intervention.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Chemistry Parameters: Sodium, Potassium, Calcium, Glucose, Chloride and Triglycerides at Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.'}], 'classes': [{'title': 'Sodium', 'categories': [{'measurements': [{'value': '1', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Potassium', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.397', 'groupId': 'OG000'}]}]}, {'title': 'Calcium', 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.077', 'groupId': 'OG000'}]}]}, {'title': 'Glucose', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.385', 'groupId': 'OG000'}]}]}, {'title': 'Chloride', 'categories': [{'measurements': [{'value': '2', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.29', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 18', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameter: Sodium, Potassium, Calcium, Glucose, Chloride and Triglycerides.', 'unitOfMeasure': 'millimoles per liter (mmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants, who were administered any dose of any study intervention.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Chemistry Parameters: Total Protein at Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2', 'spread': '3.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 18', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameter: Total Protein.', 'unitOfMeasure': 'gram per liter (g/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants, who were administered any dose of any study intervention.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Chemistry Parameters: C Reactive Protein at Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'spread': '8.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 18', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameter: C Reactive Protein.', 'unitOfMeasure': 'milligram per liter (g/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants, who were administered any dose of any study intervention.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure at Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.'}], 'classes': [{'title': 'Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '4', 'spread': '12.5', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '3', 'spread': '9.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 18', 'description': 'Diastolic blood pressure and systolic blood pressure were measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions.', 'unitOfMeasure': 'millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants, who were administered any dose of any study intervention.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vital Signs: Pulse Rate at Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'spread': '10.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 18', 'description': 'Pulse rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants, who were administered any dose of any study intervention.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vital Signs: Respiratory Rate at Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '1.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 18', 'description': 'Respiratory rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions.', 'unitOfMeasure': 'breaths per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants, who were administered any dose of any study intervention.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vital Signs: Temperature at Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '0.49', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 18', 'description': 'Temperature was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions.', 'unitOfMeasure': 'degree Celsius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants, who were administered any dose of any study intervention.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Electrocardiograms (ECGs) Parameter: Heart Rate at Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4', 'spread': '7.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 18', 'description': 'Heart rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants, who were administered any dose of any study intervention.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Electrocardiograms (ECGs) Parameter: RR Duration, QT Duration, QTcF Duration, PR Duration, QRS Duration at Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.'}], 'classes': [{'title': 'RR Duration', 'categories': [{'measurements': [{'value': '51', 'spread': '98.4', 'groupId': 'OG000'}]}]}, {'title': 'QT Duration', 'categories': [{'measurements': [{'value': '3', 'spread': '17.8', 'groupId': 'OG000'}]}]}, {'title': 'QTcF Duration', 'categories': [{'measurements': [{'value': '-5', 'spread': '11.0', 'groupId': 'OG000'}]}]}, {'title': 'PR Duration', 'categories': [{'measurements': [{'value': '3', 'spread': '15.3', 'groupId': 'OG000'}]}]}, {'title': 'QRS Duration', 'categories': [{'measurements': [{'value': '-2', 'spread': '9.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 18', 'description': 'RR Duration, QT Duration, QTcF Duration, PR Duration, QRS Duration was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions.', 'unitOfMeasure': 'milliseconds (msec)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants, who were administered any dose of any study intervention.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ethinyl Estradiol and Norethisterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.'}], 'classes': [{'title': 'Ethinyl Estradiol', 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '1.50', 'upperLimit': '6.02'}]}]}, {'title': 'Norethisterone', 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '0.667', 'upperLimit': '3.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 0.3, 0.6, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hours post-dose on Days 1, 2, 3, 4, 15, 16, 17 and 18', 'description': 'Time to reach the maximum observed plasma concentration (Tmax) was obtained directly from the concentration versus time curve.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics (PK) Analysis set included all participants: who have completed the study without any relevant protocol deviations and factors likely to affect the comparability of PK results; with adequate study intervention compliance; with evaluable PK data, i.e., no missing values for primary endpoints at each PK profile/assessment day (Day 1, Day 15).'}, {'type': 'SECONDARY', 'title': 'Terminal Half Life (T1/2) of Ethinyl Estradiol and Norethisterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.'}], 'classes': [{'title': 'Ethinyl Estradiol', 'categories': [{'measurements': [{'value': '21.5', 'groupId': 'OG000', 'lowerLimit': '10.5', 'upperLimit': '32.1'}]}]}, {'title': 'Norethisterone', 'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000', 'lowerLimit': '7.58', 'upperLimit': '20.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 0.3, 0.6, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hours post-dose on Days 1, 2, 3, 4, 15, 16, 17 and 18', 'description': 'Terminal half-life was calculated as log2 divided by lambda z. Lambda z was terminal elimination rate constant determined from the terminal slope of the log-transformed plasma concentration curve.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics (PK) Analysis set included all participants: who have completed the study without any relevant protocol deviations and factors likely to affect the comparability of PK results; with adequate study intervention compliance; with evaluable PK data, i.e., no missing values for primary endpoints at each PK profile/assessment day (Day 1, Day 15).'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Ethinyl Estradiol and Norethisterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.'}], 'classes': [{'title': 'Ethinyl Estradiol', 'categories': [{'measurements': [{'value': '964', 'spread': '26.9', 'groupId': 'OG000'}]}]}, {'title': 'Norethisterone', 'categories': [{'measurements': [{'value': '35100', 'spread': '36.4', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.3, 0.6, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hours post-dose on Days 1, 2, 3, 4, 15, 16, 17 and 18', 'description': 'The AUC from time zero (= dosing time) to the last sampling time (tlast) at which the concentration is at or above the lower limit of quantification (LLOQ). Calculated using the mixed log-linear trapezoidal rule (linear up, log down).', 'unitOfMeasure': 'h×pg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics (PK) Analysis set included all participants: who have completed the study without any relevant protocol deviations and factors likely to affect the comparability of PK results; with adequate study intervention compliance; with evaluable PK data, i.e., no missing values for primary endpoints at each PK profile/assessment day (Day 1, Day 15).'}, {'type': 'SECONDARY', 'title': 'Apparent Total Body Clearance (CL/f) of Ethinyl Estradiol and Norethisterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.'}], 'classes': [{'title': 'Ethinyl Estradiol', 'categories': [{'measurements': [{'value': '27.6', 'spread': '26.7', 'groupId': 'OG000'}]}]}, {'title': 'Norethisterone', 'categories': [{'measurements': [{'value': '13.9', 'spread': '35.9', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.3, 0.6, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hours post-dose on Days 1, 2, 3, 4, 15, 16, 17 and 18', 'description': 'Apparent total body clearance of drug from plasma following extravascular administration, calculated as dose/AUC0-infinity for Ethinyl Estradiol/Norethisterone.', 'unitOfMeasure': 'Liter per hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics (PK) Analysis set included all participants: who have completed the study without any relevant protocol deviations and factors likely to affect the comparability of PK results; with adequate study intervention compliance; with evaluable PK data, i.e., no missing values for primary endpoints at each PK profile/assessment day (Day 1, Day 15).'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution During Terminal Phase (VZ/f) of Ethinyl Estradiol and Norethisterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.'}], 'classes': [{'title': 'Ethinyl Estradiol', 'categories': [{'measurements': [{'value': '816', 'spread': '26.0', 'groupId': 'OG000'}]}]}, {'title': 'Norethisterone', 'categories': [{'measurements': [{'value': '252', 'spread': '46.7', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.3, 0.6, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hours post-dose on Days 1, 2, 3, 4, 15, 16, 17 and 18', 'description': 'Vz/f is defined as the apparent volume of distribution during the terminal phase following extravascular administration for Ethinyl Estradiol/Norethisterone.', 'unitOfMeasure': 'Liter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics (PK) Analysis set included all participants: who have completed the study without any relevant protocol deviations and factors likely to affect the comparability of PK results; with adequate study intervention compliance; with evaluable PK data, i.e., no missing values for primary endpoints at each PK profile/assessment day (Day 1, Day 15).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '6.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-20', 'size': 4353993, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-10-29T07:01', 'hasProtocol': True}, {'date': '2022-09-13', 'size': 1039005, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-10-29T07:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-29', 'studyFirstSubmitDate': '2025-10-08', 'resultsFirstSubmitDate': '2025-10-29', 'studyFirstSubmitQcDate': '2025-10-10', 'lastUpdatePostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-29', 'studyFirstPostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Ethinyl Estradiol and Norethisterone', 'timeFrame': 'Pre-dose, 0.3, 0.6, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hours post-dose on Days 1, 2, 3, 4, 15, 16, 17 and 18', 'description': 'AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Lambda z, where Clast pred was the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above the Lower Limit of quantification (LLOQ) and Lambda z was the apparent terminal rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol and Norethisterone', 'timeFrame': 'Pre-dose, 0.3, 0.6, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hours post-dose on Days 1, 2, 3, 4, 15, 16, 17 and 18', 'description': 'Cmax was obtained directly from the concentration versus time curve.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment- Emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to 46 days', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs were defined as events with onset date or worsening during the on-treatment period. TEAEs included both serious and non-serious TEAEs.'}, {'measure': 'Number of Participants With Treatment- Emergent Adverse Events (TEAEs) by Severity', 'timeFrame': 'Up to 46 days', 'description': 'The Investigator assessed the severity of each AE and SAE reported during the study and assign it to one of the following categories: Mild: An event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; Moderate: An event that causes sufficient discomfort and interferes with normal everyday activities; Severe: An event that prevents normal everyday activities. Do not confuse an AE that is assessed as severe with a SAE. Severe is a category used to rate the intensity of an event; both AEs and SAEs can be assessed as severe.'}, {'measure': 'Change From Baseline in Hematology Parameter: Hemoglobin at Day 18', 'timeFrame': 'Baseline, Day 18', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: hemoglobin.'}, {'measure': 'Change From Baseline in Hematology Parameter: Erythrocytes at Day 18', 'timeFrame': 'Baseline, Day 18', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: Erythrocytes.'}, {'measure': 'Change From Baseline in Hematology Parameters: Platelets, Leukocytes, Neutrophils, Eosinophils, Basophils, Monocytes and Lymphocytes at Day 18', 'timeFrame': 'Baseline, Day 18', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: Platelets, Leukocytes, Neutrophils, Eosinophils, Basophils, Monocytes and Lymphocytes.'}, {'measure': 'Change From Baseline in Hematology Parameters: Hematocrit, Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes and Neutrophils/Leukocytes at Day 18', 'timeFrame': 'Baseline, Day 18', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: Hematocrit, Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes and Neutrophils/Leukocytes.'}, {'measure': 'Change From Baseline in Coagulation Parameter: Activated Partial Thromboplastin Time at Day 18', 'timeFrame': 'Baseline, Day 18', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the coagulation parameter: Activated Partial Thromboplastin Time.'}, {'measure': 'Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin at Day 18', 'timeFrame': 'Baseline, Day 18', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: Erythrocytes Mean Corpuscular Hemoglobin.'}, {'measure': 'Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume at Day 18', 'timeFrame': 'Baseline, Day 18', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: Erythrocytes Mean Corpuscular Volume.'}, {'measure': 'Change From Baseline in Coagulation Parameter: Prothrombin Intl. Normalized Ratio at Day 18', 'timeFrame': 'Baseline, Day 18', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the coagulation parameter: Prothrombin Intl. Normalized Ratio.'}, {'measure': 'Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Urate at Day 18', 'timeFrame': 'Baseline, Day 18', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameter: bilirubin, creatinine and urate.'}, {'measure': 'Change From Baseline in Chemistry Parameters: Aspartate Aminotransferase, Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Lipase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Day 18', 'timeFrame': 'Baseline, Day 18', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameter: Aspartate Aminotransferase, Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Lipase, Gamma Glutamyl Transferase and Lactate Dehydrogenase.'}, {'measure': 'Change From Baseline in Chemistry Parameters: Sodium, Potassium, Calcium, Glucose, Chloride and Triglycerides at Day 18', 'timeFrame': 'Baseline, Day 18', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameter: Sodium, Potassium, Calcium, Glucose, Chloride and Triglycerides.'}, {'measure': 'Change From Baseline in Chemistry Parameters: Total Protein at Day 18', 'timeFrame': 'Baseline, Day 18', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameter: Total Protein.'}, {'measure': 'Change From Baseline in Chemistry Parameters: C Reactive Protein at Day 18', 'timeFrame': 'Baseline, Day 18', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameter: C Reactive Protein.'}, {'measure': 'Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure at Day 18', 'timeFrame': 'Baseline, Day 18', 'description': 'Diastolic blood pressure and systolic blood pressure were measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions.'}, {'measure': 'Change From Baseline in Vital Signs: Pulse Rate at Day 18', 'timeFrame': 'Baseline, Day 18', 'description': 'Pulse rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions.'}, {'measure': 'Change From Baseline in Vital Signs: Respiratory Rate at Day 18', 'timeFrame': 'Baseline, Day 18', 'description': 'Respiratory rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions.'}, {'measure': 'Change From Baseline in Vital Signs: Temperature at Day 18', 'timeFrame': 'Baseline, Day 18', 'description': 'Temperature was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions.'}, {'measure': 'Change From Baseline in Electrocardiograms (ECGs) Parameter: Heart Rate at Day 18', 'timeFrame': 'Baseline, Day 18', 'description': 'Heart rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions'}, {'measure': 'Change From Baseline in Electrocardiograms (ECGs) Parameter: RR Duration, QT Duration, QTcF Duration, PR Duration, QRS Duration at Day 18', 'timeFrame': 'Baseline, Day 18', 'description': 'RR Duration, QT Duration, QTcF Duration, PR Duration, QRS Duration was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions.'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ethinyl Estradiol and Norethisterone', 'timeFrame': 'Pre-dose, 0.3, 0.6, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hours post-dose on Days 1, 2, 3, 4, 15, 16, 17 and 18', 'description': 'Time to reach the maximum observed plasma concentration (Tmax) was obtained directly from the concentration versus time curve.'}, {'measure': 'Terminal Half Life (T1/2) of Ethinyl Estradiol and Norethisterone', 'timeFrame': 'Pre-dose, 0.3, 0.6, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hours post-dose on Days 1, 2, 3, 4, 15, 16, 17 and 18', 'description': 'Terminal half-life was calculated as log2 divided by lambda z. Lambda z was terminal elimination rate constant determined from the terminal slope of the log-transformed plasma concentration curve.'}, {'measure': 'Area Under the Plasma Concentration Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Ethinyl Estradiol and Norethisterone', 'timeFrame': 'Pre-dose, 0.3, 0.6, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hours post-dose on Days 1, 2, 3, 4, 15, 16, 17 and 18', 'description': 'The AUC from time zero (= dosing time) to the last sampling time (tlast) at which the concentration is at or above the lower limit of quantification (LLOQ). Calculated using the mixed log-linear trapezoidal rule (linear up, log down).'}, {'measure': 'Apparent Total Body Clearance (CL/f) of Ethinyl Estradiol and Norethisterone', 'timeFrame': 'Pre-dose, 0.3, 0.6, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hours post-dose on Days 1, 2, 3, 4, 15, 16, 17 and 18', 'description': 'Apparent total body clearance of drug from plasma following extravascular administration, calculated as dose/AUC0-infinity for Ethinyl Estradiol/Norethisterone.'}, {'measure': 'Apparent Volume of Distribution During Terminal Phase (VZ/f) of Ethinyl Estradiol and Norethisterone', 'timeFrame': 'Pre-dose, 0.3, 0.6, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hours post-dose on Days 1, 2, 3, 4, 15, 16, 17 and 18', 'description': 'Vz/f is defined as the apparent volume of distribution during the terminal phase following extravascular administration for Ethinyl Estradiol/Norethisterone.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug-drug interaction', 'Clinical pharmacology'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS200527_0079', 'label': 'Trial Awareness and Transparency website'}, {'url': 'https://www.merckgroup.com/en/company/contact-us/medinfo-contact-map.html', 'label': 'Medical Information Location Map - Med Info Contacts'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to assess the effect of M2951 on the pharmacokinetics (PK) of a combined oral contraceptive \\[Ethinyl estradiol/Norethisterone (EE/NET)\\] in healthy female participants.\n\n* Study Duration: up to 46 days\n* Treatment Duration: Days 4 to 17 (14 days treatment with M2951); Days 1 and 15 (2 days treatment with Combined Oral Contraceptive \\[COC\\])\n* Visit Frequency: Participants were resident in the Clinical Research Unit from Day -1 to Day 18.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '68 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants are overtly healthy as determined by medical evaluation, including no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion\n* Participants have a body weight within 50.0 and 100.0 kilograms (kg) (inclusive) and body mass index within the range 19.0 and 30.0 kilograms per square meter (kg/m\\^2) (inclusive)\n* Participants are nonsmokers for at least 6 months preceding Screening\n* Female participants who are not a Woman of Childbearing Potential (WOCBP)\n* Other protocol defined inclusion criteria could apply\n\nExclusion Criteria:\n\n* Participants with history or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders, as determined by medical evaluation\n* Participants with diagnosis of hemochromatosis, Wilson´s disease, alpha 1 antitrypsin deficiency, or any other chronic liver disease including Gilbert's disease will be excluded from the study\n* Participants with prior history of splenectomy or any clinically relevant surgery within 3 months prior to Screening\n* Participants with history of any malignancy\n* Participants with history of chronic or recurrent acute infection or any bacterial, viral, parasitic, or fungal infections within 30 days prior to Screening and at any time between Screening and admission, or hospitalization due to infection within 6 months prior to Screening\n* Participants with history of shingles within 12 months prior to Screening\n* Administration of live vaccines or live-attenuated virus vaccines within 3 months prior to Screening. Administration of other types of vaccines \\[e.g., Severe acute respiratory syndrome coronavirus 2 (SARSCoV2) vaccines\\] is allowed until 4 weeks before admission to CRU, thereafter it is prohibited until the end of the study\n* Note: In case of clinical symptoms, the participant should be symptom-free for at least 1 week prior to admission to Clinical Research Unit (CRU)\n* Other protocol defined exclusion criteria could apply"}, 'identificationModule': {'nctId': 'NCT07215806', 'briefTitle': 'Effect of Evobrutinib on Pharmacokinetics of a Combined Oral Contraceptive', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany'}, 'officialTitle': 'A Phase I, Open-Label, Multiple-Dose Study of the Effect of Evobrutinib on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Female Participants', 'orgStudyIdInfo': {'id': 'MS200527_0079'}, 'secondaryIdInfos': [{'id': '2022-000124-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'COC + Evobrutinib', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.', 'interventionNames': ['Drug: Evobruitnib', 'Drug: Combined oral contraceptive [ethinyl estradiol/ norethisterone (EE/NET)]']}], 'interventions': [{'name': 'Evobruitnib', 'type': 'DRUG', 'description': 'Participants received Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.', 'armGroupLabels': ['COC + Evobrutinib']}, {'name': 'Combined oral contraceptive [ethinyl estradiol/ norethisterone (EE/NET)]', 'type': 'DRUG', 'description': 'Participants received combined oral contraceptive (COC) \\[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\\], 0.5 mg of Norethisterone (NET)\\] orally on Day 1 and 15.', 'armGroupLabels': ['COC + Evobrutinib']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Neu-Ulm', 'country': 'Germany', 'facility': 'Nuvisan GmbH', 'geoPoint': {'lat': 48.39279, 'lon': 10.01112}}], 'overallOfficials': [{'name': 'Medical Responsible', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website http://bit.ly/IPD21'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}