Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-04 @ 5:52 AM
Study NCT ID:
NCT02689804
Status:
COMPLETED
Last Update Posted:
2017-07-07
First Post:
2016-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
EC PK in Women With Normal and Obese BMI
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016912', 'term': 'Levonorgestrel'}, {'id': 'D003281', 'term': 'Contraceptives, Postcoital'}, {'id': 'C555622', 'term': 'ulipristal acetate'}], 'ancestors': [{'id': 'D009644', 'term': 'Norgestrel'}, {'id': 'D009652', 'term': 'Norpregnenes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clw3@columbia.edu', 'phone': '212-305-4805', 'title': 'Carolyn L. Westhoff, MD', 'organization': 'Columbia University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'description': 'The Total Number of Participants at Risk is not consistent with numbers provided in the rows in the Participant Flow module. There were 16 participants classified as "Normal-BMI" and 16 participants classified as "Obese-BMI", and all participants received all interventions; however, PRS instructed for the investigator to further split the 2 BMI arms into the time period when "Normal" and "Obese-BMI" received each drug, so that the reported events can be attributed to the appropriate drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Normal-BMI on LNG', 'description': 'Women with normal BMI will receive LNG-EC', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 4, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Normal-BMI on UPA', 'description': 'Women with obese BMI will receive UPA-EC', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 3, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Obese-BMI on LNG', 'description': 'Women with obese BMI will receive LNG-EC', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 4, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Obese-BMI on UPA', 'description': 'Women with obese BMI will receive UPA-EC', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lower abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Curve From Time 0 to 24 Hours of Serum LNG Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal-BMI', 'description': 'Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.'}, {'id': 'OG001', 'title': 'Obese-BMI', 'description': 'Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.'}], 'classes': [{'categories': [{'measurements': [{'value': '208.5', 'groupId': 'OG000', 'lowerLimit': '171.4', 'upperLimit': '245.6'}, {'value': '100.8', 'groupId': 'OG001', 'lowerLimit': '82.9', 'upperLimit': '118.7'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 hours', 'description': 'LNG-EC PK parameter (AUC 0-24 h) in women with normal and obese BMI women.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cross-over study: 16 normal-BMI and 16 obese-BMI enrolled and each participant received both drugs in random order.'}, {'type': 'PRIMARY', 'title': 'Area Under the Curve From Time 0 to 24 Hours of Serum UPA Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal-BMI', 'description': 'Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.'}, {'id': 'OG001', 'title': 'Obese-BMI', 'description': 'Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.'}], 'classes': [{'categories': [{'measurements': [{'value': '293.5', 'groupId': 'OG000', 'lowerLimit': '237.3', 'upperLimit': '349.8'}, {'value': '362.5', 'groupId': 'OG001', 'lowerLimit': '230.9', 'upperLimit': '494.1'}]}]}], 'analyses': [{'pValue': '0.15', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 hours', 'description': 'UPA-EC PK parameter (AUC 0-24 h) in women with normal and obese BMI women.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cross-over study: 16 normal-BMI and 16 obese-BMI enrolled and each participant received both drugs in random order.'}, {'type': 'SECONDARY', 'title': 'Elimination Half-life of Serum LNG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal-BMI', 'description': 'Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.'}, {'id': 'OG001', 'title': 'Obese-BMI', 'description': 'Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.0', 'groupId': 'OG000', 'lowerLimit': '22.2', 'upperLimit': '31.8'}, {'value': '50.4', 'groupId': 'OG001', 'lowerLimit': '44.6', 'upperLimit': '56.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 hours', 'description': '(t1/2) calculated in women with normal and obese BMI', 'unitOfMeasure': 'h', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cross-over study: 16 normal-BMI and 16 obese-BMI enrolled and each participant received both drugs in random order.'}, {'type': 'SECONDARY', 'title': 'Elimination Half-life of Serum UPA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal-BMI', 'description': 'Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.'}, {'id': 'OG001', 'title': 'Obese-MRI', 'description': 'Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.9', 'groupId': 'OG000', 'lowerLimit': '24.0', 'upperLimit': '45.8'}, {'value': '65.9', 'groupId': 'OG001', 'lowerLimit': '50.8', 'upperLimit': '81.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 hours', 'description': '(t1/2) calculated in women with normal and obese BMI', 'unitOfMeasure': 'h', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Cross-over study: 16 normal-BMI and 16 obese-BMI enrolled and each participant received both drugs in random order.'}, {'type': 'SECONDARY', 'title': 'Clearance of Serum LNG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal-BMI', 'description': 'Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.'}, {'id': 'OG001', 'title': 'Obese-MRI', 'description': 'Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '5.8'}, {'value': '9.8', 'groupId': 'OG001', 'lowerLimit': '8.3', 'upperLimit': '11.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 hours', 'description': '(Cl) calculated in women with normal and obese BMI', 'unitOfMeasure': 'L/h', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clearance of Serum UPA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal-BMI', 'description': 'Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.'}, {'id': 'OG001', 'title': 'Obese-MRI', 'description': 'Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '5.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '4.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 hours', 'description': '(Cl) calculated in women with normal and obese BMI', 'unitOfMeasure': 'L/h', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maximum Concentration of Serum LNG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal-BMI', 'description': 'Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.'}, {'id': 'OG001', 'title': 'Obese-MRI', 'description': 'Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000', 'lowerLimit': '14.0', 'upperLimit': '22.4'}, {'value': '10.8', 'groupId': 'OG001', 'lowerLimit': '6.8', 'upperLimit': '14.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 hours', 'description': '(Cmax) calculated in women with normal and obese BMI', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maximum Concentration of Serum UPA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal-BMI', 'description': 'Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.'}, {'id': 'OG001', 'title': 'Obese-MRI', 'description': 'Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.3', 'groupId': 'OG000', 'lowerLimit': '57.4', 'upperLimit': '121.2'}, {'value': '95.6', 'groupId': 'OG001', 'lowerLimit': '65.8', 'upperLimit': '125.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 hours', 'description': '(Cmax) calculated in women with normal and obese BMI', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Concentration of Serum LNG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal-BMI', 'description': 'Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.'}, {'id': 'OG001', 'title': 'Obese-MRI', 'description': 'Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 hours', 'description': '(Tmax) calculated in women with normal and obese BMI', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Concentration of Serum UPA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal-BMI', 'description': 'Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.'}, {'id': 'OG001', 'title': 'Obese-MRI', 'description': 'Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs LNG-EC and UPA-EC will be given in random order.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 hours', 'description': '(Tmax) calculated in women with normal and obese BMI', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Normal-BMI', 'description': 'Women with normal BMI will receive the first emergency contraception (EC) dose and complete pharmacokinetics (PK) assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs Levonorgestrel (LNG-EC) and Ulipristal Acetate (UPA-EC) will be given in random order.'}, {'id': 'FG001', 'title': 'Obese-MRI', 'description': 'Women with obese BMI will receive the first emergency contraception (EC) dose and complete pharmacokinetics (PK) assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs Levonorgestrel (LNG-EC) and Ulipristal Acetate (UPA-EC) will be given in random order.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'No significant events in the study that occur after participant enrollment, but prior to assignment of participants to an arm or group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Normal-BMI', 'description': 'Women with normal BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs (LNG-EC and UPA-EC will be given in random order).'}, {'id': 'BG001', 'title': 'Obese-BMI', 'description': 'Women with obese BMI will receive the first EC dose and complete PK assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs (LNG-EC and UPA-EC will be given in random order).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.8', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '35'}, {'value': '32.3', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '45'}, {'value': '30', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '45'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This is a cross-over study with the same 32 participants receiving each study drug. 34 participants were enrolled into this study but 2 participants discontinued. The final sample includes a total of 16 normal-BMI women and 16 obese-BMI women.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-30', 'studyFirstSubmitDate': '2016-02-16', 'resultsFirstSubmitDate': '2017-02-14', 'studyFirstSubmitQcDate': '2016-02-23', 'lastUpdatePostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-30', 'studyFirstPostDateStruct': {'date': '2016-02-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve From Time 0 to 24 Hours of Serum LNG Concentration', 'timeFrame': 'Up to 24 hours', 'description': 'LNG-EC PK parameter (AUC 0-24 h) in women with normal and obese BMI women.'}, {'measure': 'Area Under the Curve From Time 0 to 24 Hours of Serum UPA Concentration', 'timeFrame': 'Up to 24 hours', 'description': 'UPA-EC PK parameter (AUC 0-24 h) in women with normal and obese BMI women.'}], 'secondaryOutcomes': [{'measure': 'Elimination Half-life of Serum LNG', 'timeFrame': 'Up to 24 hours', 'description': '(t1/2) calculated in women with normal and obese BMI'}, {'measure': 'Elimination Half-life of Serum UPA', 'timeFrame': 'Up to 24 hours', 'description': '(t1/2) calculated in women with normal and obese BMI'}, {'measure': 'Clearance of Serum LNG', 'timeFrame': 'Up to 24 hours', 'description': '(Cl) calculated in women with normal and obese BMI'}, {'measure': 'Clearance of Serum UPA', 'timeFrame': 'Up to 24 hours', 'description': '(Cl) calculated in women with normal and obese BMI'}, {'measure': 'Maximum Concentration of Serum LNG', 'timeFrame': 'Up to 24 hours', 'description': '(Cmax) calculated in women with normal and obese BMI'}, {'measure': 'Maximum Concentration of Serum UPA', 'timeFrame': 'Up to 24 hours', 'description': '(Cmax) calculated in women with normal and obese BMI'}, {'measure': 'Time to Maximum Concentration of Serum LNG', 'timeFrame': 'Up to 24 hours', 'description': '(Tmax) calculated in women with normal and obese BMI'}, {'measure': 'Time to Maximum Concentration of Serum UPA', 'timeFrame': 'Up to 24 hours', 'description': '(Tmax) calculated in women with normal and obese BMI'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Emergency contraception'], 'conditions': ['Contraception']}, 'referencesModule': {'availIpds': [{'url': 'http://dx.doi.org/10.1016/j.contraception.2017.01.004', 'type': 'Publication', 'comment': 'Results Reference: Yes'}], 'references': [{'pmid': '21920190', 'type': 'BACKGROUND', 'citation': 'Glasier A, Cameron ST, Blithe D, Scherrer B, Mathe H, Levy D, Gainer E, Ulmann A. Can we identify women at risk of pregnancy despite using emergency contraception? Data from randomized trials of ulipristal acetate and levonorgestrel. Contraception. 2011 Oct;84(4):363-7. doi: 10.1016/j.contraception.2011.02.009. Epub 2011 Apr 2.'}, {'pmid': '25528415', 'type': 'BACKGROUND', 'citation': 'Kapp N, Abitbol JL, Mathe H, Scherrer B, Guillard H, Gainer E, Ulmann A. Effect of body weight and BMI on the efficacy of levonorgestrel emergency contraception. Contraception. 2015 Feb;91(2):97-104. doi: 10.1016/j.contraception.2014.11.001. Epub 2014 Nov 8.'}, {'pmid': '26368848', 'type': 'BACKGROUND', 'citation': 'Gemzell-Danielsson K, Kardos L, von Hertzen H. Impact of bodyweight/body mass index on the effectiveness of emergency contraception with levonorgestrel: a pooled-analysis of three randomized controlled trials. Curr Med Res Opin. 2015 Dec;31(12):2241-8. doi: 10.1185/03007995.2015.1094455. Epub 2015 Oct 27.'}]}, 'descriptionModule': {'briefSummary': 'A well-designed pharmacokinetics (PK) study may identify the physiologic basis for observed differences in levonorgestrel emergency contraception (LNG-EC) and ulipristal acetate emergency contraception (UPA-EC) failure rates in women with normal and obese BMI. The investigators propose a study to compare serum LNG and UPA levels after administration of a single-dose of LNG-EC or UPA-EC. The investigators hypothesize that there will be no difference in PK parameters between women with normal BMI and obese women.', 'detailedDescription': "Eligible women will present to the division research office, at which time a history and physical exam will be completed. Each participant's BMI will be confirmed and she will be assigned to one of two BMI groups (18.5-24.9 versus 30-39.9). At the conclusion of the enrollment visit, the research coordinator will randomize each woman to receive a single-dose pill of either levonorgestrel 1.5mg (like Plan B One-Step® or its generic formulations) or ulipristal acetate 30mg (ellaOne®) on two separate occasions."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women aged 18-45 years\n* English-speaking\n* BMI 18.5-24.9 kg/m2 or obese BMI 30.0-39.9 kg/m2\n* Regular menstrual cycles\n* No use of medroxyprogesterone acetate at least 6 months prior to study enrollment, unless resumption of two menstrual cycles\n* No use of levonorgestrel intrauterine system (levonorgestrel-IUS), etonogestrel implant or combined hormonal contraception at least one month prior to the study and resumption of one menstrual cycle\n* Women who are postpartum or post-abortion will be included if they have had at least one menstrual cycle since their last pregnancy\n\nExclusion Criteria:\n\n* Prior allergic reaction to LNG-EC or UPA-EC\n* Use of hormonal emergency contraception within the past month\n* Women who are currently pregnant or who are currently breastfeeding\n* History of cancer other than non-melanoma skin cancer\n* Medical or surgical conditions or conditions requiring therapies known to impact sex steroid production or metabolism\n\n * Use of HAART therapy for management of HIV infection\n * Concomitant use of CYP3A4 inducers like rifampin, barbiturates, carbamazepine, lamotrigine, bosentan, felbamate, griseofulvin, oxcarbazepine, phenytoin, St. John's Wort and topiramate\n* Current participation in any other trial of an investigational medicine or device in the three months leading up to this study"}, 'identificationModule': {'nctId': 'NCT02689804', 'briefTitle': 'EC PK in Women With Normal and Obese BMI', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Pharmacokinetics of Levonorgestrel and Ulipristal Acetate Emergency Contraception in Women With Normal and Obese Body Mass Index', 'orgStudyIdInfo': {'id': 'AAAP1857'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Normal-BMI', 'description': 'Women with normal BMI will receive the first emergency contraception (EC) dose and complete pharmacokinetics (PK) assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs Levonorgestrel (LNG-EC) and Ulipristal Acetate (UPA-EC) will be given in random order.', 'interventionNames': ['Drug: LNG-EC', 'Drug: UPA-EC']}, {'type': 'OTHER', 'label': 'Obese-BMI', 'description': 'Women with obese BMI will receive the first emergency contraception (EC) dose and complete pharmacokinetics (PK) assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs Levonorgestrel (LNG-EC) and Ulipristal Acetate (UPA-EC) will be given in random order.', 'interventionNames': ['Drug: LNG-EC', 'Drug: UPA-EC']}], 'interventions': [{'name': 'LNG-EC', 'type': 'DRUG', 'otherNames': ['Levonorgestrel (LNG) emergency contraceptive (EC)', 'Next Choice One Dose'], 'description': 'FDA-approved emergency contraceptive pill containing levonorgestrel 1.5mg', 'armGroupLabels': ['Normal-BMI', 'Obese-BMI']}, {'name': 'UPA-EC', 'type': 'DRUG', 'otherNames': ['Ulipristal acetate (UPA) emergency contraceptive (EC)', 'ella'], 'description': 'FDA-approved emergency contraceptive pill containing ulipristal acetate 30mg', 'armGroupLabels': ['Normal-BMI', 'Obese-BMI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Carolyn L Westhoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director, Division of Family Planning and Preventive Services'}, {'name': 'Piyapa Praditpan, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Clinical instructor, Division of Family Planning and Preventive Services'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Division of Family Planning and Preventive Services', 'investigatorFullName': 'Carolyn L. Westhoff', 'investigatorAffiliation': 'Columbia University'}}}}