Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-02-26 @ 6:28 AM
Study NCT ID:
NCT02408692
Status:
COMPLETED
Last Update Posted:
2017-10-25
First Post:
2015-03-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Emergency Contraception and Body Weight: Pilot Study
Sponsor:
Organization:
Raw JSON
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After this visit, women with a BMI of \\<25 kg/m2 will have completed study participation.', 'otherNumAtRisk': 5, 'otherNumAffected': 1, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Obese BMI ECx1', 'description': '5 obese women (BMI \\>30 kg/m2) taking 1.5mg LNG\n\nECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of \\<25 kg/m2 will have completed study participation.', 'otherNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Obese BMI ECx2', 'description': '5 obese women (BMI \\>30 kg/m2) taking 3mg LNG\n\nECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)', 'otherNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Emesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Serum Concentration Between Normal and Obese BMI Women Ingesting 1.5mg Levonorgestrel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal BMI ECx1', 'description': '5 normal weight women (BMI\\<25 kg/m2) taking 1.5mg LNG\n\nECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of \\<25 kg/m2 will have completed study participation.'}, {'id': 'OG001', 'title': 'Obese BMI ECx1', 'description': '5 obese women (BMI \\>30 kg/m2) taking 1.5mg LNG\n\nECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of \\<25 kg/m2 will have completed study participation.'}, {'id': 'OG002', 'title': 'Obese BMI ECx2', 'description': '5 obese women (BMI \\>30 kg/m2) taking 3mg LNG\n\nECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)'}], 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'spread': '2.47', 'groupId': 'OG000'}, {'value': '5.57', 'spread': '2.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Follicular phase of menstrual cycle and PK sampling at 0, 0.5, 1, 1.5, 2, 2.5', 'description': 'Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 1.5mg of levonorgestrel', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maximum Serum Concentration Between Obese BMI Women Ingesting 1.5mg of Levonorgestrel and Then the Same Obese BMI Women Ingesting 3mg Levonorgestrel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal BMI ECx1', 'description': '5 normal weight women (BMI\\<25 kg/m2) taking 1.5mg LNG\n\nECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of \\<25 kg/m2 will have completed study participation.'}, {'id': 'OG001', 'title': 'Obese BMI ECx1', 'description': '5 obese women (BMI \\>30 kg/m2) taking 1.5mg LNG\n\nECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of \\<25 kg/m2 will have completed study participation.'}, {'id': 'OG002', 'title': 'Obese BMI ECx2', 'description': '5 obese women (BMI \\>30 kg/m2) taking 3mg LNG\n\nECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)'}], 'classes': [{'categories': [{'measurements': [{'value': '5.57', 'spread': '2.48', 'groupId': 'OG001'}, {'value': '10.52', 'spread': '2.76', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Follicular phase of menstrual cycle', 'description': 'Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 3mg of levonorgestrel', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Normal BMI ECx1', 'description': '5 normal weight women (BMI\\<25 kg/m2) taking 1.5mg LNG\n\nECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of \\<25 kg/m2 will have completed study participation.'}, {'id': 'FG001', 'title': 'Obese BMI ECx1', 'description': '5 obese women (BMI \\>30 kg/m2) taking 1.5mg LNG\n\nECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of \\<25 kg/m2 will have completed study participation.'}, {'id': 'FG002', 'title': 'Obese BMI ECx2', 'description': '5 obese women (BMI \\>30 kg/m2) taking 3mg LNG\n\nECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Normal BMI ECx1', 'description': '5 normal weight women (BMI\\<25 kg/m2) taking 1.5mg LNG\n\nECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of \\<25 kg/m2 will have completed study participation.'}, {'id': 'BG001', 'title': 'Obese BMI ECx1', 'description': '5 obese women (BMI \\>30 kg/m2) taking 1.5mg LNG\n\nECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of \\<25 kg/m2 will have completed study participation.'}, {'id': 'BG002', 'title': 'Obese BMI ECx2', 'description': '5 obese women (BMI \\>30 kg/m2) taking 3mg LNG\n\nECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-22', 'studyFirstSubmitDate': '2015-03-27', 'resultsFirstSubmitDate': '2017-04-29', 'studyFirstSubmitQcDate': '2015-04-02', 'lastUpdatePostDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-29', 'studyFirstPostDateStruct': {'date': '2015-04-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Serum Concentration Between Normal and Obese BMI Women Ingesting 1.5mg Levonorgestrel', 'timeFrame': 'Follicular phase of menstrual cycle and PK sampling at 0, 0.5, 1, 1.5, 2, 2.5', 'description': 'Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 1.5mg of levonorgestrel'}], 'secondaryOutcomes': [{'measure': 'Maximum Serum Concentration Between Obese BMI Women Ingesting 1.5mg of Levonorgestrel and Then the Same Obese BMI Women Ingesting 3mg Levonorgestrel', 'timeFrame': 'Follicular phase of menstrual cycle', 'description': 'Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 3mg of levonorgestrel'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Emergency contraception', 'Obese BMI', 'Normal BMI'], 'conditions': ['Contraception', 'Body Weight']}, 'referencesModule': {'references': [{'pmid': '27000996', 'type': 'RESULT', 'citation': 'Edelman AB, Cherala G, Blue SW, Erikson DW, Jensen JT. Impact of obesity on the pharmacokinetics of levonorgestrel-based emergency contraception: single and double dosing. Contraception. 2016 Jul;94(1):52-7. doi: 10.1016/j.contraception.2016.03.006. Epub 2016 Mar 18.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to determine how body weight changes the drug level of an emergency contraceptive pill containing a hormone called levonorgestrel (LNG). This emergency contraceptive is available to women without a prescription, but has recently been found to not work as well to prevent pregnancies in women of higher body weight. The overall goal of this research is to improve the effectiveness of contraception for women, no matter their weight.', 'detailedDescription': 'To determine if differences exist in the pharmacokinetics (PK) of levonorgestrel-based emergency contraception (LNG-EC) in obese and normal body mass index (BMI) users and test whether doubling the dose of LNG-EC in obese women increases total and free LNG serum concentrations.\n\nWe enrolled healthy, reproductive-age women with obese and normal BMIs received 1.5 mg LNG orally and then in a subsequent menstrual cycle, the obese group also received 3 mg LNG. Total and free LNG PK parameters were obtained via serum samples through an indwelling catheter at 0, 0.5, 1, 1.5, 2, and 2.5 h. The primary outcome was the difference in total and free LNG concentration maximum (Cmax) between ECx1 and ECx2 in the obese group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects are between the ages of 18 and 35\n* Subjects are in good general health\n* Subjects have regular menstrual cycles (between 21 and 35 days)\n* Subjects are willing to use condoms (if you are sexually active with a male partner), subjects are willing to not have sex with men during the study, or subjects have had a tubal ligation (or have a partner who has had a vasectomy) or subjects have a copper intrauterine device (IUD).\n\nExclusion Criteria:\n\n* Metabolic disorders including uncontrolled thyroid dysfunction and Polycystic Ovarian Syndrome\n* Impaired liver or renal function\n* Actively seeking or involved in a weight loss program (must be weight stable)\n* Pregnancy, breastfeeding, or seeking pregnancy; recent (8 week) use of hormonal contraception\n* Current use of drugs that interfere with metabolism of sex steroids\n* Smokers.'}, 'identificationModule': {'nctId': 'NCT02408692', 'briefTitle': 'Emergency Contraception and Body Weight: Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Emergency Contraception and Body Weight: Pilot Study', 'orgStudyIdInfo': {'id': 'OHSU IRB 11419'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Normal BMI ECx1', 'description': '5 normal weight women (BMI\\<25 kg/m2) taking 1.5mg LNG', 'interventionNames': ['Drug: ECx1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Obese BMI ECx1', 'description': '5 obese women (BMI \\>30 kg/m2) taking 1.5mg LNG', 'interventionNames': ['Drug: ECx1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Obese BMI ECx2', 'description': '5 obese women (BMI \\>30 kg/m2) taking 3mg LNG', 'interventionNames': ['Drug: ECx2']}], 'interventions': [{'name': 'ECx1', 'type': 'DRUG', 'otherNames': ['Next choice', 'Emergency Contraception'], 'description': 'At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of \\<25 kg/m2 will have completed study participation.', 'armGroupLabels': ['Normal BMI ECx1', 'Obese BMI ECx1']}, {'name': 'ECx2', 'type': 'DRUG', 'otherNames': ['Next choice', 'Emergency Contraception'], 'description': 'At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)', 'armGroupLabels': ['Obese BMI ECx2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Alison Edelman, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'PI acknowledges willingness to share data and materials with other investigators through established means. Data will be presented via presentation and publication. Transfer of resources is subject to the acceptance of a Materials Transfer Agreement as required by policy at OHSU. OHSU complies with NIH policy on Sharing Research Data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical Research Foundation, Oregon', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Alison Edelman', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}