Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-02-24 @ 8:25 AM
Study NCT ID:
NCT01930994
Status:
WITHDRAWN
Last Update Posted:
2013-10-14
First Post:
2013-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kenya Sino-implant (II) PK Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Insufficient numbers of Sino-implant users available for study participation.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-10-11', 'studyFirstSubmitDate': '2013-08-21', 'studyFirstSubmitQcDate': '2013-08-26', 'lastUpdatePostDateStruct': {'date': '2013-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total and Free LNG concentrations in Jadelle users at Four Years and Sino-implant users at Five Years', 'timeFrame': '6 months', 'description': 'Total and free LNG plasma concentrations measured at four years of Sino-implant (II)use and at five years of Jadelle use'}], 'secondaryOutcomes': [{'measure': 'Total and Free LNG concentrations at Four Years of Jadelle and Sino-implant Use', 'timeFrame': '6 months', 'description': 'Total and free LNG plasma concentrations at 4 years of Sino-implant (II) use and total and free LNG plasma concentrations at 4 years of Jadelle use'}, {'measure': 'Total and free LNG plasma concentration-time profiles at 4 years following Sino-implant (II) and at over 5 years following Jadelle insertion', 'timeFrame': '6 months', 'description': 'Total and free LNG plasma concentration-time profiles at 4 years of Sino-implant(II)use compared to over 5 years of Jadelle use'}, {'measure': 'SHBG serum concentration-time profile over 4 years following Sino-implant (II) and over 5 years following Jadelle insertion.', 'timeFrame': '6 months', 'description': 'SHBG serum concentration-time profile at at 4 years of Sino-implant(II)use compared to over 5 years of Jadelle use'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['LNG: Levonorgestrel', 'MSI: Marie Stopes International', 'MSK: Marie Stopes Kenya', 'PK: Pharmacokinetic'], 'conditions': ['Contraception']}, 'descriptionModule': {'briefSummary': 'A cross-sectional study to compare pharmacokinetics of Sino-implant (II) during four years of used and Jadelle during five years of use by Kenyan women.', 'detailedDescription': 'A cross-sectional study to compare the pharmacokinetics of Sino-implant (II) during four years of use and Jadelle during five years of use by Kenyan women. The active ingredient in both implants is levonorgestrel (LNG) which is a synthetic progestin that has been used in combined oral contraceptives and in progestin-only pills for more than 30 years.\n\nPopulation: A total of 280 women between the ages of 18 to 44 years who are currently using Sino-implant (II) or Jadelle contraceptive implants will be enrolled in one of six cohorts of women:\n\nCohort 1: (n=20 Sino-implant (II), n=20 Jadelle) women enrolled 1-3 months before their 6-month insertion anniversary.\n\nCohort 2: (n=20 Sino-implant (II), n=20 Jadelle) women enrolled 1-3 months before their 12-month insertion anniversary.\n\nCohort 3: (n=20 Sino-implant (II), n=20 Jadelle) women enrolled 1-3 months before their 24-month insertion anniversary.\n\nCohort 4: (n=20 Sino-implant (II), n=20 Jadelle) women enrolled 1-3 months before their 36-month insertion anniversary.\n\nCohort 5: (n=40 Sino-implant (II), n=40 Jadelle) women enrolled 1-3 months before their 48-month insertion anniversary.\n\nCohort 6: (n=40 Jadelle) women enrolled 2-6 months before their 60-month insertion anniversary.\n\nWomen in all cohorts will be followed for up to 6 months.\n\nStudy Duration: Up to 6 months of participant recruitment and up to 6 months elapsed after the baseline visit for the second study visits. 15 months total in the field including training, study initiation, recruitment, follow-up, and close-out.\n\nTwo blood samples spaced 2 to 6 months apart will be drawn from each woman for hormone measurements.\n\nPrimary Objective: To compare total and free levonorgestrel (LNG) plasma concentrations at four years of Sino-implant (II) use to total and free LNG plasma concentrations at five years of Jadelle use in Kenyan women\n\nSecondary Objectives:\n\n1. To compare total and free LNG plasma concentrations at four years of Sino-implant (II) use to total and free LNG plasma concentrations at four years of Jadelle use\n2. To characterize the total and free LNG plasma concentration-time profiles over four years following Sino-implant (II) and over five years following Jadelle insertion\n3. To characterize the sex hormone binding globulin (SHBG) serum concentration-time profile over four years following Sino-implant (II) and over five years following Jadelle insertion'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women between the ages of 18 and 44 who have received contraceptive implants from the Marie Stopes Kenya Eastleigh clinic and MSK mobile clinics in the Nairobi area.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have a Sino-implant (II) or Jadelle implant set in place, confirmed by physical exam;\n* Have a confirmed contraceptive implant insertion date consistent with the criteria for the cohort she is to be enrolled in;\n* Be aged between 18 and 44 years, inclusive;\n* Not wish to become pregnant in the next six months;\n* Not desire implant removal within the next six months.\n* Be able to understand the information given to them and to make personal decisions on whether to participate or not in the study;\n* Consent to participation, and sign an informed consent form;\n* Agree and be able to return to the clinic for the second study visit.\n\nExclusion Criteria: The following criteria exclude participation in the study:\n\n* Use of rifampicin, and/or anticonvulsants (barbiturates, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, primidone, topiramate), and/or herbal products containing St. John's wort (Hypericum perforatum), by self-report;7\n* Use of medications containing LNG or other hormones that impact LNG or SHBG disposition, e.g. treatment with LNG or oral contraceptives for bleeding disturbances, by self-report;\n* Use of anti-retroviral drugs, by self-report;\n* Any condition (social or medical) which in the opinion of the Investigator would make study participation unsafe, would interfere with adherence to study requirements or complicate data interpretation."}, 'identificationModule': {'nctId': 'NCT01930994', 'briefTitle': 'Kenya Sino-implant (II) PK Study', 'organization': {'class': 'OTHER', 'fullName': 'FHI 360'}, 'officialTitle': 'A Pharmacokinetic Study to Compare Sino-implant (II) During Four Years of Use to Jadelle During Five Years of Use by Kenyan Women', 'orgStudyIdInfo': {'id': '475139'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Twenty Sino-implant (II) and twenty Jadelle users enrolled 1-3 months before their 6-month insertion anniversary.'}, {'label': 'Cohort 2', 'description': 'TwentySino-implant (II) and twenty Jadelle users enrolled 1-3 months before their 12-month insertion anniversary;'}, {'label': 'Cohort 3', 'description': 'Twenty Sino-implant (II) and twenty Jadelle) users enrolled 1-3 months before their 24-month insertion anniversary'}, {'label': 'Cohort 4', 'description': 'Twenty Sino-implant(II) and twenty Jadelle users enrolled 1-3 months before their 36-month insertion anniversary;'}, {'label': 'Cohort 5', 'description': 'Forty Sino-implant (II) and forty Jadelle users enrolled 1-3 months before their 48-month insertion anniversary;'}, {'label': 'Cohort 6', 'description': 'Forty Jadelle users enrolled 2-6 months before their 60-month insertion anniversary.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nairobi', 'country': 'Kenya', 'facility': 'Marie Stopes Kenya Eastleigh Clinic', 'geoPoint': {'lat': -1.28333, 'lon': 36.81667}}], 'overallOfficials': [{'name': 'Mark Ayallo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Marie Stopes Kenya'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FHI 360', 'class': 'OTHER'}, 'collaborators': [{'name': 'Marie Stopes International', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}