Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT01592058
Status:
COMPLETED
Last Update Posted:
2012-07-31
First Post:
2012-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Weight Change Among Users of Three Progestin-Only Methods of Contraception Over a 12-Month Time Period
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D015430', 'term': 'Weight Gain'}], 'ancestors': [{'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 427}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-30', 'studyFirstSubmitDate': '2012-05-02', 'studyFirstSubmitQcDate': '2012-05-02', 'lastUpdatePostDateStruct': {'date': '2012-07-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'Baseline and 12 months', 'description': 'Change in weight from baseline at 12 months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['weight change', 'contraception', 'birth control', 'progestin', 'progestin only', 'weight gain', 'depo', 'Depo Provera', 'DMPA', 'IUD', 'IUC', 'Mirena', 'Paragard', 'Implanon', 'implant'], 'conditions': ['Weight Change']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.choiceproject.wustl.edu/', 'label': 'The Contraceptive CHOICE Project website - parent study for BMI'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to learn whether women who use progestin-only methods of birth control such as the contraceptive implant (Implanon), the levonorgestral-releasing IUS (Mirena), or depot medroxyprogesterone acetate(DMPA) will experience weight change compared to women using the non-hormonal copper IUC (ParaGard).\n\nThe investigators primary hypothesis is that users of DMPA will gain excess weight and increase their BMI above the copper-IUC users; secondarily, the investigators will compare users' data in the LNG-IUC and ENG implant groups to the copper-IUC group."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants already enrolled in the Contraceptive CHOICE Project will be offered participation during their 12-month follow up window if they had originally selected one of the four methods being studied during CHOICE enrollment.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients enrolled in CHOICE between the ages of 18 and 45 who consented to future studies\n* Chose levonorgestrel-releasing IUD, copper IUD, the implant, or DMPA as their CHOICE baseline method\n* Has baseline height and weight data collected from the on-campus enrollment site\n* Able to come back to the on-campus enrollment site for consent process and enrollment activities\n\nExclusion Criteria:\n\n* Recent history of DMPA use before starting their baseline CHOICE method\n* Used current method for less than 11 months or more than 12 months and three weeks'}, 'identificationModule': {'nctId': 'NCT01592058', 'acronym': 'BMI', 'briefTitle': 'Weight Change Among Users of Three Progestin-Only Methods of Contraception Over a 12-Month Time Period', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Weight Change Among Users of Three Progestin-Only Methods of Contraception Over a 12-Month Time Period', 'orgStudyIdInfo': {'id': '201102211'}}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Tessa E Madden, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}