Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT01019369
Status:
COMPLETED
Last Update Posted:
2019-05-07
First Post:
2009-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Self or Clinic Administration of DepoProvera
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017258', 'term': 'Medroxyprogesterone Acetate'}], 'ancestors': [{'id': 'D008525', 'term': 'Medroxyprogesterone'}, {'id': 'D006908', 'term': 'Hydroxyprogesterones'}, {'id': 'D011374', 'term': 'Progesterone'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anitra.beasley@bcm.edu', 'phone': '832-826-7318', 'title': 'Anitra Beasley, MD, MPH', 'organization': 'Baylor College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Self Administration of DMPA', 'description': 'Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)\n\nMedroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year', 'otherNumAtRisk': 86, 'otherNumAffected': 0, 'seriousNumAtRisk': 86, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Clinic Administration of DMPA', 'description': 'Clinic administration (routine care) of DMPA\n\nMedroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year', 'otherNumAtRisk': 46, 'otherNumAffected': 0, 'seriousNumAtRisk': 46, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Continuing DMPA at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self Administration of DMPA', 'description': 'Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)\n\nMedroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year'}, {'id': 'OG001', 'title': 'Clinic Administration of DMPA', 'description': 'Clinic administration (routine care) of DMPA\n\nMedroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'The study was designed to examine if increasing accessibility to DMPA by decreasing the need for multiple clinic visits will increase participant continuation of DMPA', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was analyzed with the assumption that participants who were "lost to follow-up" had discontinued DMPA use.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Continuing DMPA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self Administration of DMPA', 'description': 'Self administration of subcutaneous depot medroxyprogesterone acetate\n\nMedroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year'}, {'id': 'OG001', 'title': 'Clinic Administration of DMPA', 'description': 'Clinic administration (routine care) of DMPA\n\nMedroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3, 9, 12 months', 'description': 'The study was designed to examine the increasing accessibility to DMPA by decreasing the need for multiple clinic visits will increase method continuation rates at all other endpoints.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '115 women w 12 month follow-up data (76 and 39) . 10 participants LTFU in self-administration group, and 7 participants LTFU in the clinic administration group.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Would Continue With Self Administration of SC DMPA if it Were Available', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self Administration of DMPA', 'description': 'Self administration of subcutaneous depot medroxyprogesterone acetate\n\nMedroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year'}, {'id': 'OG001', 'title': 'Clinic Administration of DMPA', 'description': 'Clinic administration (routine care) of DMPA\n\nMedroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year'}], 'timeFrame': '6, 12 months', 'description': 'The study was designed to examine if self administration of SC DMPA is an acceptable alternative to clinic administration of SC DMPA', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected. No analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Prevalence of Participants With Persistent Skin Changes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self Administration of DMPA', 'description': 'Self administration of subcutaneous depot medroxyprogesterone acetate\n\nMedroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year'}, {'id': 'OG001', 'title': 'Clinic Administration of DMPA', 'description': 'Clinic administration (routine care) of DMPA\n\nMedroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year'}], 'timeFrame': '12 months', 'description': 'The study was designed to examine if using SC DMPA will cause skin changes (dimpling, induration, or atrophy)', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected. No analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Scaled Satisfaction Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self Administration of DMPA', 'description': 'Self administration of subcutaneous depot medroxyprogesterone acetate\n\nMedroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year'}, {'id': 'OG001', 'title': 'Clinic Administration of DMPA', 'description': 'Clinic administration (routine care) of DMPA\n\nMedroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year'}], 'timeFrame': '6, 12 months', 'description': 'This study was designed to examine if age, parity, partner support, and personal motivation to avoid pregnancy will predict method continuation rates with questionnaires.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected. No analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Average Minutes Spent Getting Ready for and Giving the Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self Administration of DMPA', 'description': 'Self administration of subcutaneous depot medroxyprogesterone acetate\n\nMedroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year'}, {'id': 'OG001', 'title': 'Clinic Administration of DMPA', 'description': 'Clinic administration (routine care) of DMPA\n\nMedroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year'}], 'timeFrame': '0-12 months', 'description': 'In total, how much time did the participant spend getting ready for and giving the injection. This includes the time the participant spent getting ready to come to the clinic, getting to the appointment, and waiting for the provider for the control group.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected. No analysis was performed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Self Administration of DMPA', 'description': 'Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)\n\nMedroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year'}, {'id': 'FG001', 'title': 'Clinic Administration of DMPA', 'description': 'Clinic administration (routine care) of DMPA\n\nMedroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Self Administration of DMPA', 'description': 'Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)\n\nMedroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year'}, {'id': 'BG001', 'title': 'Clinic Administration of DMPA', 'description': 'Clinic administration (routine care) of DMPA\n\nMedroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26', 'spread': '6.1', 'groupId': 'BG000'}, {'value': '26.1', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '26.03', 'spread': '6.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '132', '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': '86', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-16', 'studyFirstSubmitDate': '2009-11-18', 'resultsFirstSubmitDate': '2014-12-04', 'studyFirstSubmitQcDate': '2009-11-24', 'lastUpdatePostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-04-14', 'studyFirstPostDateStruct': {'date': '2009-11-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Continuing DMPA at 6 Months', 'timeFrame': '6 months', 'description': 'The study was designed to examine if increasing accessibility to DMPA by decreasing the need for multiple clinic visits will increase participant continuation of DMPA'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Continuing DMPA', 'timeFrame': '3, 9, 12 months', 'description': 'The study was designed to examine the increasing accessibility to DMPA by decreasing the need for multiple clinic visits will increase method continuation rates at all other endpoints.'}, {'measure': 'Number of Participants Who Would Continue With Self Administration of SC DMPA if it Were Available', 'timeFrame': '6, 12 months', 'description': 'The study was designed to examine if self administration of SC DMPA is an acceptable alternative to clinic administration of SC DMPA'}, {'measure': 'Prevalence of Participants With Persistent Skin Changes', 'timeFrame': '12 months', 'description': 'The study was designed to examine if using SC DMPA will cause skin changes (dimpling, induration, or atrophy)'}, {'measure': 'Scaled Satisfaction Score', 'timeFrame': '6, 12 months', 'description': 'This study was designed to examine if age, parity, partner support, and personal motivation to avoid pregnancy will predict method continuation rates with questionnaires.'}, {'measure': 'Average Minutes Spent Getting Ready for and Giving the Injection', 'timeFrame': '0-12 months', 'description': 'In total, how much time did the participant spend getting ready for and giving the injection. This includes the time the participant spent getting ready to come to the clinic, getting to the appointment, and waiting for the provider for the control group.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contraception', 'Medroxyprogesterone 17-acetate', 'Self administration'], 'conditions': ['Contraception']}, 'referencesModule': {'references': [{'pmid': '24656555', 'type': 'DERIVED', 'citation': 'Beasley A, White KO, Cremers S, Westhoff C. Randomized clinical trial of self versus clinical administration of subcutaneous depot medroxyprogesterone acetate. Contraception. 2014 May;89(5):352-6. doi: 10.1016/j.contraception.2014.01.026. Epub 2014 Feb 7.'}]}, 'descriptionModule': {'briefSummary': 'Depot medroxyprogesterone acetate (DepoProvera) is an acceptable form of contraception for many women. However, difficulty in access may cause many women to discontinue use, often without the use of another effective method of contraception, thereby leaving them vulnerable to unintended pregnancy. This study will randomly assign women who present for contraceptive services to two groups: self or clinic administered SC DMPA. The participants will be followed for one year to compare continuation rates, acceptability, cost effectiveness, evidence of skin changes, and need for continued support between the two groups.', 'detailedDescription': 'Unintended pregnancy remains a worldwide problem in both developed and developing countries. In 2001, 49% of pregnancies in the United States were unintended. Moreover, more than 6 million women annually are at high risk of becoming unintentionally pregnant because of a gap in contraceptive use, and disadvantaged women are more likely to have more difficulty than others with continuous method use. Multiple strategies have been explored and implemented to increase the effective usage of contraception, including promoting the use of longer acting reversible contraceptives.\n\nDifficulty in access to depot medroxyprogesterone acetate (DMPA) remains a problem. With the advent of a subcutaneous formulation of DMPA, administration outside of the clinical setting is possible. The acceptability of self administered DMPA has also been reviewed, with favorable outcomes; however, the actual intervention has not been studied.\n\nThis study will recruit women presenting for abortion or contraceptive services at the Columbia University and New York Presbyterian affiliated Family Planning Clinic and Special Gynecology Services who desire DMPA for contraception. Women will be randomized to two groups: self administration of SC DMPA or clinic administration of SC DMPA. The primary objective of this study is to compare the continuation rates of SC DMPA between the self and clinic administration groups at 6 months. Secondary outcomes include participant satisfaction, cost effectiveness of self-injected use of DMPA, baseline predictors of method continuation or discontinuation, evidence of persistent skin changes following administration of SC DMPA, and need for continued clinical support.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age greater than or equal to 18 years\n2. seeking DMPA for contraception\n3. English or Spanish speaking\n4. consistent access to a working telephone\n5. availability for follow up for one year\n\nExclusion Criteria:\n\n1. suspected or continuing pregnancy\n2. undiagnosed vaginal bleeding\n3. known or suspected breast cancer\n4. acute liver disease\n5. known hypersensitivity to medroxyprogesterone acetate or any other components of DMPA\n6. desire for pregnancy within one year'}, 'identificationModule': {'nctId': 'NCT01019369', 'briefTitle': 'Study of Self or Clinic Administration of DepoProvera', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Randomized Clinical Trial of Self Versus Clinical Administration of Depot Medroxyprogesterone Acetate', 'orgStudyIdInfo': {'id': 'AAAD8306'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self Administration of DMPA', 'description': 'Self administration of subcutaneous depot medroxyprogesterone acetate', 'interventionNames': ['Drug: Medroxyprogesterone 17-Acetate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clinic administration of DMPA', 'description': 'Clinic administration (routine care) of DMPA', 'interventionNames': ['Drug: Medroxyprogesterone 17-Acetate']}], 'interventions': [{'name': 'Medroxyprogesterone 17-Acetate', 'type': 'DRUG', 'otherNames': ['depo-subQ 104'], 'description': 'Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year', 'armGroupLabels': ['Self Administration of DMPA']}, {'name': 'Medroxyprogesterone 17-Acetate', 'type': 'DRUG', 'otherNames': ['depo-subQ 104'], 'description': 'Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year', 'armGroupLabels': ['Clinic administration of DMPA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University/New York Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Carolyn Westhoff, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}, {'name': 'Anitra Beasley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carolyn L. Westhoff', 'class': 'OTHER'}, 'collaborators': [{'name': 'Family Planning Fellowship', 'class': 'OTHER'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Obstetrics and Gynecology, Population and Family Health and Epidemiology', 'investigatorFullName': 'Carolyn L. Westhoff', 'investigatorAffiliation': 'Columbia University'}}}}