Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-28 @ 11:09 PM
Study NCT ID:
NCT02104557
Status:
COMPLETED
Last Update Posted:
2021-06-10
First Post:
2014-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post Marketing Surveillance Study For Sayana®
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to a maximum of 12 months', 'description': 'Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.', 'eventGroups': [{'id': 'EG000', 'title': 'Sayana', 'description': 'Participants were administered with Sayana (medroxyprogesterone acetate) as part of routine practice in Korean health care centers by accredited physicians per the local product document.', 'otherNumAtRisk': 337, 'deathsNumAtRisk': 337, 'otherNumAffected': 80, 'seriousNumAtRisk': 337, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART, Version 092'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART, Version 092'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART, Version 092'}, {'term': 'Weight increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART, Version 092'}, {'term': 'Skeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART, Version 092'}, {'term': 'Amenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 13}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART, Version 092'}, {'term': 'Breast pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART, Version 092'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART, Version 092'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 58}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART, Version 092'}, {'term': 'Common cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART, Version 092'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART, Version 092'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART, Version 092'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART, Version 092'}], 'seriousEvents': [{'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART, Version 092'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sayana', 'description': 'Participants were administered with Sayana (medroxyprogesterone acetate) as part of routine practice in Korean health care centers by accredited physicians per the local product document.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to a maximum of 12 months', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. AEs included both serious and all non-serious adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of Sayana.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Discontinued From Study Due to AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sayana', 'description': 'Participants were administered with Sayana (medroxyprogesterone acetate) as part of routine practice in Korean health care centers by accredited physicians per the local product document.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to a maximum of 12 months', 'description': 'Participants who discontinued permanently from the study due to AEs are reported. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of Sayana.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Used Concomitant Medications for Treating AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sayana', 'description': 'Participants were administered with Sayana (medroxyprogesterone acetate) as part of routine practice in Korean health care centers by accredited physicians per the local product document.'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to a maximum of 12 months', 'description': 'Number of participants taking any medications other than Sayana (concomitant medication) to treat AEs are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of Sayana.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Laboratory Test Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sayana', 'description': 'Participants were administered with Sayana (medroxyprogesterone acetate) as part of routine practice in Korean health care centers by accredited physicians per the local product document.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to a maximum of 12 months', 'description': "Laboratory tests included hematology, biochemistry, and urinalysis. Clinical significance was identified by investigators' judgements based on laboratory test results.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of Sayana.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Became Pregnant Over Observation Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sayana', 'description': 'Participants were administered with Sayana (medroxyprogesterone acetate) as part of routine practice in Korean health care centers by accredited physicians per the local product document.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 12 months', 'description': 'The cumulative percent of participants who became pregnant over observation period was calculated as 100\\*(1- Kaplan-Meier curve at month 12), where the Kaplan-Meier (KM) method for estimating survival function was applied to time-to-pregnancy.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis set included all participants who received at least 1 dose of Sayana and evaluated for efficacy at least once. Here, "Overall number of participants analyzed" = participants who were administered with Sayana for pregnancy prevention.'}, {'type': 'PRIMARY', 'title': 'Rate of Pregnancies Per 100 Participant-years of Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sayana', 'description': 'Participants were administered with Sayana (medroxyprogesterone acetate) as part of routine practice in Korean health care centers by accredited physicians per the local product document.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 12 months', 'description': 'Pregnancies per 100 person-years of follow-up defined as major events, incidence rate was calculated as: 100\\*(total number of participants with effectiveness endpoint)/(total person-years of participants included in the effectiveness analysis set) where total person-years is equal to (last evaluation date of outcome - first date of administration +1)/365.25 for all participants in the effective analysis set.', 'unitOfMeasure': 'pregnancies per 100 participant-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis set included all participants who received at least 1 dose of Sayana and evaluated for efficacy at least once. Here, "Overall number of participants analyzed" = participants who were administered with Sayana for pregnancy prevention.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of First Dose (Month 3) of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sayana', 'description': 'Participants were administered with Sayana (medroxyprogesterone acetate) as part of routine practice in Korean health care centers by accredited physicians per the local product document.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '48.32', 'spread': '31.9', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 3', 'categories': [{'measurements': [{'value': '-29.63', 'spread': '29.31', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3', 'description': 'Participants were asked to indicate the subjective level of endometriosis pain looking back at the last 3 months and mark it with a single vertical mark on the 100 millimeter (mm) horizontal visual analogue scale, where 0 mm represented absence of pain and 100 mm indicated unbearable pain. Higher score indicated more pain. Change from baseline in pain VAS score after administration of first dose of study drug is reported in this outcome measure.', 'unitOfMeasure': 'millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis set included all participants who received at least 1 dose of Sayana and evaluated for efficacy at least once. Here, "Overall number of participants analyzed" = participants who were administered with Sayana for the management of endometriosis-associated pain at Month 3.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Second Dose (Month 6) of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sayana', 'description': 'Participants were administered with Sayana (medroxyprogesterone acetate) as part of routine practice in Korean health care centers by accredited physicians per the local product document.'}], 'classes': [{'categories': [{'measurements': [{'value': '-33.02', 'spread': '30.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Participants were asked to indicate the subjective level of endometriosis pain looking back at the last 3 months and mark it with a single vertical mark on the 100 mm horizontal visual analogue scale, where 0 mm represented absence of pain and 100 mm indicated unbearable pain. Higher score indicated more pain. Change from baseline in pain VAS score after administration of second dose of study drug is reported in this outcome measure.', 'unitOfMeasure': 'millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis set included all participants who received at least 1 dose of Sayana and evaluated for efficacy at least once. Here, "Overall number of participants analyzed" = participants who were administered with Sayana for the management of endometriosis-associated pain at Month 6.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Third Dose (Month 9) of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sayana', 'description': 'Participants were administered with Sayana (medroxyprogesterone acetate) as part of routine practice in Korean health care centers by accredited physicians per the local product document.'}], 'classes': [{'categories': [{'measurements': [{'value': '-37.8', 'spread': '30.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 9', 'description': 'Participants were asked to indicate the subjective level of endometriosis pain looking back at the last 3 months and mark it with a single vertical mark on the 100 mm horizontal visual analogue scale, where 0 mm represented absence of pain and 100 mm indicated unbearable pain. Higher score indicated more pain. Change from baseline in pain VAS score after administration of third dose of study drug is reported in this outcome measure.', 'unitOfMeasure': 'millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis set included all participants who received at least 1 dose of Sayana and evaluated for efficacy at least once. Here, "Overall number of participants analyzed" =participants who were administered with Sayana for the management of endometriosis-associated pain at Month 9.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Fourth Dose (Month 12) of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sayana', 'description': 'Participants were administered with Sayana (medroxyprogesterone acetate) as part of routine practice in Korean health care centers by accredited physicians per the local product document.'}], 'classes': [{'categories': [{'measurements': [{'value': '-49.25', 'spread': '29.98', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'Participants were asked to indicate the subjective level of endometriosis pain looking back at the last 3 months and mark it with a single vertical mark on the 100 mm horizontal visual analogue scale, where 0 mm represented absence of pain and 100 mm indicated unbearable pain. Higher score indicated more pain. Change from baseline in pain VAS score after administration of fourth dose of study drug is reported in this outcome measure.', 'unitOfMeasure': 'millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis set included all participants who received at least 1 dose of Sayana and evaluated for efficacy at least once. Here, "Overall number of participants analyzed" = participants who were administered with Sayana for the management of endometriosis-associated pain at Month 12.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sayana', 'description': 'Participants were administered with Sayana (medroxyprogesterone acetate) as part of routine practice in Korean health care centers by accredited physicians per the local product document.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '362'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '337'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '185'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '177'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'Violated the usage and dosage', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'No longer met inclusion/exclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Administered Sayana prior to the contract', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'Change to other contraception methods', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Discontinuation due to no pain', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Refusal of administration due to unknown reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '69'}]}, {'type': 'Discontinuation of contraception', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}]}], 'recruitmentDetails': "Participants were planned to be observed for 6 months from enrolment date but few of them were followed beyond 6 months, up to a maximum of 12 months based on investigators' judgement", 'preAssignmentDetails': 'Main objective of this study was to conduct safety analysis of Sayana injection in participants during usual care setting so data for both groups (pregnancy prevention group and endometriosis associated pain group) were combined and presented. For efficacy analysis data was collected separately for both groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Sayana', 'description': 'Participants were administered with Sayana (medroxyprogesterone acetate) as part of routine practice in Korean health care centers by accredited physicians per the local product document.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '34.92', 'spread': '8.62', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '337', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of Sayana.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-21', 'size': 691314, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-05-14T10:35', 'hasProtocol': True}, {'date': '2020-04-27', 'size': 814731, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-05-14T10:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 362}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-14', 'studyFirstSubmitDate': '2014-04-01', 'resultsFirstSubmitDate': '2021-05-14', 'studyFirstSubmitQcDate': '2014-04-01', 'lastUpdatePostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-14', 'studyFirstPostDateStruct': {'date': '2014-04-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline up to a maximum of 12 months', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. AEs included both serious and all non-serious adverse events.'}, {'measure': 'Number of Participants Discontinued From Study Due to AEs', 'timeFrame': 'Baseline up to a maximum of 12 months', 'description': 'Participants who discontinued permanently from the study due to AEs are reported. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.'}, {'measure': 'Number of Participants Used Concomitant Medications for Treating AEs', 'timeFrame': 'Baseline up to a maximum of 12 months', 'description': 'Number of participants taking any medications other than Sayana (concomitant medication) to treat AEs are reported.'}, {'measure': 'Number of Participants With Clinically Significant Laboratory Test Abnormalities', 'timeFrame': 'Baseline up to a maximum of 12 months', 'description': "Laboratory tests included hematology, biochemistry, and urinalysis. Clinical significance was identified by investigators' judgements based on laboratory test results."}, {'measure': 'Percentage of Participants Who Became Pregnant Over Observation Period', 'timeFrame': 'Baseline up to 12 months', 'description': 'The cumulative percent of participants who became pregnant over observation period was calculated as 100\\*(1- Kaplan-Meier curve at month 12), where the Kaplan-Meier (KM) method for estimating survival function was applied to time-to-pregnancy.'}, {'measure': 'Rate of Pregnancies Per 100 Participant-years of Follow-up', 'timeFrame': 'Baseline up to 12 months', 'description': 'Pregnancies per 100 person-years of follow-up defined as major events, incidence rate was calculated as: 100\\*(total number of participants with effectiveness endpoint)/(total person-years of participants included in the effectiveness analysis set) where total person-years is equal to (last evaluation date of outcome - first date of administration +1)/365.25 for all participants in the effective analysis set.'}, {'measure': 'Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of First Dose (Month 3) of Study Drug', 'timeFrame': 'Baseline, Month 3', 'description': 'Participants were asked to indicate the subjective level of endometriosis pain looking back at the last 3 months and mark it with a single vertical mark on the 100 millimeter (mm) horizontal visual analogue scale, where 0 mm represented absence of pain and 100 mm indicated unbearable pain. Higher score indicated more pain. Change from baseline in pain VAS score after administration of first dose of study drug is reported in this outcome measure.'}, {'measure': 'Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Second Dose (Month 6) of Study Drug', 'timeFrame': 'Baseline, Month 6', 'description': 'Participants were asked to indicate the subjective level of endometriosis pain looking back at the last 3 months and mark it with a single vertical mark on the 100 mm horizontal visual analogue scale, where 0 mm represented absence of pain and 100 mm indicated unbearable pain. Higher score indicated more pain. Change from baseline in pain VAS score after administration of second dose of study drug is reported in this outcome measure.'}, {'measure': 'Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Third Dose (Month 9) of Study Drug', 'timeFrame': 'Baseline, Month 9', 'description': 'Participants were asked to indicate the subjective level of endometriosis pain looking back at the last 3 months and mark it with a single vertical mark on the 100 mm horizontal visual analogue scale, where 0 mm represented absence of pain and 100 mm indicated unbearable pain. Higher score indicated more pain. Change from baseline in pain VAS score after administration of third dose of study drug is reported in this outcome measure.'}, {'measure': 'Change From Baseline in in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Fourth Dose (Month 12) of Study Drug', 'timeFrame': 'Baseline, Month 12', 'description': 'Participants were asked to indicate the subjective level of endometriosis pain looking back at the last 3 months and mark it with a single vertical mark on the 100 mm horizontal visual analogue scale, where 0 mm represented absence of pain and 100 mm indicated unbearable pain. Higher score indicated more pain. Change from baseline in pain VAS score after administration of fourth dose of study drug is reported in this outcome measure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sayana', 'Pregnancy', 'Contraception', 'Endometriosis-associated pain', 'PMS', 'Post Marketing Surveillance'], 'conditions': ['Product Surveillance, Postmarketing']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6791036&StudyName=Post%20Marketing%20Surveillance%20To%20Observe%20Safety%20And%20Efficacy%20Of%20Sayana%28registered%29%20Used%20For%20Contraception%20And%20Management%20Of%20Endometriosis-associated%20Pain', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Post Marketing Surveillance To Observe Safety And Efficacy Of Sayana® Used For Contraception And Management Of Endometriosis-Associated Pain', 'detailedDescription': 'Post Marketing Surveillance required by Korea MFDS regulation. Select among patients who randomly visit the site who meet the inclusion/exclusion criteria.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '0 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women subjects who are initiating treatment with Sayana® for the first time as per the local product document for usage', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Subjects or legally authorized representatives of pediatric subjects agree to provide written informed consent form (ie, data privacy statement).\n\n2.Women subjects who are initiating treatment with Sayana® for the first time as per the local product document for usage\n\nExclusion Criteria:\n\n* Known or suspected pregnancy.\n* Undiagnosed vaginal bleeding.\n* Known or suspected malignancy of breast.\n* Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular 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126.9784}}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06973', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Chung-Ang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07985', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Ewha Womans University Mokdong Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital, Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-913', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'CHA Gangnam Medical Center, CHA University', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-932', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Roen Clinic', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '137-809', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Nana Clinic', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '139-832', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Avenue Clinic', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. 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