Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2026-02-24 @ 3:14 PM
Study NCT ID:
NCT03034057
Status:
COMPLETED
Last Update Posted:
2019-10-18
First Post:
2017-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sayana Press UK Self-Injection Study
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': 'Up to 1 year', 'description': 'The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.', 'eventGroups': [{'id': 'EG000', 'title': 'Sayana Press', 'description': 'Following product use education and a supervised initial self-injection at the baseline visit, participants self-injected Sayana Press in the home setting every 3 months (at Month 3, Month 6 and Month 9) and returned for a final study visit at Month 12.', 'otherNumAtRisk': 169, 'deathsNumAtRisk': 169, 'otherNumAffected': 60, 'seriousNumAtRisk': 169, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 25, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA21.1'}, {'term': 'Injection site mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA21.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA21.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA21.1'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA21.1'}], 'seriousEvents': [{'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA21.1'}, {'term': 'Mastitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA21.1'}, {'term': 'Ovarian germ cell teratoma benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA21.1'}, {'term': 'Cauda equina syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA21.1'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Successful Self-Injections Performed of All Attempts at Home on Schedule (Full Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sayana Press', 'description': 'Following product use education and a supervised initial self-injection at the baseline visit, participants self-injected Sayana Press in the home setting every 3 months (at Month 3, Month 6 and Month 9) and returned for a final study visit at Month 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.8', 'groupId': 'OG000', 'lowerLimit': '85.1', 'upperLimit': '91.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 year', 'description': 'Each participant had a maximum of 3 home self-injections, each of which was defined as a success or failure. A success was defined as a home self-injection that was successfully performed by the participant at home and on schedule (13 week interval +/- 1 week) where all attempts were included in the denominator. If the participant attempted but was unable to administer the self-injection at home and had it performed instead at the clinic, then these were classed as failures. This outcome measure was analyzed by generalized estimating equation (GEE) model using participant as the clustering variable. The GEE model used the logit link and contained an intercept term. The 95% confidence interval (CI) for the intercept was transformed to a 95% CI for the self-injection success rate.', 'unitOfMeasure': 'Percentage of all attempts at home', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included participants who enrolled into the study.'}, {'type': 'PRIMARY', 'title': 'Percentage of Successful Self-Injections Performed of All Attempts at Home on Schedule (Sensitivity Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sayana Press', 'description': 'Following product use education and a supervised initial self-injection at the baseline visit, participants self-injected Sayana Press in the home setting every 3 months (at Month 3, Month 6 and Month 9) and returned for a final study visit at Month 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.3', 'groupId': 'OG000', 'lowerLimit': '85.6', 'upperLimit': '92.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 year', 'description': 'Each participant had a maximum of 3 home self-injections, each of which was defined as a success or failure. A success was defined as a home self-injection that was successfully performed by the participant at home and on schedule (13 week interval +/- 1 week) where all attempts were included in the denominator. If the participant attempted but was unable to administer the self-injection at home and had it performed instead at the clinic, then these were classed as failures. This outcome measure was analyzed by GEE model using participant as the clustering variable. The GEE model used the logit link and contained an intercept term. The 95% CI for the intercept was transformed to a 95% CI for the self-injection success rate. The sensitivity analysis was conducted to eliminate the data from the discontinued site due to ongoing Good Clinical Practice (GCP) violations.', 'unitOfMeasure': 'Percentage of all attempts at home', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included participants who enrolled into the study. Participants at sites which required closure during study due to GCP violations were excluded from the analysis population.'}, {'type': 'SECONDARY', 'title': 'Continuation Rate for the Method (Self-injection With Sayana Press) at 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sayana Press', 'description': 'Following product use education and a supervised initial self-injection at the baseline visit, participants self-injected Sayana Press in the home setting every 3 months (at Month 3, Month 6 and Month 9) and returned for a final study visit at Month 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.5', 'groupId': 'OG000', 'lowerLimit': '59.8', 'upperLimit': '74.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Continuation rate for the method at 1 year equals: (\\[the number of participants who received all 4 injections and had not discontinued by 12 months\\] / \\[total number of participants in the study\\]) \\*100%. A 95% CI was calculated along with the continuation rate using normal approximation to the binominal.', 'unitOfMeasure': 'Percentage of total participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included participants who enrolled into the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sayana Press', 'description': 'Following product use education and a supervised initial self-injection at the baseline visit, participants self-injected Sayana Press in the home setting every 3 months (at Month 3, Month 6 and Month 9) and returned for a final study visit at Month 12.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '169'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Not defined', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'Medication error without associated AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'A total of 169 adult women participants of reproductive age (18 to 45 years) were enrolled in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Sayana Press', 'description': 'Following product use education and a supervised initial self-injection at the baseline visit, participants self-injected Sayana Press in the home setting every 3 months (at Month 3, Month 6 and Month 9) and returned for a final study visit at Month 12.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.1', 'spread': '7.26', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '169', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '154', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '163', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline analysis population included all participants who enrolled into the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-31', 'size': 1985665, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-09-23T19:19', 'hasProtocol': False}, {'date': '2017-01-26', 'size': 4217087, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-09-23T19:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 169}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-23', 'studyFirstSubmitDate': '2017-01-24', 'resultsFirstSubmitDate': '2019-09-23', 'studyFirstSubmitQcDate': '2017-01-24', 'lastUpdatePostDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-23', 'studyFirstPostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Successful Self-Injections Performed of All Attempts at Home on Schedule (Full Analysis Set)', 'timeFrame': 'Up to 1 year', 'description': 'Each participant had a maximum of 3 home self-injections, each of which was defined as a success or failure. A success was defined as a home self-injection that was successfully performed by the participant at home and on schedule (13 week interval +/- 1 week) where all attempts were included in the denominator. If the participant attempted but was unable to administer the self-injection at home and had it performed instead at the clinic, then these were classed as failures. This outcome measure was analyzed by generalized estimating equation (GEE) model using participant as the clustering variable. The GEE model used the logit link and contained an intercept term. The 95% confidence interval (CI) for the intercept was transformed to a 95% CI for the self-injection success rate.'}, {'measure': 'Percentage of Successful Self-Injections Performed of All Attempts at Home on Schedule (Sensitivity Analysis)', 'timeFrame': 'Up to 1 year', 'description': 'Each participant had a maximum of 3 home self-injections, each of which was defined as a success or failure. A success was defined as a home self-injection that was successfully performed by the participant at home and on schedule (13 week interval +/- 1 week) where all attempts were included in the denominator. If the participant attempted but was unable to administer the self-injection at home and had it performed instead at the clinic, then these were classed as failures. This outcome measure was analyzed by GEE model using participant as the clustering variable. The GEE model used the logit link and contained an intercept term. The 95% CI for the intercept was transformed to a 95% CI for the self-injection success rate. The sensitivity analysis was conducted to eliminate the data from the discontinued site due to ongoing Good Clinical Practice (GCP) violations.'}], 'secondaryOutcomes': [{'measure': 'Continuation Rate for the Method (Self-injection With Sayana Press) at 1 Year', 'timeFrame': '1 year', 'description': 'Continuation rate for the method at 1 year equals: (\\[the number of participants who received all 4 injections and had not discontinued by 12 months\\] / \\[total number of participants in the study\\]) \\*100%. A 95% CI was calculated along with the continuation rate using normal approximation to the binominal.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Contraception']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=A6791040', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'A one-year evaluation of Sayana Press self injection in women of reproductive age in the United Kingdom (UK).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women aged 18 to 45 years of age who are willing to attempt Sayana Press self-injection at home;\n* women who are likely to be successful on a DMPA self-injection program, based on the opinion of the investigator;\n* not planning to move out of the area for at least 12 months;\n* willing to be contacted by the clinical staff at work or at home;\n* evidence of a personally signed and dated Informed Consent Document (ICD) indicating that the subject has been informed of all pertinent aspects of the study;\n* subjects who are willing and able to comply with scheduled visits, treatment plan and other study procedures\n\nExclusion Criteria:\n\n* a pre-existing medical condition that would interfere with participation in the study or pose a risk to the subject, including hypersensitivity to MPA or any constituents of Sayana Press;\n* known or suspected malignancy of genital organs;\n* known or suspected malignancy of the breast;\n* history of cerebrovascular disease\n* metabolic bone disease\n* a contraindication to DMPA (UK Medical Eligibility Criteria Category 3 or 4) such as:\n* Multiple risk factors for cardiovascular disease (e.g. older age, smoking, diabetes, obesity, hypertension)\n* current and history of ischaemic heart disease;\n* stroke (history of cerebrovascular accident, including transient ischaemic attack);\n* unexplained vaginal bleeding;\n* current or history of breast cancer;\n* diabetic nephropathy, neuropathy, retinopathy or other diabetic vascular disease;\n* severe (decompensated) liver cirrhosis;\n* hepatocellular adenoma;\n* hepatoma;\n* Systemic Lupus Erythematosus (positive or unknown antiphospholipid antibodies; severe thrombocytopenia;\n* subjects who are investigational centre staff members directly involved in the conduct of the study and their family members, centre staff members otherwise supervised by the investigator, or subjects who are Pfizer employees involved in the conduct of the study;\n* participation in other studies involving investigational drug(s) within 30 days prior to study entry and/or during study participation;\n* patients who plan to get pregnant within two years of study;\n* breastfeeding and pregnant subjects;\n* other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the subject inappropriate for entry into this study.'}, 'identificationModule': {'nctId': 'NCT03034057', 'briefTitle': 'Sayana Press UK Self-Injection Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'PHASE IV OPEN LABEL SINGLE GROUP ONE YEAR STUDY OF HOME SELF-INJECTION WITH SAYANA (REGISTERED) PRESS IN ADULT WOMEN OF REPRODUCTIVE AGE - A PRAGMATIC CLINICAL TRIAL', 'orgStudyIdInfo': {'id': 'A6791040'}, 'secondaryIdInfos': [{'id': '2017-000051-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'sayana press', 'description': 'single arm', 'interventionNames': ['Drug: Sayana Press']}], 'interventions': [{'name': 'Sayana Press', 'type': 'DRUG', 'description': 'Sayana Press in the Uniject injection system', 'armGroupLabels': ['sayana press']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PL23 1DT', 'city': 'Fowey', 'state': 'Cornwall', 'country': 'United Kingdom', 'facility': 'Fowey Clinical Research Office', 'geoPoint': {'lat': 50.33634, 'lon': -4.6386}}, {'zip': 'PL23 1DT', 'city': 'Fowey', 'state': 'Cornwall', 'country': 'United Kingdom', 'facility': 'Fowey River Practice', 'geoPoint': {'lat': 50.33634, 'lon': -4.6386}}, {'zip': 'PL26 7RL', 'city': 'St Austell', 'state': 'Cornwall', 'country': 'United Kingdom', 'facility': 'Brannel Surgery', 'geoPoint': {'lat': 50.3425, 'lon': -4.77442}}, {'zip': 'PL11 2TB', 'city': 'Torpoint', 'state': 'Cornwall', 'country': 'United Kingdom', 'facility': 'Rame Medical Ltd, Penntorr Health', 'geoPoint': {'lat': 50.37505, 'lon': -4.19566}}, {'zip': 'PL11 2TB', 'city': 'Torpoint', 'state': 'Cornwall', 'country': 'United Kingdom', 'facility': 'Rame Medical Ltd', 'geoPoint': {'lat': 50.37505, 'lon': -4.19566}}, {'zip': 'PL5 3JB', 'city': 'Plymouth', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'Knowle House Surgery', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'zip': 'KA2 0BE', 'city': 'Kilmarnock', 'state': 'EAST Ayrshire', 'country': 'United Kingdom', 'facility': 'NHS Ayrshire & Arran, University Hospital Crosshouse', 'geoPoint': {'lat': 55.61171, 'lon': -4.49581}}, {'zip': 'PO5 3ND', 'city': 'Southsea', 'state': 'Hampshire', 'country': 'United Kingdom', 'facility': 'Trafalgar Medical Group Practice', 'geoPoint': {'lat': 50.78351, 'lon': -1.09071}}, {'zip': 'IV2 3JH', 'city': 'Inverness', 'state': 'Highland', 'country': 'United Kingdom', 'facility': 'NHS Highland Clinical Research Facility', 'geoPoint': {'lat': 57.47908, 'lon': -4.22398}}, {'zip': 'CT1 3NG', 'city': 'Canterbury', 'state': 'KENT', 'country': 'United Kingdom', 'facility': 'Kent Community Health NHS 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Ayrshire & Arran, Ayrshire Central Hospital', 'geoPoint': {'lat': 55.6194, 'lon': -4.65508}}, {'zip': 'YO18 8BL', 'city': 'Pickering', 'state': 'North Yorkshire', 'country': 'United Kingdom', 'facility': 'Pickering Medical Practice', 'geoPoint': {'lat': 54.25, 'lon': -0.76667}}, {'zip': 'BA32UH', 'city': 'Radstock', 'state': 'Somerset', 'country': 'United Kingdom', 'facility': "St Chad's Surgery", 'geoPoint': {'lat': 51.292, 'lon': -2.445}}, {'zip': 'NE1 4LP', 'city': 'Newcastle upon Tyne', 'state': 'TYNE and WEAR', 'country': 'United Kingdom', 'facility': 'The Newcastle upon Tyne Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'NE1 6ND', 'city': 'Newcastle upon Tyne', 'state': 'TYNE and WEAR', 'country': 'United Kingdom', 'facility': 'The Newcastle upon Tyne Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'B15 2TH', 'city': 'Birmingham', 'state': 'WEST Midlands', 'country': 'United Kingdom', 'facility': 'University Hospitals Birmingham NHS Foundation Trust', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'B4 6DH', 'city': 'Birmingham', 'state': 'WEST Midlands', 'country': 'United Kingdom', 'facility': 'University Hospitals Birmingham NHS Foundation Trust', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'DY1 2QD', 'city': 'Dudley', 'state': 'WEST Midlands', 'country': 'United Kingdom', 'facility': 'Eve Hill Medical Practice', 'geoPoint': {'lat': 52.5, 'lon': -2.08333}}, {'zip': 'BA15 1DQ', 'city': 'Bradford-on-Avon', 'state': 'Wiltshire', 'country': 'United Kingdom', 'facility': 'Bradford on Avon Health Centre', 'geoPoint': {'lat': 51.34772, 'lon': -2.25065}}, {'zip': 'SN14 6GT', 'city': 'Chippenham', 'state': 'Wiltshire', 'country': 'United Kingdom', 'facility': 'Hathaway Medical Centre', 'geoPoint': {'lat': 51.46, 'lon': -2.12472}}, {'zip': 'BA148QA', 'city': 'Trowbridge', 'state': 'Wiltshire', 'country': 'United Kingdom', 'facility': 'Trowbridge Health Centre', 'geoPoint': {'lat': 51.31889, 'lon': -2.20861}}, {'zip': 'BA13 3FQ', 'city': 'Westbury', 'state': 'Wiltshire', 'country': 'United Kingdom', 'facility': 'Westbury Group Practice', 'geoPoint': {'lat': 51.26, 'lon': -2.1875}}, {'zip': 'G20 0XA', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'CPS Research', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'E9 6SR', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Homerton University Hospital NHS Foundation Trust, Homerton', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', '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. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}