Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-29 @ 8:31 AM
Study NCT ID:
NCT02432404
Status:
COMPLETED
Last Update Posted:
2025-02-05
First Post:
2015-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of a Vaginal Contraceptive Ring on Vaginal Microbiota and Local Immunity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016585', 'term': 'Vaginosis, Bacterial'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014627', 'term': 'Vaginitis'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C516519', 'term': 'NuvaRing'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cjohnsto@uw.edu', 'phone': '206-520-4340', 'title': 'Christine Johnston', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'High rate of participant withdrawal from the study Single center experience'}}, 'adverseEventsModule': {'timeFrame': '7 months', 'eventGroups': [{'id': 'EG000', 'title': 'NuvaRing CVR Use', 'description': 'Participants could choose to use NuvaringCVR for 3 weeks, remove for 1 week, then replace, or to use continuously.', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 81, 'otherNumAffected': 8, 'seriousNumAtRisk': 81, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vulvovaginal candidiasis', 'notes': 'Number of participants with vulvovaginal candidiasis at Final study visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}, {'units': 'swabs', 'counts': [{'value': '2895', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NuvaRing CVR Use', 'description': 'Participants could choose to use NuvaringCVR for 3 weeks, remove for 1 week, then replace, or to use continuously.'}], 'classes': [{'title': 'G. vaginalis Baseline (M1-M2)', 'categories': [{'measurements': [{'value': '5.59', 'spread': '2.27', 'groupId': 'OG000'}]}]}, {'title': 'G. vaginalis Nuvaring (M2-M3)', 'categories': [{'measurements': [{'value': '5.22', 'spread': '2.42', 'groupId': 'OG000'}]}]}, {'title': 'G. vaginalis Nuvaring (M3-M6)', 'categories': [{'measurements': [{'value': '4.91', 'spread': '2.13', 'groupId': 'OG000'}]}]}, {'title': 'L. iners Baseline (M1-M2)', 'categories': [{'measurements': [{'value': '7.41', 'spread': '2.80', 'groupId': 'OG000'}]}]}, {'title': 'L. iners Nuvaring (M2-M3)', 'categories': [{'measurements': [{'value': '7.49', 'spread': '2.90', 'groupId': 'OG000'}]}]}, {'title': 'L. iners Nuvaring (M3-M6)', 'categories': [{'measurements': [{'value': '7.89', 'spread': '2.32', 'groupId': 'OG000'}]}]}, {'title': 'L. crispatus Baseline (M1-M2)', 'categories': [{'measurements': [{'value': '5.60', 'spread': '3.42', 'groupId': 'OG000'}]}]}, {'title': 'L. crispatus Nuvaring (M2-M3)', 'categories': [{'measurements': [{'value': '5.82', 'spread': '3.42', 'groupId': 'OG000'}]}]}, {'title': 'L. crispatus Nuvaring (M3-M6)', 'categories': [{'measurements': [{'value': '5.94', 'spread': '3.05', 'groupId': 'OG000'}]}]}, {'title': 'L. jensenii Baseline (M1-M2)', 'categories': [{'measurements': [{'value': '4.85', 'spread': '2.74', 'groupId': 'OG000'}]}]}, {'title': 'L. jensenii Nuvaring (M2-M3)', 'categories': [{'measurements': [{'value': '4.97', 'spread': '2.76', 'groupId': 'OG000'}]}]}, {'title': 'L. jensenii Nuvaring (M3-M6)', 'categories': [{'measurements': [{'value': '5.23', 'spread': '2.27', 'groupId': 'OG000'}]}]}, {'title': 'Megasphaera Baseline (M1-M2)', 'categories': [{'measurements': [{'value': '2.50', 'spread': '1.70', 'groupId': 'OG000'}]}]}, {'title': 'Megasphaera Nuvaring (M2-M3)', 'categories': [{'measurements': [{'value': '2.60', 'spread': '1.83', 'groupId': 'OG000'}]}]}, {'title': 'Megasphaera Nuvaring (M3-M6)', 'categories': [{'measurements': [{'value': '2.20', 'spread': '0.87', 'groupId': 'OG000'}]}]}, {'title': 'BVAB2 Baseline (M1-M2)', 'categories': [{'measurements': [{'value': '2.22', 'spread': '1.27', 'groupId': 'OG000'}]}]}, {'title': 'BVAB2 Nuvaring (M2-M3)', 'categories': [{'measurements': [{'value': '2.29', 'spread': '1.17', 'groupId': 'OG000'}]}]}, {'title': 'BVAB2 Nuvaring (M3-M6)', 'categories': [{'measurements': [{'value': '2.12', 'spread': '0.56', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.37', 'pValueComment': 'p\\<0.05 is considered statistically significant.', 'groupDescription': 'Mean quantity of G. vaginalis at baseline and during Nuvaring Use (M2-M3)', 'statisticalMethod': 'Random effects mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.'}, {'pValue': '0.008', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.69', 'pValueComment': 'p\\<0.05 is considered statistically significant.', 'groupDescription': 'Mean quantity of G. vaginalis at baseline and during Nuvaring Use (M3-M6)', 'statisticalMethod': 'Random effects mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.'}, {'pValue': '0.662', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.08', 'pValueComment': 'p\\<0.05 is considered statistically significant.', 'groupDescription': 'Mean quantity of L. iners at baseline and during Nuvaring Use (M2-M3)', 'statisticalMethod': 'Random effects mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.'}, {'pValue': '0.41', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.48', 'pValueComment': 'p\\<0.05 is considered statistically significant.', 'groupDescription': 'Mean quantity of L. iners at baseline and during Nuvaring Use (M3-M6)', 'statisticalMethod': 'Random effects mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.'}, {'pValue': '0.164', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.23', 'pValueComment': 'p\\<0.05 is considered statistically significant.', 'groupDescription': 'Mean quantity of L. crispatus at baseline and during Nuvaring Use (M2-M3)', 'statisticalMethod': 'Random effects mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.'}, {'pValue': '0.183', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.35', 'pValueComment': 'p\\<0.05 is considered statistically significant.', 'groupDescription': 'Mean quantity of L. crispatus at baseline and during Nuvaring Use (M3-M6)', 'statisticalMethod': 'Random effects mixed model', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.506', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.12', 'pValueComment': 'p\\<0.05 is considered statistically significant.', 'groupDescription': 'Mean quantity of L. jensenii at baseline and during Nuvaring Use (M2-M3)', 'statisticalMethod': 'Random effects mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.'}, {'pValue': '0.119', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.38', 'pValueComment': 'p\\<0.05 is considered statistically significant.', 'groupDescription': 'Mean quantity of L. jensenii at baseline and during Nuvaring Use (M3-M6)', 'statisticalMethod': 'Random effects mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.'}, {'pValue': '0.510', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.10', 'pValueComment': 'p\\<0.05 is considered statistically significant.', 'groupDescription': 'Mean quantity of Megasphaera at baseline and during Nuvaring Use (M2-M3)', 'statisticalMethod': 'Random effects mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.'}, {'pValue': '0.168', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.30', 'pValueComment': 'p\\<0.05 is considered statistically significant.', 'groupDescription': 'Mean quantity of Megasphaera at baseline and during Nuvaring Use (M3-M6)', 'statisticalMethod': 'Random effects mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.'}, {'pValue': '0.454', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.07', 'pValueComment': 'p\\<0.05 is considered statistically significant.', 'groupDescription': 'Mean quantity of BVAB2 at baseline and during Nuvaring Use (M2-M3)', 'statisticalMethod': 'Random effects mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.'}, {'pValue': '0.471', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.10', 'pValueComment': 'p\\<0.05 is considered statistically significant.', 'groupDescription': 'Mean quantity of BVAB2 at baseline and during Nuvaring Use (M3-M6)', 'statisticalMethod': 'Random effects mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 8 months', 'description': 'Change in Log10 quantity of bacteria detected (L. crisptatus, L. jensenii, L. iners, G. vaginalis, Megasphaera spp. BVAB2)', 'unitOfMeasure': 'log10 copies/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'swabs', 'denomUnitsSelected': 'swabs', 'populationDescription': 'Participants who initiated the ring and had at least one followup month in M3/4/5/6'}, {'type': 'SECONDARY', 'title': 'Number of Visits With BV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}, {'units': 'Visits', 'counts': [{'value': '320', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NuvaRing CVR Use', 'description': 'Participants could choose to use CVR for 3 weeks, remove for 1 week, then replace, or to use continuously.\n\nNuvaRing'}], 'classes': [{'title': 'Visits with BV pre-CVR', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Visits with BV at M3', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Visits with BV at M4/5/6', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Up to 8 months', 'description': 'Number of visits with BV prior to use of NuvaRing CVR compared to during NuvaRing CVR use.', 'unitOfMeasure': 'Visits', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Visits', 'denomUnitsSelected': 'Visits', 'populationDescription': 'Among participants who initiated the ring and had at least one followup month in M3/4/5/6'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NuvaRing CVR Use', 'description': 'Participants could choose to use CVR for 3 weeks, remove for 1 week, then replace, or to use continuously.\n\nNuvaRing'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}]}, {'type': 'Initiated Nuvaring CVR', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}]}], 'preAssignmentDetails': 'After 1 month baseline observation, participants initiated the CVR and were followed monthly for 4 months'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'NuvaRing CVR Use', 'description': 'Participants could choose to use CVR for 3 weeks, remove for 1 week, then replace, or to use continuously.\n\nNuvaRing'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '34'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': '9 persons had missing age'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '81', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '72', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}]}], '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': '23', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Self-reported.\n\nIn this analysis, participants selected "other" as a category. This will be indicated in the more than one race" count, since "other" is not available.', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-27', 'size': 563228, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-04-05T19:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2021-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-14', 'studyFirstSubmitDate': '2015-04-24', 'resultsFirstSubmitDate': '2023-04-17', 'studyFirstSubmitQcDate': '2015-04-28', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-14', 'studyFirstPostDateStruct': {'date': '2015-05-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests', 'timeFrame': 'Up to 8 months', 'description': 'Change in Log10 quantity of bacteria detected (L. crisptatus, L. jensenii, L. iners, G. vaginalis, Megasphaera spp. BVAB2)'}], 'secondaryOutcomes': [{'measure': 'Number of Visits With BV', 'timeFrame': 'Up to 8 months', 'description': 'Number of visits with BV prior to use of NuvaRing CVR compared to during NuvaRing CVR use.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HSV-2', 'Contraceptive Vaginal Ring'], 'conditions': ['Bacterial Vaginosis']}, 'referencesModule': {'references': [{'pmid': '15339769', 'type': 'BACKGROUND', 'citation': 'Veres S, Miller L, Burington B. A comparison between the vaginal ring and oral contraceptives. Obstet Gynecol. 2004 Sep;104(3):555-63. doi: 10.1097/01.AOG.0000136082.59644.13.'}, {'pmid': '18614873', 'type': 'BACKGROUND', 'citation': 'Atashili J, Poole C, Ndumbe PM, Adimora AA, Smith JS. Bacterial vaginosis and HIV acquisition: a meta-analysis of published studies. AIDS. 2008 Jul 31;22(12):1493-501. doi: 10.1097/QAD.0b013e3283021a37.'}, {'pmid': '22745608', 'type': 'BACKGROUND', 'citation': 'Cohen CR, Lingappa JR, Baeten JM, Ngayo MO, Spiegel CA, Hong T, Donnell D, Celum C, Kapiga S, Delany S, Bukusi EA. Bacterial vaginosis associated with increased risk of female-to-male HIV-1 transmission: a prospective cohort analysis among African couples. PLoS Med. 2012;9(6):e1001251. doi: 10.1371/journal.pmed.1001251. Epub 2012 Jun 26.'}, {'pmid': '21975269', 'type': 'BACKGROUND', 'citation': 'Heffron R, Donnell D, Rees H, Celum C, Mugo N, Were E, de Bruyn G, Nakku-Joloba E, Ngure K, Kiarie J, Coombs RW, Baeten JM; Partners in Prevention HSV/HIV Transmission Study Team. Use of hormonal contraceptives and risk of HIV-1 transmission: a prospective cohort study. Lancet Infect Dis. 2012 Jan;12(1):19-26. doi: 10.1016/S1473-3099(11)70247-X. Epub 2011 Oct 3.'}, {'pmid': '24023807', 'type': 'BACKGROUND', 'citation': 'Vodstrcil LA, Hocking JS, Law M, Walker S, Tabrizi SN, Fairley CK, Bradshaw CS. Hormonal contraception is associated with a reduced risk of bacterial vaginosis: a systematic review and meta-analysis. PLoS One. 2013 Sep 4;8(9):e73055. doi: 10.1371/journal.pone.0073055. eCollection 2013.'}]}, 'descriptionModule': {'briefSummary': 'To assess potential benefits associated with both intermittent (use for 3 weeks, remove for 1 week, as defined in the package insert) and continuous (use for 4 weeks, then replace) CVR use among women either with BV or at high risk for BV. The investigators will also recruit women who are HSV2-infected.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18-40 year old women\n* BV+ by Amsel criteria and Nugent score OR history of BV in the prior 6 months\n* Willing to use the NuvaRing as directed\n* Not intending or wishing to become pregnant over the course of the study\n* Capable of providing written informed consent\n\nExclusion Criteria:\n\n* Current pregnancy\n* Desire/intent to become pregnant over the course of the study\n* Women who are less than 6 weeks postpartum\n* Contraindications to hormonal contraceptive use per package insert, including history of deep vein thrombosis, smoking in women older than 35 years\n* Current IUD\n* Unable to comprehend consent material because of language barrier or psychological difficulty'}, 'identificationModule': {'nctId': 'NCT02432404', 'briefTitle': 'Effects of a Vaginal Contraceptive Ring on Vaginal Microbiota and Local Immunity', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Effects of a Vaginal Contraceptive Ring on Vaginal Microbiota and Local Immunity', 'orgStudyIdInfo': {'id': 'STUDY00003584'}, 'secondaryIdInfos': [{'id': 'U19AI113173', 'link': 'https://reporter.nih.gov/quickSearch/U19AI113173', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cyclic NuvaRing CVR Use', 'description': 'CVR use for 3 weeks, remove for 1 week, then replace', 'interventionNames': ['Drug: NuvaRing']}, {'type': 'EXPERIMENTAL', 'label': 'Continuous NuvaRing CVR Use', 'description': 'CVR use for 4 weeks, then replace', 'interventionNames': ['Drug: NuvaRing']}], 'interventions': [{'name': 'NuvaRing', 'type': 'DRUG', 'armGroupLabels': ['Continuous NuvaRing CVR Use', 'Cyclic NuvaRing CVR Use']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'UW Virology Research Clinic', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Christine Johnston, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Medicine/Division of Allergy and Infectious Diseases', 'investigatorFullName': 'Christine Johnston', 'investigatorAffiliation': 'University of Washington'}}}}