Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-29 @ 10:46 AM
Study NCT ID:
NCT02237950
Status:
COMPLETED
Last Update Posted:
2019-07-22
First Post:
2014-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)
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': 'D008795', 'term': 'Metronidazole'}, {'id': 'C480351', 'term': 'astodrimer'}], 'ancestors': [{'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jeremy.paull@starpharma.com', 'title': 'Dr Jeremy Paull', 'organization': 'Starpharma'}, 'certainAgreement': {'otherDetails': 'For multicenter studies, PIs can publish data only after study data are published collectively.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Safety population was all patients in the Intent-to-Treat population, but excluding those who later returned all the study medication unused.', 'eventGroups': [{'id': 'EG000', 'title': '1% SPL7013 Gel', 'description': 'Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks\n\nMetronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days\n\n1% SPL7013 Gel: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.', 'otherNumAtRisk': 294, 'otherNumAffected': 92, 'seriousNumAtRisk': 294, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Placebo Gel', 'description': 'Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks\n\nMetronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days\n\nPlacebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks', 'otherNumAtRisk': 291, 'otherNumAffected': 80, 'seriousNumAtRisk': 291, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 291, 'numAffected': 15}], 'organSystem': 'Infections and infestations'}, {'term': 'UTI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 291, 'numAffected': 10}], 'organSystem': 'Infections and infestations'}, {'term': 'Vulvovaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 291, 'numAffected': 35}], 'organSystem': 'Infections and infestations'}, {'term': 'Vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 291, 'numAffected': 16}], 'organSystem': 'Infections and infestations'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 291, 'numAffected': 20}], 'organSystem': 'Nervous system disorders'}], 'seriousEvents': [{'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': "Bartholin's abscess", 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 291, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Klebsiella bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 291, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Hemiplegic migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 291, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Blighted ovum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 291, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1% SPL7013 Gel', 'description': 'Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks\n\nMetronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days\n\n1% SPL7013 Gel: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.'}, {'id': 'OG001', 'title': 'Placebo Gel', 'description': 'Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks\n\nMetronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days\n\nPlacebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.015', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At or by the Week 16 visit', 'description': 'Number of participants with a recurrence of BV, where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population is the modified intent-to-treat analysis population. One patient was excluded compared with the intent-to-treat population because they were dispensed medication but returned all unused.'}, {'type': 'SECONDARY', 'title': 'Time to Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1% SPL7013 Gel', 'description': 'Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks\n\nMetronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days\n\n1% SPL7013 Gel: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.'}, {'id': 'OG001', 'title': 'Placebo Gel', 'description': 'Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks\n\nMetronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days\n\nPlacebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000', 'lowerLimit': '98', 'upperLimit': '111'}, {'value': '99', 'groupId': 'OG001', 'lowerLimit': '87', 'upperLimit': '106'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'At or by the Week 16 visit', 'description': 'Time to recurrence of BV (days), where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population is the modified intent-to-treat analysis population. One patient was excluded compared with the intent-to-treat population because they were dispensed medication but returned all unused.'}, {'type': 'SECONDARY', 'title': 'Recurrence of Patient-reported BV Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1% SPL7013 Gel', 'description': 'Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks\n\nMetronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days\n\n1% SPL7013 Gel: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.'}, {'id': 'OG001', 'title': 'Placebo Gel', 'description': 'Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks\n\nMetronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days\n\nPlacebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At or by the Week 16 visit', 'description': 'Number of participants with self-reported BV symptoms (vaginal discharge and/or odor)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat, excluding patients with missing values.'}, {'type': 'SECONDARY', 'title': 'Recurrence of Individual Amsel Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1% SPL7013 Gel', 'description': 'Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks\n\nMetronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days\n\n1% SPL7013 Gel: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.'}, {'id': 'OG001', 'title': 'Placebo Gel', 'description': 'Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks\n\nMetronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days\n\nPlacebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At or by the Week 16 visit', 'description': 'Number of participants with positive individual Amsel criterion\n\n\\- Clue cells representing at least 20% of total epithelial cells', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat, excluding patients with missing values.'}, {'type': 'SECONDARY', 'title': 'Recurrence of BV as Determined by Presence of a Nugent Score of 7-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1% SPL7013 Gel', 'description': 'Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks\n\nMetronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days\n\n1% SPL7013 Gel: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.'}, {'id': 'OG001', 'title': 'Placebo Gel', 'description': 'Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks\n\nMetronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days\n\nPlacebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At or by the Week 16 visit', 'description': 'Number of participants with a recurrence of BV as determined by presence of a Nugent score of 7-10 (BV), where 0-3 is normal, and 4-6 is intermediate.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat, excluding patients with missing values.'}, {'type': 'SECONDARY', 'title': 'Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1% SPL7013 Gel', 'description': 'Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks\n\nMetronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days\n\n1% SPL7013 Gel: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.'}, {'id': 'OG001', 'title': 'Placebo Gel', 'description': 'Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks\n\nMetronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days\n\nPlacebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '194', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.059', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At or by the Week 24 visit', 'description': 'Number of participants with a recurrence of BV, where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population is the modified intent-to-treat analysis population. One patient was excluded compared with the intent-to-treat population because they were dispensed medication but returned all unused.'}, {'type': 'SECONDARY', 'title': 'Recurrence of BV According to the Composite Definition of at Least 3 Clinical Findings (Amsel Criteria) and a Nugent Score of 4-10.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1% SPL7013 Gel', 'description': 'Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks\n\nMetronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days\n\n1% SPL7013 Gel: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.'}, {'id': 'OG001', 'title': 'Placebo Gel', 'description': 'Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks\n\nMetronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days\n\nPlacebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At or by the Week 16 visit', 'description': 'Number of participants with a recurrence of BV according to the composite definition of at least 3 clinical findings (Amsel criteria) and a Nugent score of 4-10 (intermediate to BV), where 0-3 is normal.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat, excluding patients with missing values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Brief Index of Sexual Functioning for Women Questionnaire Composite Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1% SPL7013 Gel', 'description': 'Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks\n\nMetronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days\n\n1% SPL7013 Gel: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.'}, {'id': 'OG001', 'title': 'Placebo Gel', 'description': 'Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks\n\nMetronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days\n\nPlacebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '3.7'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-2.0', 'upperLimit': '2.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'Change from baseline in brief index of sexual functioning for women (BISF-W) questionnaire composite score. The composite score includes scores from dimensions (D) of thoughts/desire (D1, 0-12), arousal (D2, 0-12), frequency of sexual activity (D3, 0-12), receptivity/initiation (D4, 0-12), pleasure (D5, 0-12), relationship satisfaction (D6, 0-12), and any problems affecting sexual functioning (D7, 0-16). The composite score is calculated as D1+D2+D3+D4+D5+D6-D7 with a range of -16 to +75. A positive change in composite score from baseline to Week 16 reflects an improvement in sexual functioning, with a greater change in score indicating a greater improvement in sexual functioning.', 'unitOfMeasure': 'change in score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes only those participants who completed the survey, which was optional.'}, {'type': 'SECONDARY', 'title': 'Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1% SPL7013 Gel', 'description': 'Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks\n\nMetronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days\n\n1% SPL7013 Gel: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.'}, {'id': 'OG001', 'title': 'Placebo Gel', 'description': 'Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks\n\nMetronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days\n\nPlacebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline to end of Week 28', 'description': 'Number of participants with genitourinary AEs considered potentially related to study treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population was all patients in the Intent-to-Treat population, but excluding those who later returned all the study medication unused.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1% SPL7013 Gel', 'description': 'Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks\n\nMetronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days\n\n1% SPL7013 Gel: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.'}, {'id': 'FG001', 'title': 'Placebo Gel', 'description': 'Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks\n\nMetronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days\n\nPlacebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '295'}, {'groupId': 'FG001', 'numSubjects': '291'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '247'}, {'groupId': 'FG001', 'numSubjects': '243'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '48'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'BG000'}, {'value': '291', 'groupId': 'BG001'}, {'value': '585', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '1% SPL7013 Gel', 'description': 'Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks\n\nMetronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days\n\n1% SPL7013 Gel: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.'}, {'id': 'BG001', 'title': 'Placebo Gel', 'description': 'Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks\n\nMetronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days\n\nPlacebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.6', 'spread': '7.23', 'groupId': 'BG000'}, {'value': '31.6', 'spread': '6.99', 'groupId': 'BG001'}, {'value': '31.6', 'spread': '7.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '294', 'groupId': 'BG000'}, {'value': '291', 'groupId': 'BG001'}, {'value': '585', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis population is the modified intent-to-treat analysis population. One patient was excluded compared with the intent-to-treat population because they were dispensed medication but returned all unused.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 586}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'dispFirstSubmitDate': '2017-12-04', 'completionDateStruct': {'date': '2017-02-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-08', 'studyFirstSubmitDate': '2014-09-05', 'dispFirstSubmitQcDate': '2017-12-04', 'resultsFirstSubmitDate': '2019-05-07', 'studyFirstSubmitQcDate': '2014-09-11', 'dispFirstPostDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-14', 'studyFirstPostDateStruct': {'date': '2014-09-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings', 'timeFrame': 'At or by the Week 16 visit', 'description': 'Number of participants with a recurrence of BV, where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)'}], 'secondaryOutcomes': [{'measure': 'Time to Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings', 'timeFrame': 'At or by the Week 16 visit', 'description': 'Time to recurrence of BV (days), where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)'}, {'measure': 'Recurrence of Patient-reported BV Symptoms', 'timeFrame': 'At or by the Week 16 visit', 'description': 'Number of participants with self-reported BV symptoms (vaginal discharge and/or odor)'}, {'measure': 'Recurrence of Individual Amsel Criteria', 'timeFrame': 'At or by the Week 16 visit', 'description': 'Number of participants with positive individual Amsel criterion\n\n\\- Clue cells representing at least 20% of total epithelial cells'}, {'measure': 'Recurrence of BV as Determined by Presence of a Nugent Score of 7-10', 'timeFrame': 'At or by the Week 16 visit', 'description': 'Number of participants with a recurrence of BV as determined by presence of a Nugent score of 7-10 (BV), where 0-3 is normal, and 4-6 is intermediate.'}, {'measure': 'Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings', 'timeFrame': 'At or by the Week 24 visit', 'description': 'Number of participants with a recurrence of BV, where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)'}, {'measure': 'Recurrence of BV According to the Composite Definition of at Least 3 Clinical Findings (Amsel Criteria) and a Nugent Score of 4-10.', 'timeFrame': 'At or by the Week 16 visit', 'description': 'Number of participants with a recurrence of BV according to the composite definition of at least 3 clinical findings (Amsel criteria) and a Nugent score of 4-10 (intermediate to BV), where 0-3 is normal.'}, {'measure': 'Change From Baseline in Brief Index of Sexual Functioning for Women Questionnaire Composite Score', 'timeFrame': 'Baseline to Week 16', 'description': 'Change from baseline in brief index of sexual functioning for women (BISF-W) questionnaire composite score. The composite score includes scores from dimensions (D) of thoughts/desire (D1, 0-12), arousal (D2, 0-12), frequency of sexual activity (D3, 0-12), receptivity/initiation (D4, 0-12), pleasure (D5, 0-12), relationship satisfaction (D6, 0-12), and any problems affecting sexual functioning (D7, 0-16). The composite score is calculated as D1+D2+D3+D4+D5+D6-D7 with a range of -16 to +75. A positive change in composite score from baseline to Week 16 reflects an improvement in sexual functioning, with a greater change in score indicating a greater improvement in sexual functioning.'}, {'measure': 'Adverse Events (AEs)', 'timeFrame': 'From Baseline to end of Week 28', 'description': 'Number of participants with genitourinary AEs considered potentially related to study treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bacterial Vaginosis']}, 'descriptionModule': {'briefSummary': 'A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in women with a history of recurrent BV.', 'detailedDescription': 'Eligible participants, with both a history of recurrent BV and a current episode of BV, will receive a seven-day course of oral metronidazole. Participants who are successfully treated for their BV, and continue to be eligible, will be randomly assigned to receive either 1% SPL7013 Gel or placebo gel on alternate days at bed-time for 16 consecutive weeks.\n\nThe primary endpoint will be determined at the conclusion of this 16 week treatment phase.\n\nParticipants who experience a BV recurrence will be considered to have completed the study. Such participants will receive BV treatment in line with local practice and will not attend any further study visits.\n\nParticipants who successfully reach Week 16 without a BV recurrence will enter a 12-week follow-up phase to Week 28.\n\nParticipants will attend a study visit at 4-weekly intervals throughout the duration of the study to Week 28 (or up to the point of BV recurrence) to assess recurrence of BV and adverse events.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current active episode of BV (diagnosis defined as: At least 3 of the 4 Amsel criteria; Nugent score of at least 4; presence of BV-related symptoms)\n* History of recurrent BV (at least 3 episodes in previous year including current episode)\n* Using an effective method of contraception\n\nExclusion Criteria:\n\n* Test positive for a sexually transmitted infection\n* Presence of genital Herpes Simplex Virus (HSV) lesions or Human Papilloma Virus (HPV) lesions requiring treatment\n* Abnormal pelvic exam, including presence of other vaginal or urinary tract infections\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02237950', 'briefTitle': 'Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Starpharma Pty Ltd'}, 'officialTitle': 'A Phase 3, Double-blind, Multicentre, Randomised, Placebo-controlled Study to Determine the Efficacy and Safety of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis', 'orgStudyIdInfo': {'id': 'SPL7013-017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1% SPL7013 Gel', 'description': 'Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks', 'interventionNames': ['Drug: Metronidazole oral tablets 500mg', 'Drug: 1% SPL7013 Gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Gel', 'description': 'Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks', 'interventionNames': ['Drug: Metronidazole oral tablets 500mg', 'Drug: Placebo gel']}], 'interventions': [{'name': 'Metronidazole oral tablets 500mg', 'type': 'DRUG', 'description': 'One tablet taken orally twice daily for seven consecutive days', 'armGroupLabels': ['1% SPL7013 Gel', 'Placebo Gel']}, {'name': '1% SPL7013 Gel', 'type': 'DRUG', 'otherNames': ['VivaGel', 'astodimer sodium'], 'description': '5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.', 'armGroupLabels': ['1% SPL7013 Gel']}, {'name': 'Placebo gel', 'type': 'DRUG', 'description': '5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks', 'armGroupLabels': ['Placebo Gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36117', 'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'facility': "Montgomery Women's Health Associates", 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Lynn Institute of the Ozarks', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92114', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Precision Research Institute', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Women's Health Care", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Lynn Institute of the Rockies', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80209', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': "Downtown Women's Health Care", 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'The Community Research South Florida', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33142', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Medical Center and Research Inc.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Institute of South Florida', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33141', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Community Medical Research', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '33409', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Comprehensive Clinical Trials', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30041', 'city': 'Alpharetta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Medical Research Institute', 'geoPoint': {'lat': 34.07538, 'lon': -84.29409}}, {'zip': '30067', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Urban Family Practice Associates', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '67114', 'city': 'Newton', 'state': 'Kansas', 'country': 'United States', 'facility': 'Heartland Research Associates, LLC', 'geoPoint': {'lat': 38.04668, 'lon': -97.34504}}, {'zip': '49079', 'city': 'Paw Paw', 'state': 'Michigan', 'country': 'United States', 'facility': "Women's Healthcare Specialists", 'geoPoint': {'lat': 42.21782, 'lon': -85.89112}}, {'zip': '68510', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': "Women's Clinic of Lincoln, PC", 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '68154', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Alegent Creighton Health', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89105', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Affiliated Clinical Research', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08648', 'city': 'Lawrenceville', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Lawrence OB-GYN Associates', 'geoPoint': {'lat': 40.29733, 'lon': -74.7296}}, {'zip': '27518', 'city': 'Cary', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Cary, LLC', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}, {'zip': '28144', 'city': 'Salisbury', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Salisbury', 'geoPoint': {'lat': 35.67097, 'lon': -80.47423}}, {'zip': '44311', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Radiant Research', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '43212', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Radiant Research', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73069', 'city': 'Norman', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Lynn Institute of Norman', 'geoPoint': {'lat': 35.22257, 'lon': -97.43948}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Lynn Health Science Institute', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19114', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Clinical Research of Philadelphia', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29621', 'city': 'Anderson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Clinical Research Advantage', 'geoPoint': {'lat': 34.50344, 'lon': -82.65013}}, {'zip': '49425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Chattanooga Medical Research', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Volunteer Research Group', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "Women's Physician Group", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Practice Research Organization', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Radiant Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84088', 'city': 'South Jordan', 'state': 'Utah', 'country': 'United States', 'facility': 'Jordan River Family Medicine', 'geoPoint': {'lat': 40.56217, 'lon': -111.92966}}, {'zip': '23225', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Clinical Trials of Virginia', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Women's Clinical Research Center", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'N2G1H6', 'city': 'Kitchener', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Medicine Professional Corporation', 'geoPoint': {'lat': 43.42537, 'lon': -80.5112}}, {'zip': 'L3Y5G8', 'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'facility': 'SKDS Research Inc', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'N955C6', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Healthy Image Centre', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'zip': 'H4N3C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'DIEX Recherche Montreal Inc', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'J1H1Z1', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'DIEX Recherche Sherbrooke Inc.', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': '00917', 'city': 'Hato Rey', 'country': 'Puerto Rico', 'facility': 'Torre Auxillo Mutuo'}, {'zip': '00918', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Latin Clinical Trial Center', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'University of Puerto Rico', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Jeremy Paull, PhD.', 'role': 'STUDY_CHAIR', 'affiliation': 'Starpharma Pty Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Starpharma Pty Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}