Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-02-20 @ 6:40 PM
Study NCT ID:
NCT02236156
Status:
COMPLETED
Last Update Posted:
2018-06-25
First Post:
2014-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, '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': 637}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'dispFirstSubmitDate': '2017-12-04', 'completionDateStruct': {'date': '2016-10-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-21', 'studyFirstSubmitDate': '2014-09-05', 'dispFirstSubmitQcDate': '2017-12-04', 'studyFirstSubmitQcDate': '2014-09-08', 'dispFirstPostDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07-04', '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'}], 'secondaryOutcomes': [{'measure': 'Time to recurrence of BV according to the primary efficacy endpoint definition', 'timeFrame': 'At or by the Week 28 visit', 'description': 'Time (days)'}, {'measure': 'Presence of patient-reported BV symptoms', 'timeFrame': 'At or by the Week 16 visit', 'description': 'Number of participants with symptoms'}, {'measure': 'Recurrence of individual Amsel criteria', 'timeFrame': 'At or by the Week 16 visit', 'description': 'Individual Amsel criteria are:\n\ni) Presence of homogenous vaginal discharge characteristic of BV\n\nii) Positive whiff test\n\niii) Clue cells representing at least 20% of total epithelial cells\n\niv) vaginal fluid pH greater than 4.5'}, {'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'}, {'measure': 'Recurrence of BV according to the primary efficacy endpoint definition', 'timeFrame': 'At or by the Week 20, 24 and 28 visits', 'description': 'Number of participants with a recurrence'}, {'measure': 'Recurrence of BV according to the composite definition of at least 3 clinical findings and a Nugent score of at least 4', 'timeFrame': 'At or by the Week 16 visit', 'description': 'Number of participants with a recurrence'}, {'measure': 'Adverse events (AEs)', 'timeFrame': 'Study duration', 'description': 'Number of participants'}, {'measure': 'Responses to Quality of Life (QoL) Questionnaires', 'timeFrame': 'Screening to Week 16'}]}, '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': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current active episode of BV (diagnosis defined as: at least 3 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': 'NCT02236156', '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': 'SPL7013-018'}}, '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': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Precision Trials, LLC', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Medical Center for Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '70001', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Southern Clinical Research Associates', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Lyndhurst Clinical Research', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'Sites Various', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'city': 'Plovidiv', 'country': 'Bulgaria', 'facility': 'Sites Various'}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Sites Various', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Stara Zagora', 'country': 'Bulgaria', 'facility': 'Sites Various', 'geoPoint': {'lat': 42.43205, 'lon': 25.64262}}, {'city': 'Brno', 'country': 'Czechia', 'facility': 'Sites Various', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'České Budějovice', 'country': 'Czechia', 'facility': 'Sites Various', 'geoPoint': {'lat': 48.97447, 'lon': 14.47434}}, {'city': 'Olomouc', 'country': 'Czechia', 'facility': 'Sites Various', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'city': 'Písek', 'country': 'Czechia', 'facility': 'Sites Various', 'geoPoint': {'lat': 49.3088, 'lon': 14.1475}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Sites Various', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Vsetín', 'country': 'Czechia', 'facility': 'Sites Various', 'geoPoint': {'lat': 49.33871, 'lon': 17.99619}}, {'city': 'Baja', 'country': 'Hungary', 'facility': 'Sites Various', 'geoPoint': {'lat': 46.18299, 'lon': 18.95307}}, {'city': 'Balatonfüred', 'country': 'Hungary', 'facility': 'Sites Various', 'geoPoint': {'lat': 46.96188, 'lon': 17.87187}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Sites Various', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Sites Various', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'city': 'Gyömrő', 'country': 'Hungary', 'facility': 'Sites Various', 'geoPoint': {'lat': 47.42733, 'lon': 19.40133}}, {'city': 'Komárom', 'country': 'Hungary', 'facility': 'Sites Various', 'geoPoint': {'lat': 47.74318, 'lon': 18.11913}}, {'city': 'Létavértes', 'country': 'Hungary', 'facility': 'Sites Various', 'geoPoint': {'lat': 47.38333, 'lon': 21.9}}, {'city': 'Zalaegerszeg', 'country': 'Hungary', 'facility': 'Sites Various', 'geoPoint': {'lat': 46.83695, 'lon': 16.84401}}, {'city': 'Ivano-Frankivsk', 'country': 'Ukraine', 'facility': 'Sites Various', 'geoPoint': {'lat': 48.92312, 'lon': 24.71248}}, {'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Sites Various', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'city': 'Zaporizhzhia', 'country': 'Ukraine', 'facility': 'Sites Various', 'geoPoint': {'lat': 47.15214, 'lon': 35.74246}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Sites Various', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Coventry', 'country': 'United Kingdom', 'facility': 'Sites Various', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Sites Various', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Sites Various', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'Sites Various', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}], 'overallOfficials': [{'name': 'Jeremy Paull, PhD.', 'role': 'STUDY_CHAIR', 'affiliation': 'Starpharma Pty Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Starpharma Pty Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}