Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
Study NCT ID:
NCT00694928
Status:
COMPLETED
Last Update Posted:
2012-03-05
First Post:
2008-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vaginal Infection Study 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014627', 'term': 'Vaginitis'}], 'ancestors': [{'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': 'C007084', 'term': 'clindamycin phosphate'}, {'id': 'C017125', 'term': 'butoconazole'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 843}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'dispFirstSubmitDate': '2010-11-02', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-29', 'studyFirstSubmitDate': '2008-06-09', 'dispFirstSubmitQcDate': '2011-01-27', 'studyFirstSubmitQcDate': '2008-06-10', 'dispFirstPostDateStruct': {'date': '2011-01-31', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical symptom resolution', 'timeFrame': 'baseline, 7 to 10 days and 21 to 30 days'}], 'secondaryOutcomes': [{'measure': 'Yeast Culture for Candida', 'timeFrame': 'baseline, 7 to 10 days and 21 to 30 days', 'description': 'Negative Yeast Culture for Candida result=response, Positive Yeast Culture for Candida result=no response'}, {'measure': 'Gram Stain Nugent Score', 'timeFrame': 'baseline, 7 to 10 days and 21 to 30 days', 'description': 'Gram stain Nugent score of less than 4= resolution, Gram stain Nugent score of greater than 4= no resolution'}, {'measure': 'Saline wet mount for clue cells', 'timeFrame': 'baseline, 7 to 10 days and 21 to 30 days', 'description': 'Saline wet mount negative for clue cells=resolution, Saline wet mount positive for clue cells=no resolution'}]}, 'conditionsModule': {'conditions': ['Vaginal Infection']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of a vaginal product compared with that of another vaginal product in the treatment of vaginal infections.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have a clinical diagnosis of vaginal infection.\n* Patients must be post-menopausal, surgically sterilized or using an acceptable form of birth control.\n\nExclusion Criteria:\n\n* Patients must not have any other infections\n* May not be pregnant or nursing\n* May not be receiving any other antimicrobial therapies or any medications that would interfere with the outcome of the study.'}, 'identificationModule': {'nctId': 'NCT00694928', 'briefTitle': 'Vaginal Infection Study 2', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lumara Health, Inc.'}, 'orgStudyIdInfo': {'id': 'CBC-303-603-622467'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'clindamycin phosphate/butoconazole nitrate', 'interventionNames': ['Drug: clindamycin phosphate/butoconazole nitrate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'butoconazole nitrate', 'interventionNames': ['Drug: butoconazole nitrate']}], 'interventions': [{'name': 'clindamycin phosphate/butoconazole nitrate', 'type': 'DRUG', 'description': 'semi-solid, single dose', 'armGroupLabels': ['1']}, {'name': 'butoconazole nitrate', 'type': 'DRUG', 'description': 'semi-solid, single dose', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': "Brookwood Ob-GYN, PC/Women's Medical Plaza", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36106', 'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'facility': 'Drug Research Analysis Corp', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'zip': '36106', 'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'facility': 'Drug Research and Analysis Corp.', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Ob/Gyn Associates', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "The Woman's Clinic, PA", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Peak Health Medical Group', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '30035', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Women's Health Care at Frost Street", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '91307', 'city': 'West Hills', 'state': 'California', 'country': 'United States', 'facility': 'Steven Freedman, MD, Inc.', 'geoPoint': {'lat': 34.19731, 'lon': -118.64398}}, {'zip': '80228', 'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Red Rocks OB/GYN', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '06105', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'SHE Medical Center', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '33774', 'city': 'Largo', 'state': 'Florida', 'country': 'United States', 'facility': 'Debra Hemsath, MD', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'zip': '33156', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'International Research Associates', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34684', 'city': 'Palm Harbor', 'state': 'Florida', 'country': 'United States', 'facility': 'Suncoast Clinical Research', 'geoPoint': {'lat': 28.07807, 'lon': -82.76371}}, {'zip': '33024', 'city': 'Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'University Clinical Research'}, {'zip': '30030', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': "Total Women's Health and Wellness", 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '30035', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Dekalb Gynecology Associates', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '30274', 'city': 'Riverdale', 'state': 'Georgia', 'country': 'United States', 'facility': 'New Millennium Ob/Gyn', 'geoPoint': {'lat': 33.57261, 'lon': -84.41326}}, {'zip': '83712', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': "The Woman's Clinic", 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '50266', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'The Iowa Clinic Department of Ob/Gyn', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '21014', 'city': 'Bel Air', 'state': 'Maryland', 'country': 'United States', 'facility': 'Steven Z. Lenowitz, MD, LLC', 'geoPoint': {'lat': 39.53594, 'lon': -76.34829}}, {'zip': '08648', 'city': 'Lawrenceville', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Lawrence Ob/Gyn Associates', 'geoPoint': {'lat': 40.29733, 'lon': -74.7296}}, {'zip': '08648', 'city': 'Lawrenceville', 'state': 'New Jersey', 'country': 'United States', 'facility': "Women's Health Research Center, LLC", 'geoPoint': {'lat': 40.29733, 'lon': -74.7296}}, {'zip': '27518', 'city': 'Cary', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Triangle Ob/Gyn', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}, {'zip': '28304', 'city': 'Fayetteville', 'state': 'North Carolina', 'country': 'United States', 'facility': "Women's Wellness Center", 'geoPoint': {'lat': 35.05266, 'lon': -78.87836}}, {'zip': '27455', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Meridian Clinical Research, LLC', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '45631', 'city': 'Gallipolis', 'state': 'Ohio', 'country': 'United States', 'facility': 'Holzer Clinic', 'geoPoint': {'lat': 38.8098, 'lon': -82.20237}}, {'zip': '44281', 'city': 'Wadsworth', 'state': 'Ohio', 'country': 'United States', 'facility': 'Family Practice Center of Wadsworth, Inc', 'geoPoint': {'lat': 41.02561, 'lon': -81.72985}}, {'zip': '73069', 'city': 'Norman', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Lynn Institute of Norman', 'geoPoint': {'lat': 35.22257, 'lon': -97.43948}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': "Pacific Women's Center, LLC/Clinical Trials of America", 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '19446', 'city': 'Lansdale', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Center for Women's Health of Lansdale", 'geoPoint': {'lat': 40.2415, 'lon': -75.28379}}, {'zip': '29414', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': "Creekside Women's Care", 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29325', 'city': 'Clinton', 'state': 'South Carolina', 'country': 'United States', 'facility': 'The Family Healthcare Center, PA', 'geoPoint': {'lat': 34.47263, 'lon': -81.88066}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Greenville Pharmaceutical Research', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29406', 'city': 'North Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'James T. Martin, Jr., MD, Ob/Gyn', 'geoPoint': {'lat': 32.85462, 'lon': -79.97481}}, {'zip': '57201', 'city': 'Watertown', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Brown Clinical, PLLP', 'geoPoint': {'lat': 44.89941, 'lon': -97.11507}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Gynecology and Obstetrics', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Mid-South Ob/Gyn', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '76039', 'city': 'Euless', 'state': 'Texas', 'country': 'United States', 'facility': 'Kaner Medical Group, PA', 'geoPoint': {'lat': 32.83707, 'lon': -97.08195}}, {'zip': '78505', 'city': 'McAllen', 'state': 'Texas', 'country': 'United States', 'facility': 'Advanced Reserch Associates', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Willowbend Health & Wellness', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '84010', 'city': 'Bountiful', 'state': 'Utah', 'country': 'United States', 'facility': 'Taylor/Wade Medical', 'geoPoint': {'lat': 40.88939, 'lon': -111.88077}}, {'zip': '05495', 'city': 'Williston', 'state': 'Vermont', 'country': 'United States', 'facility': 'Vermont Urogynecology Associates, PC', 'geoPoint': {'lat': 44.43755, 'lon': -73.06818}}, {'zip': '23456', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'Tidewater Clinical Research', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}, {'zip': '560043', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Bangalore Diabetes Centre', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '575004', 'city': 'Mangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'AJ Medical College and Hospital', 'geoPoint': {'lat': 12.91723, 'lon': 74.85603}}, {'zip': '305001', 'city': 'Ajmer', 'state': 'Rajasthan', 'country': 'India', 'facility': 'Mayani Hosptial and Research Centre', 'geoPoint': {'lat': 26.4521, 'lon': 74.63867}}, {'zip': '302020', 'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'Sharda Hospital', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'zip': '226003', 'city': 'Lucknow', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'MV Hospital and Research Centre', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}, {'zip': '500034', 'city': 'Hyderabad', 'country': 'India', 'facility': 'Care Hospital', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'zip': '302001', 'city': 'Jaipur', 'country': 'India', 'facility': 'Shri Krishna Hospital', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'zip': '501401', 'city': 'Ranga Reddy District', 'country': 'India', 'facility': 'Mediciti Institute of Medical Sciences'}, {'zip': '500003', 'city': 'Secunderabad', 'country': 'India', 'facility': 'Krishna Institute of Medical Sciences', 'geoPoint': {'lat': 17.50427, 'lon': 78.54263}}, {'zip': '530002', 'city': 'Visakhapatnam', 'country': 'India', 'facility': 'King George Hospital', 'geoPoint': {'lat': 17.68009, 'lon': 83.20161}}, {'zip': '197706', 'city': 'Sestroretsk', 'state': 'Sankt-Peterburg', 'country': 'Russia', 'facility': 'Kurortniy Ward City Hospital #40', 'geoPoint': {'lat': 60.09801, 'lon': 29.96378}}, {'zip': '420012', 'city': "Kazan'", 'country': 'Russia', 'facility': 'Medical University Clinic', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '350020', 'city': 'Krasnodar', 'country': 'Russia', 'facility': 'Clinical Dermatovenerologic Dispensary', 'geoPoint': {'lat': 45.04534, 'lon': 38.98178}}, {'zip': '107076', 'city': 'Moscow', 'country': 'Russia', 'facility': 'State Dermatovenerology Research Center of the Federal Agency for Provision of High Technology Medical Aid', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '115516', 'city': 'Moscow', 'country': 'Russia', 'facility': 'State Health Care Institution Moscow City Clinical Hospital #12', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '123995', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Russian Medical Academy of Postgraduate Studies of Roszdrav', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '127473', 'city': 'Moscow', 'country': 'Russia', 'facility': 'State Healthcare Institution Moscow Clinical Hospital #68', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '630082', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Novisibirsk Municipal Dermatovenerologic Dispensary #1', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'zip': '460000', 'city': 'Orenburg', 'country': 'Russia', 'facility': 'State Health Care Institution Orenburg Regional Clinical Hospital #2', 'geoPoint': {'lat': 51.76712, 'lon': 55.09883}}, {'zip': '185002', 'city': 'Petrozavodsk', 'country': 'Russia', 'facility': 'Republican Dermatovenerologic Dispensary, MoH of Karelia Republic', 'geoPoint': {'lat': 61.78491, 'lon': 34.34691}}, {'zip': '190000', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Maximillian City Hospital #28', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '190020', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'State Healthcare Institution Regional Dermatovenerologic Dispensary', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '194044', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'S.M. Kirov Military Medical Academy, MoD of the Russian Federation', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '194354', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'City Multifield Hospital', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '196084', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Medical Research Institute, LLC', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '196247', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'City Hospital #26', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197022', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'St. Petersburg I.P. Pavlov State Medical University of Roszdrav', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '394024', 'city': 'Voronezh', 'country': 'Russia', 'facility': 'Railway Clinic Hospital of the Voronezh-,1 Railway Station, RJD JSC', 'geoPoint': {'lat': 51.66833, 'lon': 39.19204}}, {'zip': '394038', 'city': 'Voronezh', 'country': 'Russia', 'facility': 'Voronezh Regional Clinical Dermatovenerologic Dispensary', 'geoPoint': {'lat': 51.66833, 'lon': 39.19204}}, {'zip': '150003', 'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'Yaroslavl Regional Maternity Hospital', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}], 'overallOfficials': [{'name': 'Jim Joffrion', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lumara Health, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lumara Health, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}