Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
843 participants
INTERVENTIONAL
2008-05-31
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
clindamycin phosphate/butoconazole nitrate
clindamycin phosphate/butoconazole nitrate
semi-solid, single dose
2
butoconazole nitrate
butoconazole nitrate
semi-solid, single dose
Interventions
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clindamycin phosphate/butoconazole nitrate
semi-solid, single dose
butoconazole nitrate
semi-solid, single dose
Eligibility Criteria
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Inclusion Criteria
* Patients must be post-menopausal, surgically sterilized or using an acceptable form of birth control.
Exclusion Criteria
* May not be pregnant or nursing
* May not be receiving any other antimicrobial therapies or any medications that would interfere with the outcome of the study.
16 Years
FEMALE
No
Sponsors
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Lumara Health, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jim Joffrion
Role: STUDY_DIRECTOR
Lumara Health, Inc.
Locations
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Brookwood Ob-GYN, PC/Women's Medical Plaza
Birmingham, Alabama, United States
Drug Research Analysis Corp
Montgomery, Alabama, United States
Drug Research and Analysis Corp.
Montgomery, Alabama, United States
Ob/Gyn Associates
Jonesboro, Arkansas, United States
The Woman's Clinic, PA
Little Rock, Arkansas, United States
Peak Health Medical Group
Los Angeles, California, United States
Women's Health Care at Frost Street
San Diego, California, United States
Steven Freedman, MD, Inc.
West Hills, California, United States
Red Rocks OB/GYN
Lakewood, Colorado, United States
SHE Medical Center
Hartford, Connecticut, United States
Debra Hemsath, MD
Largo, Florida, United States
International Research Associates
Miami, Florida, United States
Suncoast Clinical Research
Palm Harbor, Florida, United States
University Clinical Research
Pines, Florida, United States
Total Women's Health and Wellness
Decatur, Georgia, United States
Dekalb Gynecology Associates
Decatur, Georgia, United States
New Millennium Ob/Gyn
Riverdale, Georgia, United States
The Woman's Clinic
Boise, Idaho, United States
The Iowa Clinic Department of Ob/Gyn
West Des Moines, Iowa, United States
Steven Z. Lenowitz, MD, LLC
Bel Air, Maryland, United States
Lawrence Ob/Gyn Associates
Lawrenceville, New Jersey, United States
Women's Health Research Center, LLC
Lawrenceville, New Jersey, United States
Triangle Ob/Gyn
Cary, North Carolina, United States
Women's Wellness Center
Fayetteville, North Carolina, United States
Meridian Clinical Research, LLC
Greensboro, North Carolina, United States
Holzer Clinic
Gallipolis, Ohio, United States
Family Practice Center of Wadsworth, Inc
Wadsworth, Ohio, United States
Lynn Institute of Norman
Norman, Oklahoma, United States
Pacific Women's Center, LLC/Clinical Trials of America
Eugene, Oregon, United States
Center for Women's Health of Lansdale
Lansdale, Pennsylvania, United States
Creekside Women's Care
Charleston, South Carolina, United States
The Family Healthcare Center, PA
Clinton, South Carolina, United States
Greenville Pharmaceutical Research
Greenville, South Carolina, United States
James T. Martin, Jr., MD, Ob/Gyn
North Charleston, South Carolina, United States
Brown Clinical, PLLP
Watertown, South Dakota, United States
Gynecology and Obstetrics
Memphis, Tennessee, United States
Mid-South Ob/Gyn
Memphis, Tennessee, United States
Kaner Medical Group, PA
Euless, Texas, United States
Advanced Reserch Associates
McAllen, Texas, United States
Willowbend Health & Wellness
Plano, Texas, United States
Taylor/Wade Medical
Bountiful, Utah, United States
Vermont Urogynecology Associates, PC
Williston, Vermont, United States
Tidewater Clinical Research
Virginia Beach, Virginia, United States
Bangalore Diabetes Centre
Bangalore, Karnataka, India
AJ Medical College and Hospital
Mangalore, Karnataka, India
Mayani Hosptial and Research Centre
Ajmer, Rajasthan, India
Sharda Hospital
Jaipur, Rajasthan, India
MV Hospital and Research Centre
Lucknow, Uttar Pradesh, India
Care Hospital
Hyderabad, , India
Shri Krishna Hospital
Jaipur, , India
Mediciti Institute of Medical Sciences
Ranga Reddy District, , India
Krishna Institute of Medical Sciences
Secunderabad, , India
King George Hospital
Visakhapatnam, , India
Kurortniy Ward City Hospital #40
Sestroretsk, Sankt-Peterburg, Russia
Medical University Clinic
Kazan', , Russia
Clinical Dermatovenerologic Dispensary
Krasnodar, , Russia
State Dermatovenerology Research Center of the Federal Agency for Provision of High Technology Medical Aid
Moscow, , Russia
State Health Care Institution Moscow City Clinical Hospital #12
Moscow, , Russia
Russian Medical Academy of Postgraduate Studies of Roszdrav
Moscow, , Russia
State Healthcare Institution Moscow Clinical Hospital #68
Moscow, , Russia
Novisibirsk Municipal Dermatovenerologic Dispensary #1
Novosibirsk, , Russia
State Health Care Institution Orenburg Regional Clinical Hospital #2
Orenburg, , Russia
Republican Dermatovenerologic Dispensary, MoH of Karelia Republic
Petrozavodsk, , Russia
Maximillian City Hospital #28
Saint Petersburg, , Russia
State Healthcare Institution Regional Dermatovenerologic Dispensary
Saint Petersburg, , Russia
S.M. Kirov Military Medical Academy, MoD of the Russian Federation
Saint Petersburg, , Russia
City Multifield Hospital
Saint Petersburg, , Russia
Medical Research Institute, LLC
Saint Petersburg, , Russia
City Hospital #26
Saint Petersburg, , Russia
St. Petersburg I.P. Pavlov State Medical University of Roszdrav
Saint Petersburg, , Russia
Railway Clinic Hospital of the Voronezh-,1 Railway Station, RJD JSC
Voronezh, , Russia
Voronezh Regional Clinical Dermatovenerologic Dispensary
Voronezh, , Russia
Yaroslavl Regional Maternity Hospital
Yaroslavl, , Russia
Countries
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Other Identifiers
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CBC-303-603-622467
Identifier Type: -
Identifier Source: org_study_id
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