Vaginal Infection Study 2
- Conditions
- Vaginal Infection
- Interventions
- Registration Number
- NCT00694928
- Lead Sponsor
- Lumara Health, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 843
- Patients must have a clinical diagnosis of vaginal infection.
- Patients must be post-menopausal, surgically sterilized or using an acceptable form of birth control.
- Patients must not have any other infections
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 clindamycin phosphate/butoconazole nitrate clindamycin phosphate/butoconazole nitrate 2 butoconazole nitrate butoconazole nitrate
- Primary Outcome Measures
Name Time Method Clinical symptom resolution baseline, 7 to 10 days and 21 to 30 days
- Secondary Outcome Measures
Name Time Method Yeast Culture for Candida baseline, 7 to 10 days and 21 to 30 days Negative Yeast Culture for Candida result=response, Positive Yeast Culture for Candida result=no response
Gram Stain Nugent Score baseline, 7 to 10 days and 21 to 30 days Gram stain Nugent score of less than 4= resolution, Gram stain Nugent score of greater than 4= no resolution
Saline wet mount for clue cells baseline, 7 to 10 days and 21 to 30 days Saline wet mount negative for clue cells=resolution, Saline wet mount positive for clue cells=no resolution
Trial Locations
- Locations (73)
Ob/Gyn Associates
🇺🇸Jonesboro, Arkansas, United States
Triangle Ob/Gyn
🇺🇸Cary, North Carolina, United States
Tidewater Clinical Research
🇺🇸Virginia Beach, Virginia, United States
Drug Research Analysis Corp
🇺🇸Montgomery, Alabama, United States
Dekalb Gynecology Associates
🇺🇸Decatur, Georgia, United States
Suncoast Clinical Research
🇺🇸Palm Harbor, Florida, United States
Peak Health Medical Group
🇺🇸Los Angeles, California, United States
Debra Hemsath, MD
🇺🇸Largo, Florida, United States
Steven Freedman, MD, Inc.
🇺🇸West Hills, California, United States
Total Women's Health and Wellness
🇺🇸Decatur, Georgia, United States
Drug Research and Analysis Corp.
🇺🇸Montgomery, Alabama, United States
Pacific Women's Center, LLC/Clinical Trials of America
🇺🇸Eugene, Oregon, United States
Taylor/Wade Medical
🇺🇸Bountiful, Utah, United States
Care Hospital
🇮🇳Hyderabad, India
University Clinical Research
🇺🇸Pines, Florida, United States
New Millennium Ob/Gyn
🇺🇸Riverdale, Georgia, United States
The Woman's Clinic
🇺🇸Boise, Idaho, United States
Meridian Clinical Research, LLC
🇺🇸Greensboro, North Carolina, United States
Lynn Institute of Norman
🇺🇸Norman, Oklahoma, United States
Shri Krishna Hospital
🇮🇳Jaipur, India
Family Practice Center of Wadsworth, Inc
🇺🇸Wadsworth, Ohio, United States
The Family Healthcare Center, PA
🇺🇸Clinton, South Carolina, United States
Willowbend Health & Wellness
🇺🇸Plano, Texas, United States
Women's Wellness Center
🇺🇸Fayetteville, North Carolina, United States
Holzer Clinic
🇺🇸Gallipolis, Ohio, United States
Kaner Medical Group, PA
🇺🇸Euless, Texas, United States
Medical University Clinic
🇷🇺Kazan, Russian Federation
Novisibirsk Municipal Dermatovenerologic Dispensary #1
🇷🇺Novosibirsk, Russian Federation
Republican Dermatovenerologic Dispensary, MoH of Karelia Republic
🇷🇺Petrozavodsk, Russian Federation
International Research Associates
🇺🇸Miami, Florida, United States
Women's Health Care at Frost Street
🇺🇸San Diego, California, United States
Mayani Hosptial and Research Centre
🇮🇳Ajmer, Rajasthan, India
Sharda Hospital
🇮🇳Jaipur, Rajasthan, India
State Health Care Institution Moscow City Clinical Hospital #12
🇷🇺Moscow, Russian Federation
State Health Care Institution Orenburg Regional Clinical Hospital #2
🇷🇺Orenburg, Russian Federation
Medical Research Institute, LLC
🇷🇺Saint Petersburg, Russian Federation
Voronezh Regional Clinical Dermatovenerologic Dispensary
🇷🇺Voronezh, Russian Federation
Brookwood Ob-GYN, PC/Women's Medical Plaza
🇺🇸Birmingham, Alabama, United States
Red Rocks OB/GYN
🇺🇸Lakewood, Colorado, United States
Mid-South Ob/Gyn
🇺🇸Memphis, Tennessee, United States
Steven Z. Lenowitz, MD, LLC
🇺🇸Bel Air, Maryland, United States
Creekside Women's Care
🇺🇸Charleston, South Carolina, United States
Advanced Reserch Associates
🇺🇸McAllen, Texas, United States
Krishna Institute of Medical Sciences
🇮🇳Secunderabad, India
Russian Medical Academy of Postgraduate Studies of Roszdrav
🇷🇺Moscow, Russian Federation
State Healthcare Institution Moscow Clinical Hospital #68
🇷🇺Moscow, Russian Federation
City Multifield Hospital
🇷🇺Saint Petersburg, Russian Federation
AJ Medical College and Hospital
🇮🇳Mangalore, Karnataka, India
Mediciti Institute of Medical Sciences
🇮🇳Ranga Reddy District, India
SHE Medical Center
🇺🇸Hartford, Connecticut, United States
Bangalore Diabetes Centre
🇮🇳Bangalore, Karnataka, India
St. Petersburg I.P. Pavlov State Medical University of Roszdrav
🇷🇺Saint Petersburg, Russian Federation
Railway Clinic Hospital of the Voronezh-,1 Railway Station, RJD JSC
🇷🇺Voronezh, Russian Federation
Gynecology and Obstetrics
🇺🇸Memphis, Tennessee, United States
MV Hospital and Research Centre
🇮🇳Lucknow, Uttar Pradesh, India
Clinical Dermatovenerologic Dispensary
🇷🇺Krasnodar, Russian Federation
Brown Clinical, PLLP
🇺🇸Watertown, South Dakota, United States
State Dermatovenerology Research Center of the Federal Agency for Provision of High Technology Medical Aid
🇷🇺Moscow, Russian Federation
James T. Martin, Jr., MD, Ob/Gyn
🇺🇸North Charleston, South Carolina, United States
Kurortniy Ward City Hospital #40
🇷🇺Sestroretsk, Saint Petersburg, Russian Federation
State Healthcare Institution Regional Dermatovenerologic Dispensary
🇷🇺Saint Petersburg, Russian Federation
City Hospital #26
🇷🇺Saint Petersburg, Russian Federation
Yaroslavl Regional Maternity Hospital
🇷🇺Yaroslavl, Russian Federation
The Woman's Clinic, PA
🇺🇸Little Rock, Arkansas, United States
Vermont Urogynecology Associates, PC
🇺🇸Williston, Vermont, United States
King George Hospital
🇮🇳Visakhapatnam, India
Maximillian City Hospital #28
🇷🇺Saint Petersburg, Russian Federation
S.M. Kirov Military Medical Academy, MoD of the Russian Federation
🇷🇺Saint Petersburg, Russian Federation
Lawrence Ob/Gyn Associates
🇺🇸Lawrenceville, New Jersey, United States
Women's Health Research Center, LLC
🇺🇸Lawrenceville, New Jersey, United States
Greenville Pharmaceutical Research
🇺🇸Greenville, South Carolina, United States
The Iowa Clinic Department of Ob/Gyn
🇺🇸West Des Moines, Iowa, United States
Center for Women's Health of Lansdale
🇺🇸Lansdale, Pennsylvania, United States