Vaginal Infection Study
- Conditions
- VulvovaginitisVaginitis
- Interventions
- Registration Number
- NCT00616330
- Lead Sponsor
- Lumara Health, Inc.
- Brief Summary
This study will evaluate the efficacy and safety of a vaginal product compared with that of other vaginal products in the treatment of vaginal infections.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1443
- 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 3 butoconazole nitrate butoconazole nitrate 2 clindamycin phosphate clindamycin phosphate
- 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 (130)
Northern Indiana Womens Health Research
🇺🇸South Bend, Indiana, United States
Comprehensive Clinical Trials, LLC
🇺🇸West Palm Beach, Florida, United States
Medford Women's Clinic, LLP
🇺🇸Medford, Oregon, United States
New England Center for Clinical Research, Inc.
🇺🇸Fall River, Massachusetts, United States
Women's Health Partner
🇺🇸St. Louis, Missouri, United States
Hyperion Clinical Research, LLC
🇺🇸Charleston, West Virginia, United States
KEM Hospital Research Centre
🇮🇳Pune, Maharashtra, India
Deenanath Mangeshkar Hospital and Research Centre
🇮🇳Pune, Maharashtra, India
The Woman's Hospital of Texas Clinical Research Center
🇺🇸Houston, Texas, United States
InVisions Consultants, LLC c/o Northeast Ob/Gyn
🇺🇸San Antonio, Texas, United States
Women's Health Research
🇺🇸Phoenix, Arizona, United States
Salt Lake Research
🇺🇸Salt Lake City, Utah, United States
Universal Biopharma Research Institute, Inc./Alta Family Health Clinic, Inc.
🇺🇸Dinuba, California, United States
Lynn Institute of Pueblo
🇺🇸Pueblo, Colorado, United States
Choice Research, LLC
🇺🇸Enterprise, Alabama, United States
Soapstone Center for Clinical Research
🇺🇸Decatur, Georgia, United States
Women's Health Care Specialists, PC
🇺🇸Paw Paw, Michigan, United States
Med Center
🇺🇸Carmichael, California, United States
AMR Research Associates
🇺🇸Bogart, Georgia, United States
Sierra Medical Research
🇺🇸Fresno, California, United States
Women's Medical Research Group, LLC
🇺🇸Clearwater, Florida, United States
Hawthorne Medical Research, Inc.
🇺🇸Winston-Salem, North Carolina, United States
Women Partners in Health
🇺🇸Austin, Texas, United States
Female Pelvic Medicine and Urogynecology Institute of Michigan
🇺🇸Grand Rapids, Michigan, United States
Suffolk Ob/Gyn
🇺🇸Port Jefferson, New York, United States
Physician Care Clinical Research
🇺🇸Sarasota, Florida, United States
Consultants in Women's Healthcare
🇺🇸St. Louis, Missouri, United States
Eastern Carolina Women's Center
🇺🇸New Bern, North Carolina, United States
Insignia Clinical Research
🇺🇸Tampa, Florida, United States
Valaores & Lewis Obstetrics & Gynocology
🇺🇸Winston-Salem, North Carolina, United States
Red Rocks OB/GYN
🇺🇸Lakewood, Colorado, United States
Segal Institute for Clinical Research
🇺🇸North Miami, Florida, United States
Preferred OB/GYN/ Women's Health
🇺🇸Woodbury, New York, United States
Lynn Institute of the Rockies
🇺🇸Colorado Springs, Colorado, United States
Regional Research Specialists, LLC
🇺🇸Shreveport, Louisiana, United States
Activmed Practices & Research, Inc.
🇺🇸Haverhill, Massachusetts, United States
Tidewater Clinical Research, Inc
🇺🇸Virginia Beach, Virginia, United States
Eastowne OB-GYN and Infertility
🇺🇸Chapel Hill, North Carolina, United States
King's Daughter Clinic
🇺🇸Temple, Texas, United States
Holzer Clinic
🇺🇸Gallipolis, Ohio, United States
The Medical Group of Northern Nevada
🇺🇸Reno, Nevada, United States
Complete Healthcare for Women
🇺🇸Columbus, Ohio, United States
Mt. Timpangos Women's Healthcare
🇺🇸Pleasant Grove, Utah, United States
Clinical Research Consultants, Inc
🇺🇸Birmingham, Alabama, United States
Aurora Advanced Healthcare, Inc
🇺🇸Milwaukee, Wisconsin, United States
The Woman's Clinic, P.A.
🇺🇸Little Rock, Arkansas, United States
Women's Health Care Associates, PC
🇺🇸Hartford, Connecticut, United States
Precision Trials LLC
🇺🇸Phoenix, Arizona, United States
Jefferson Clinic, PC
🇺🇸Birmingham, Alabama, United States
Grossmont Center for Clinical Research
🇺🇸La Mesa, California, United States
San Diego Clinical Research Center
🇺🇸San Diego, California, United States
Medical Network for Educators and Research
🇺🇸Decatur, Georgia, United States
Pacific Women's Center, LLC
🇺🇸Eugene, Oregon, United States
Research Across America
🇺🇸El Paso, Texas, United States
HWC Women's Research Center
🇺🇸Englewood, Ohio, United States
Visions Clinical Research - Tucson
🇺🇸Tucson, Arizona, United States
Planned Parenthood of Houston
🇺🇸Houston, Texas, United States
Walla Walla Clinic
🇺🇸Walla Walla, Washington, United States
Atlanta Medical Research Institute
🇺🇸Alpharetta, Georgia, United States
Atlanta West Women's Center
🇺🇸Douglasville, Georgia, United States
Womans Health Practice, LLC
🇺🇸Champaign, Illinois, United States
Healthcare for Women
🇺🇸New Bedford, Massachusetts, United States
New Ballas OB-GYN, Inc.
🇺🇸St. Louis, Missouri, United States
Mid Dakota Clinic Center for Women
🇺🇸Bismark, North Dakota, United States
Laurel Highlands Ob/Gyn, PC
🇺🇸Hopwood, Pennsylvania, United States
Clinical Trials Research Services, LLC
🇺🇸Natrona Heights, Pennsylvania, United States
Women's Care Center, PLC
🇺🇸Memphis, Tennessee, United States
Advanced Research Associates
🇺🇸Corpus Christi, Texas, United States
TMC Life Research, Inc
🇺🇸Houston, Texas, United States
Tanner Clinic
🇺🇸Layton, Utah, United States
Bexar Clinical Trials, LLC
🇺🇸Irving, Texas, United States
Willowbend Health and Wellness
🇺🇸Plano, Texas, United States
Krishna Hospital Surgical & Maternity 201/2/3 Suryadeep Complex
🇮🇳Vadodara, Gujarat, India
Salt Lake Women's Center
🇺🇸Sandy, Utah, United States
Father Muller Medical College Hospital
🇮🇳Mangalore, Kamataka, India
Om Women's Hospital
🇮🇳Nagpur, Maharashtra, India
Nagpur Test Tube Baby Centre
🇮🇳Nagpur, Maharashtra, India
VSG Healthcare, Dr. Ganorkar Hospital
🇮🇳Nashik, Maharashtra, India
Sri Ramachandra Medical College
🇮🇳Tamil Nadu, India
Yashoda Super Speciality Hospital
🇮🇳Ghaziabad, India
M.K.W. Hospital and Research Centre
🇮🇳New Delhi, India
D.O. Ott Research Institute of Ob/Gyn--Gynecologic Endocrinology
🇷🇺Mendeleyevskaya, Saint Petersburg, Russian Federation
D.O. Ott Research Institute of Ob/Gyn--Family Planning and Female Health Center
🇷🇺Mendeleevskaya line, Saint Petersburg, Russian Federation
Dermatovenerologic Dispensary
🇷🇺Korolev, Moscow Region, Russian Federation
Orkli, LLC
🇷🇺V.o., Saint Petersburg, Russian Federation
Smolensk State Medical Academy of Roszdrav
🇷🇺Smolensk, Smolensk Region, Russian Federation
Kaluga Regional Dermatovenerologic Dispensary
🇷🇺Kaluga, Russian Federation
Dermatovenerologic Dispensary #15
🇷🇺Moscow, Russian Federation
Moscow Regional Research Insitute of Obstetrics and Gynecology
🇷🇺Moscow, Russian Federation
City Clinical Hospital #52
🇷🇺Moscow, Russian Federation
City Clinical Hospital #31
🇷🇺Moscow, Russian Federation
Clinic of Skin and Sexual Transmitted Diseases
🇷🇺Moscow, Russian Federation
Regional Dermatovenerologic Dispensary
🇷🇺Rostov-on-Don, Russian Federation
Ryazan Regional Clinical Dermatovenerologic Dispensary
🇷🇺Ryazan, Russian Federation
442 District Military Clinical Hospital of Leningradsky Military District
🇷🇺Saint Petersburg, Russian Federation
L.G. Sokolov Clinical Hospital #122 of the Federal Medical-Biologic Agency--#322
🇷🇺Saint Petersburg, Russian Federation
L.G. Sokolov Clinical Hospital #122 of the Federal Medical-Biologic Agency--#321
🇷🇺Saint Petersburg, Russian Federation
Leningradskiy Regional Clinical Hospital
🇷🇺Saint Petersburg, Russian Federation
Star W. Research
🇺🇸Chandler, Arizona, United States
The Woman's Clinic
🇺🇸Boise, Idaho, United States
Precision Clinical Research
🇺🇸Searcy, Arkansas, United States
NEA Women's Clinic
🇺🇸Jonesboro, Arkansas, United States
KMC Hospital
🇮🇳Mangalore, Karnataka, India
Chopra Nursing and Maternity Home
🇮🇳Agra, India
Government Maternity Hospital
🇮🇳Hyderabad, India
St. Petersburg State I.I. Mechnikov Medical Academy of Roszdrav
🇷🇺Saint Petersburg, Russian Federation
Smolensk Dermatovenerologic Dispensary
🇷🇺Smolensk, Russian Federation
Dr. D. Y. Patil Medical College & Hospital
🇮🇳Pune, Maharashtra, India
Greater Hartford Womens Association/Women's Health
🇺🇸West Hartford, Connecticut, United States
Rosemark Women Care Specialists
🇺🇸Idaho Falls, Idaho, United States
Makker Medical Center
🇮🇳Lucknow, India
Juventa--Reproductive Health
🇷🇺Saint Petersburg, Russian Federation
Clinical Trials Management
🇺🇸Mandeville, Louisiana, United States
The Peoples' Friendship University of Russia
🇷🇺Moscow, Russian Federation
Neha Prakash Hospital
🇮🇳Bangalore, Karnataka, India
Yenepoya Medical College and Hospital
🇮🇳Mangalore, Karnataka, India
City Dermatovenerologic Dispensary
🇷🇺Saint Petersburg, Russian Federation
Andros Clinic, LLC
🇷🇺Saint Petersburg, Russian Federation
Arkansas Primary Care Clinic, PA
🇺🇸Little Rock, Arkansas, United States
Institute of Kidney Disease and Research Centre
🇮🇳Ahmedabad, Gujarat, India
Avanti Institute of Cardiology
🇮🇳Nagpur, Maharashtra, India
City Clinical Hospital #51
🇷🇺Moscow, Russian Federation
Ponce School of Medicine
🇵🇷Ponce, Puerto Rico
Family Planning and Reproductive Centre
🇷🇺Saint Petersburg, Russian Federation
S.M. Kirov Military Medical Academy, MoD of the Russian Federation
🇷🇺Saint Petersburg, Russian Federation
Nivedita Hospital
🇮🇳Nashik, Maharashtra, India
Nizhegorodskiy Dermatovenerologic Scientific Research Institute of Federal Agency for Public Health and Human Services
🇷🇺Nizhny Novgorod, Russian Federation
Medical Mycology Scientific Research Institute at St. Petersburg Medical Academy of Postgraduate Studies of Roszdrav
🇷🇺St. Petersburg, Russian Federation
Precision Trials, LLC/Desert West OB/GYN
🇺🇸Glendale, Arizona, United States
Associates Ob/Gyn
🇺🇸Germantown, Tennessee, United States