Vaginal Infection Study
1 other identifier
interventional
1,443
4 countries
133
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2008
133 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 4, 2008
CompletedFirst Posted
Study publicly available on registry
February 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedMarch 5, 2012
February 1, 2012
1.9 years
February 4, 2008
February 29, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical symptom resolution.
baseline, 7 to 10 days and 21 to 30 days
Secondary Outcomes (3)
Yeast Culture for Candida
baseline, 7 to 10 days and 21 to 30 days
Gram stain Nugent score
baseline, 7 to 10 days and 21 to 30 days
Saline wet mount for clue cells
baseline, 7 to 10 days and 21 to 30 days
Study Arms (3)
1
EXPERIMENTALclindamycin phosphate/butoconazole nitrate
2
ACTIVE COMPARATORclindamycin phosphate
3
ACTIVE COMPARATORbutoconazole nitrate
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have a clinical diagnosis of vaginal infection.
- Patients must be post-menopausal, surgically sterilized or using an acceptable form of birth control.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (133)
Clinical Research Consultants, Inc
Birmingham, Alabama, 35209, United States
Jefferson Clinic, PC
Birmingham, Alabama, 35233, United States
Choice Research, LLC
Enterprise, Alabama, 36330, United States
Star W. Research
Chandler, Arizona, 85225, United States
Precision Trials, LLC/Desert West OB/GYN
Glendale, Arizona, 85304, United States
Women's Health Research
Phoenix, Arizona, 85015, United States
Precision Trials LLC
Phoenix, Arizona, 85032, United States
Visions Clinical Research - Tucson
Tucson, Arizona, 85712, United States
NEA Women's Clinic
Jonesboro, Arkansas, 33760, United States
Arkansas Primary Care Clinic, PA
Little Rock, Arkansas, 72204, United States
The Woman's Clinic, P.A.
Little Rock, Arkansas, 72205, United States
Precision Clinical Research
Searcy, Arkansas, 72143, United States
Med Center
Carmichael, California, 95608, United States
Universal Biopharma Research Institute, Inc./Alta Family Health Clinic, Inc.
Dinuba, California, 93618, United States
Sierra Medical Research
Fresno, California, 93611, United States
Grossmont Center for Clinical Research
La Mesa, California, 91942, United States
San Diego Clinical Research Center
San Diego, California, 92103, United States
Lynn Institute of the Rockies
Colorado Springs, Colorado, 80909, United States
Red Rocks OB/GYN
Lakewood, Colorado, 80228, United States
Lynn Institute of Pueblo
Pueblo, Colorado, 81001, United States
Women's Health Care Associates, PC
Hartford, Connecticut, 06105, United States
Greater Hartford Womens Association/Women's Health
West Hartford, Connecticut, 06117, United States
Women's Medical Research Group, LLC
Clearwater, Florida, 33759, United States
Segal Institute for Clinical Research
North Miami, Florida, 33161, United States
Physician Care Clinical Research
Sarasota, Florida, 34239, United States
Insignia Clinical Research
Tampa, Florida, 33607, United States
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409, United States
Atlanta Medical Research Institute
Alpharetta, Georgia, 30005, United States
AMR Research Associates
Bogart, Georgia, 30622, United States
Medical Network for Educators and Research
Decatur, Georgia, 30033, United States
Soapstone Center for Clinical Research
Decatur, Georgia, 30034, United States
Atlanta West Women's Center
Douglasville, Georgia, 30134, United States
The Woman's Clinic
Boise, Idaho, 83712, United States
Rosemark Women Care Specialists
Idaho Falls, Idaho, 83404, United States
Womans Health Practice, LLC
Champaign, Illinois, 61820, United States
Northern Indiana Womens Health Research
South Bend, Indiana, 46601, United States
Clinical Trials Management
Mandeville, Louisiana, 70471, United States
Regional Research Specialists, LLC
Shreveport, Louisiana, 71106, United States
New England Center for Clinical Research, Inc.
Fall River, Massachusetts, 02720, United States
Activmed Practices & Research, Inc.
Haverhill, Massachusetts, 01830, United States
Healthcare for Women
New Bedford, Massachusetts, 02740, United States
Female Pelvic Medicine and Urogynecology Institute of Michigan
Grand Rapids, Michigan, 49506, United States
Women's Health Care Specialists, PC
Paw Paw, Michigan, 49079, United States
Women's Health Partner
St Louis, Missouri, 63117, United States
Consultants in Women's Healthcare
St Louis, Missouri, 63131, United States
New Ballas OB-GYN, Inc.
St Louis, Missouri, 63141, United States
The Medical Group of Northern Nevada
Reno, Nevada, 89502, United States
Suffolk Ob/Gyn
Port Jefferson, New York, 11777, United States
Preferred OB/GYN/ Women's Health
Woodbury, New York, 11797, United States
Eastowne OB-GYN and Infertility
Chapel Hill, North Carolina, 27514, United States
Eastern Carolina Women's Center
New Bern, North Carolina, 28562, United States
Hawthorne Medical Research, Inc.
Winston-Salem, North Carolina, 27103, United States
Valaores & Lewis Obstetrics & Gynocology
Winston-Salem, North Carolina, 27103, United States
Mid Dakota Clinic Center for Women
Bismarck, North Dakota, 58501, United States
Complete Healthcare for Women
Columbus, Ohio, 43231, United States
HWC Women's Research Center
Englewood, Ohio, 45322, United States
Holzer Clinic
Gallipolis, Ohio, 45631, United States
Pacific Women's Center, LLC
Eugene, Oregon, 97401, United States
Medford Women's Clinic, LLP
Medford, Oregon, 97504, United States
Laurel Highlands Ob/Gyn, PC
Hopwood, Pennsylvania, 15445, United States
Clinical Trials Research Services, LLC
Natrona Heights, Pennsylvania, 15065, United States
Associates Ob/Gyn
Germantown, Tennessee, 38138, United States
Women's Care Center, PLC
Memphis, Tennessee, 38119, United States
Women Partners in Health
Austin, Texas, 78705, United States
Advanced Research Associates
Corpus Christi, Texas, 78414, United States
Research Across America
El Paso, Texas, 79902, United States
Planned Parenthood of Houston
Houston, Texas, 77004, United States
The Woman's Hospital of Texas Clinical Research Center
Houston, Texas, 77054, United States
TMC Life Research, Inc
Houston, Texas, 77054, United States
Bexar Clinical Trials, LLC
Irving, Texas, 75061, United States
Willowbend Health and Wellness
Plano, Texas, 75093, United States
InVisions Consultants, LLC c/o Northeast Ob/Gyn
San Antonio, Texas, 78217, United States
King's Daughter Clinic
Temple, Texas, 76502, United States
Tanner Clinic
Layton, Utah, 84041, United States
Mt. Timpangos Women's Healthcare
Pleasant Grove, Utah, 84062, United States
Salt Lake Research
Salt Lake City, Utah, 84107, United States
Salt Lake Women's Center
Sandy City, Utah, 84070, United States
Tidewater Clinical Research, Inc
Virginia Beach, Virginia, 23456, United States
Walla Walla Clinic
Walla Walla, Washington, 99362, United States
Hyperion Clinical Research, LLC
Charleston, West Virginia, 25301, United States
Aurora Advanced Healthcare, Inc
Milwaukee, Wisconsin, 53209, United States
Institute of Kidney Disease and Research Centre
Ahmedabad, Gujarat, 380016, India
Krishna Hospital Surgical & Maternity 201/2/3 Suryadeep Complex
Vadodara, Gujarat, 390006, India
Father Muller Medical College Hospital
Mangalore, Kamataka, 575002, India
Neha Prakash Hospital
Bangalore, Karnataka, 560064, India
KMC Hospital
Mangalore, Karnataka, 575001, India
Yenepoya Medical College and Hospital
Mangalore, Karnataka, 575018, India
Om Women's Hospital
Nagpur, Maharashtra, 440010, India
Avanti Institute of Cardiology
Nagpur, Maharashtra, 440012, India
Nagpur Test Tube Baby Centre
Nagpur, Maharashtra, 440022, India
VSG Healthcare, Dr. Ganorkar Hospital
Nashik, Maharashtra, 422001, India
Nivedita Hospital
Nashik, Maharashtra, 422002, India
Deenanath Mangeshkar Hospital and Research Centre
Pune, Maharashtra, 411004, India
KEM Hospital Research Centre
Pune, Maharashtra, 411011, India
Dr. D. Y. Patil Medical College & Hospital
Pune, Maharashtra, India
Sri Ramachandra Medical College
Chennai, Tamil Nadu, 600116, India
Chopra Nursing and Maternity Home
Agra, 282001, India
Yashoda Super Speciality Hospital
Ghaziabad, 201001, India
Government Maternity Hospital
Hyderabad, 500002, India
Government Maternity Hospital
Hyderabad, 500095, India
Makker Medical Center
Lucknow, 226991, India
M.K.W. Hospital and Research Centre
New Delhi, 110027, India
Sri Ramachandra Medical College
Tamil Nadu, 600116, India
Ponce School of Medicine
Ponce, 00716, Puerto Rico
Dermatovenerologic Dispensary
Korolyov, Moscow Oblast, 141074, Russia
D.O. Ott Research Institute of Ob/Gyn--Family Planning and Female Health Center
Mendeleevskaya Line, Sankt-Peterburg, 199034, Russia
D.O. Ott Research Institute of Ob/Gyn--Gynecologic Endocrinology
Mendeleyevskaya, Sankt-Peterburg, 199034, Russia
Orkli, LLC
V.o., Sankt-Peterburg, 199178, Russia
Smolensk State Medical Academy of Roszdrav
Smolensk, Smolensk Oblast, 214019, Russia
Kaluga Regional Dermatovenerologic Dispensary
Kaluga, 24800, Russia
Moscow Regional Research Insitute of Obstetrics and Gynecology
Moscow, 101000, Russia
Dermatovenerologic Dispensary #15
Moscow, 111538, Russia
Family Planning and Reproductive Centre
Moscow, 117152, Russia
The Peoples' Friendship University of Russia
Moscow, 117198, Russia
City Clinical Hospital #52
Moscow, 117997, Russia
City Clinical Hospital #31
Moscow, 119415, Russia
Clinic of Skin and Sexual Transmitted Diseases
Moscow, 119435, Russia
City Clinical Hospital #51
Moscow, 121309, Russia
Nizhegorodskiy Dermatovenerologic Scientific Research Institute of Federal Agency for Public Health and Human Services
Nizhny Novgorod, 603950, Russia
Regional Dermatovenerologic Dispensary
Rostov-on-Don, 344007, Russia
Ryazan Regional Clinical Dermatovenerologic Dispensary
Ryazan, 390046, Russia
Juventa--Reproductive Health
Saint Petersburg, 190020, Russia
Medical Mycology Scientific Research Institute at St. Petersburg Medical Academy of Postgraduate Studies of Roszdrav
Saint Petersburg, 191015, Russia
442 District Military Clinical Hospital of Leningradsky Military District
Saint Petersburg, 191124, Russia
City Dermatovenerologic Dispensary
Saint Petersburg, 192102, Russia
S.M. Kirov Military Medical Academy, MoD of the Russian Federation
Saint Petersburg, 194044, Russia
L.G. Sokolov Clinical Hospital #122 of the Federal Medical-Biologic Agency--#321
Saint Petersburg, 194291, Russia
L.G. Sokolov Clinical Hospital #122 of the Federal Medical-Biologic Agency--#322
Saint Petersburg, 194291, Russia
Leningradskiy Regional Clinical Hospital
Saint Petersburg, 194291, Russia
Family Planning and Reproductive Centre
Saint Petersburg, 195008, Russia
St. Petersburg State I.I. Mechnikov Medical Academy of Roszdrav
Saint Petersburg, 195067, Russia
Andros Clinic, LLC
Saint Petersburg, 197136, Russia
Smolensk Dermatovenerologic Dispensary
Smolensk, 214000, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jim Joffrion
Lumara Health, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2008
First Posted
February 15, 2008
Study Start
January 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
March 5, 2012
Record last verified: 2012-02