Vaginal Infection Study 2
1 other identifier
interventional
843
3 countries
73
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2008
73 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
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 9, 2008
CompletedFirst Posted
Study publicly available on registry
June 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedMarch 5, 2012
February 1, 2012
1.5 years
June 9, 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 (2)
1
EXPERIMENTALclindamycin phosphate/butoconazole nitrate
2
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 (73)
Brookwood Ob-GYN, PC/Women's Medical Plaza
Birmingham, Alabama, 35209, United States
Drug Research Analysis Corp
Montgomery, Alabama, 36106, United States
Drug Research and Analysis Corp.
Montgomery, Alabama, 36106, United States
Ob/Gyn Associates
Jonesboro, Arkansas, 72401, United States
The Woman's Clinic, PA
Little Rock, Arkansas, 72205, United States
Peak Health Medical Group
Los Angeles, California, 90025, United States
Women's Health Care at Frost Street
San Diego, California, 30035, United States
Steven Freedman, MD, Inc.
West Hills, California, 91307, United States
Red Rocks OB/GYN
Lakewood, Colorado, 80228, United States
SHE Medical Center
Hartford, Connecticut, 06105, United States
Debra Hemsath, MD
Largo, Florida, 33774, United States
International Research Associates
Miami, Florida, 33156, United States
Suncoast Clinical Research
Palm Harbor, Florida, 34684, United States
University Clinical Research
Pines, Florida, 33024, United States
Total Women's Health and Wellness
Decatur, Georgia, 30030, United States
Dekalb Gynecology Associates
Decatur, Georgia, 30035, United States
New Millennium Ob/Gyn
Riverdale, Georgia, 30274, United States
The Woman's Clinic
Boise, Idaho, 83712, United States
The Iowa Clinic Department of Ob/Gyn
West Des Moines, Iowa, 50266, United States
Steven Z. Lenowitz, MD, LLC
Bel Air, Maryland, 21014, United States
Lawrence Ob/Gyn Associates
Lawrenceville, New Jersey, 08648, United States
Women's Health Research Center, LLC
Lawrenceville, New Jersey, 08648, United States
Triangle Ob/Gyn
Cary, North Carolina, 27518, United States
Women's Wellness Center
Fayetteville, North Carolina, 28304, United States
Meridian Clinical Research, LLC
Greensboro, North Carolina, 27455, United States
Holzer Clinic
Gallipolis, Ohio, 45631, United States
Family Practice Center of Wadsworth, Inc
Wadsworth, Ohio, 44281, United States
Lynn Institute of Norman
Norman, Oklahoma, 73069, United States
Pacific Women's Center, LLC/Clinical Trials of America
Eugene, Oregon, 97401, United States
Center for Women's Health of Lansdale
Lansdale, Pennsylvania, 19446, United States
Creekside Women's Care
Charleston, South Carolina, 29414, United States
The Family Healthcare Center, PA
Clinton, South Carolina, 29325, United States
Greenville Pharmaceutical Research
Greenville, South Carolina, 29615, United States
James T. Martin, Jr., MD, Ob/Gyn
North Charleston, South Carolina, 29406, United States
Brown Clinical, PLLP
Watertown, South Dakota, 57201, United States
Gynecology and Obstetrics
Memphis, Tennessee, 38120, United States
Mid-South Ob/Gyn
Memphis, Tennessee, 38120, United States
Kaner Medical Group, PA
Euless, Texas, 76039, United States
Advanced Reserch Associates
McAllen, Texas, 78505, United States
Willowbend Health & Wellness
Plano, Texas, 75093, United States
Taylor/Wade Medical
Bountiful, Utah, 84010, United States
Vermont Urogynecology Associates, PC
Williston, Vermont, 05495, United States
Tidewater Clinical Research
Virginia Beach, Virginia, 23456, United States
Bangalore Diabetes Centre
Bangalore, Karnataka, 560043, India
AJ Medical College and Hospital
Mangalore, Karnataka, 575004, India
Mayani Hosptial and Research Centre
Ajmer, Rajasthan, 305001, India
Sharda Hospital
Jaipur, Rajasthan, 302020, India
MV Hospital and Research Centre
Lucknow, Uttar Pradesh, 226003, India
Care Hospital
Hyderabad, 500034, India
Shri Krishna Hospital
Jaipur, 302001, India
Mediciti Institute of Medical Sciences
Ranga Reddy District, 501401, India
Krishna Institute of Medical Sciences
Secunderabad, 500003, India
King George Hospital
Visakhapatnam, 530002, India
Kurortniy Ward City Hospital #40
Sestroretsk, Sankt-Peterburg, 197706, Russia
Medical University Clinic
Kazan', 420012, Russia
Clinical Dermatovenerologic Dispensary
Krasnodar, 350020, Russia
State Dermatovenerology Research Center of the Federal Agency for Provision of High Technology Medical Aid
Moscow, 107076, Russia
State Health Care Institution Moscow City Clinical Hospital #12
Moscow, 115516, Russia
Russian Medical Academy of Postgraduate Studies of Roszdrav
Moscow, 123995, Russia
State Healthcare Institution Moscow Clinical Hospital #68
Moscow, 127473, Russia
Novisibirsk Municipal Dermatovenerologic Dispensary #1
Novosibirsk, 630082, Russia
State Health Care Institution Orenburg Regional Clinical Hospital #2
Orenburg, 460000, Russia
Republican Dermatovenerologic Dispensary, MoH of Karelia Republic
Petrozavodsk, 185002, Russia
Maximillian City Hospital #28
Saint Petersburg, 190000, Russia
State Healthcare Institution Regional Dermatovenerologic Dispensary
Saint Petersburg, 190020, Russia
S.M. Kirov Military Medical Academy, MoD of the Russian Federation
Saint Petersburg, 194044, Russia
City Multifield Hospital
Saint Petersburg, 194354, Russia
Medical Research Institute, LLC
Saint Petersburg, 196084, Russia
City Hospital #26
Saint Petersburg, 196247, Russia
St. Petersburg I.P. Pavlov State Medical University of Roszdrav
Saint Petersburg, 197022, Russia
Railway Clinic Hospital of the Voronezh-,1 Railway Station, RJD JSC
Voronezh, 394024, Russia
Voronezh Regional Clinical Dermatovenerologic Dispensary
Voronezh, 394038, Russia
Yaroslavl Regional Maternity Hospital
Yaroslavl, 150003, 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
June 9, 2008
First Posted
June 11, 2008
Study Start
May 1, 2008
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
March 5, 2012
Record last verified: 2012-02