Multi-Center Study of New Medications to Treat Vaginal Infections
NCT ID: NCT02308046
Last Updated: 2020-07-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
212 participants
INTERVENTIONAL
2015-06-30
2017-06-30
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
TRIPLE
Study Groups
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Terconazole vaginal gel
One applicator full at bedtime
Terconazole
Gel vehicle
One applicator full at bedtime
Placebo
Interventions
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Terconazole
Placebo
Eligibility Criteria
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Inclusion Criteria
* Capable of providing written informed consent or assent
* Currently not menstruating and not anticipating menses during treatment
* If heterosexually active, subject must be post-menopausal for ≥ 1 year, surgically sterile, or practicing an acceptable form of birth control
* Negative pregnancy test
* Other criteria as identified in the protocol
Exclusion Criteria
* Subject has recently used, or is expected to require the concomitant use of prohibited medications/products
* Nursing mother
* Use of any investigational drug within 30 days of enrollment
* History of hypersensitivity to any ingredient/component of the formulations
* Other criteria as identified in the protocol
12 Years
FEMALE
No
Sponsors
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Curatek Pharmaceuticals, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Robert J Borgman, Ph.D.
Role: STUDY_DIRECTOR
Curatek Pharmaceuticals
Locations
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University of Alabama
Birmingham, Alabama, United States
New Horizons Clinical Trials
Chandler, Arizona, United States
MomDoc Womens Health Research
Scottsdale, Arizona, United States
NEA Baptist Clinic
Jonesboro, Arkansas, United States
Gossmont Center for Clinical Research
La Mesa, California, United States
Genesis Center for Clinical Research
San Diego, California, United States
Medical Center for Clinical Research
San Diego, California, United States
Downtown Women's Health Care
Denver, Colorado, United States
Red Rocks Ob/Gyn
Lakewood, Colorado, United States
Women's Health CT Ob/Gyn
Bridgeport, Connecticut, United States
KO Clinical Research, LLC
Fort Lauderdale, Florida, United States
Segal Institute for Clinical Research
North Miami, Florida, United States
Discovery Clinical Research
Plantation, Florida, United States
Georgia Regents University
Augusta, Georgia, United States
Atlanta North Gynecology
Roswell, Georgia, United States
Mount Vernon CLinical Research
Sandy Springs, Georgia, United States
Rosemark Womens Care Specialists
Idaho Falls, Idaho, United States
Women's Health Practice
Champaign, Illinois, United States
Praetorian Pharmaceutical Research, LLC
Marrero, Louisiana, United States
Southern Clinical Research Associates
Metairie, Louisiana, United States
Women's Healthcare Specialists, PC
Kalamazoo, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Women's Clinic of Lincoln
Lincoln, Nebraska, United States
Legacy Women's Health
Las Vegas, Nevada, United States
R. Garn Mabey Jr., MD Gynecology
Las Vegas, Nevada, United States
Lawrence Ob/Gyn Clinical Research LLC
Lawrenceville, New Jersey, United States
Women's Health Research Center
Plainsboro, New Jersey, United States
Suffolk OB/GYN
Port Jefferson, New York, United States
East Carolina Women's Center
New Bern, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
Radiant Research
Columbus, Ohio, United States
HWC Women's Research Center
Englewood, Ohio, United States
Drexel University
Philadelphia, Pennsylvania, United States
Philapelphia Clinical Research, LLC
Philadelphia, Pennsylvania, United States
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
James T. Martin, MD
North Charleston, South Carolina, United States
The Jackson Clinic
Jackson, Tennessee, United States
Discovery Clinical Trials
Dallas, Texas, United States
TMC Life Research, Inc.
Houston, Texas, United States
Multicare Women's Center Covington
Covington, Washington, United States
Women's Clinical Research Center
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MTC-001 (Trial 1)
Identifier Type: -
Identifier Source: org_study_id
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