Multi-Center Study of New Medications to Treat Vaginal Infections



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:12 - Any
Updated:7/1/2018
Start Date:June 2015
End Date:June 2018

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Trial Summary
Trial Overview
Inclusion Criteria

Solubilized Metronidazole And/oR Terconazole Gels Intra-Vaginal Efficacy and Safety

The purpose of this study is to evaluate the safety and efficacy of terconazole/metronidazole
gel in the treatment of vaginal infections


Inclusion Criteria:

- A clinical diagnosis of vaginal infection that is confirmed by laboratory testing and:

- 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:

- Other infectious causes of vulvovaginitis

- 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
We found this trial at
51
sites
Augusta University
1120 15th Street
Augusta, Georgia 30912
(706) 721-0211
Principal Investigator: Daron Ferris, MD
Phone: 706-721-8944
Georgia Regents University Georgia Regents University, home of the Medical College of Georgia, is one...
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Wayne State University
5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Principal Investigator: Jack Sobel, M.D.
Phone: 313-745-0448
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Detroit, MI
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Indiana University
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Chemen Neal, MD
Phone: 317-948-7624
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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University of Alabama
Birmingham, Alabama 35294
Principal Investigator: Jane Schwebke, MD
Phone: 480-305-7423
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Birmingham, AL
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Alabama Clinical Therapeutics, Llc
Birmingham, Alabama 35235
Principal Investigator: Ronald Orso, M.D.
Phone: 205-271-5664
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Birmingham, AL
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Women's Health CT Ob/Gyn
Bridgeport, Connecticut 06606
Principal Investigator: Anjali Mehta, MD
Phone: 203-372-4167
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Bridgeport, CT
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Women's Health Practice
Champaign, Illinois 61820
Principal Investigator: Suzanne Trupin, MD
Phone: 217-356-3736
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Champaign, IL
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Radiant Research, Inc
Columbus, Ohio 43212
Principal Investigator: Harold Green, MD
Phone: 614-655-8581
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Columbus, OH
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Complete Healthcare for Women
Columbus, Ohio 43231
Principal Investigator: Milroy Samuel, MD
Phone: 614-682-5182
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Columbus, OH
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Precision Clinical Research
4700 State Road 7
Coral Springs, Florida 33065
Principal Investigator: Linda Green, M.D.
Phone: 954-347-6214
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Discovery Clinical Trials
Dallas, Texas
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Downtown Women's Health Care
Denver, Colorado 80218
Principal Investigator: Arthur Waldbaum, MD
Phone: 303-293-3733
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KO Clinical Research, LLC
Fort Lauderdale, Florida 33316
Principal Investigator: Khadra Osman, M.D.
Phone: 954-467-8049
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Signature GYN Services, Pllc
Fort Worth, Texas 76104
Principal Investigator: John Whitfield, MD
Phone: 817-927-2229
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TMC Life Research, Inc
Houston, Texas 77054
Principal Investigator: Mark Jacobs, MD
Phone: 713-799-1635
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Houston, TX
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Texas Children's Hospital for Women
6651 Main Street
Houston, Texas 77030
Principal Investigator: Kelly Hodges, M.D.
Phone: 832-824-0404
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Rosemark Womens Care Specialists
Idaho Falls, Idaho 83404
Principal Investigator: Steven Robison, MD
Phone: 208-557-2981
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Idaho Falls, ID
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Jackson Clinic, PA
Jackson, Tennessee 38301
Principal Investigator: Stephen Hammond, MD
Phone: 731-660-8320
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Jackson, TN
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NEA Baptist Clinic
Jonesboro, Arkansas 72401
Phone: 870-936-8406
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Jonesboro, AR
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Women's Healthcare Specialists, PC
7110 Stadium Drive
Kalamazoo, Michigan 49009
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Kalamazoo, MI
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Gossmont Center for Clinical Research
La Mesa, California 91942
Principal Investigator: Gioi Smith-Nguyen, MD
Phone: 619-589-4100
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Red Rocks OB/GYN
Lakewood, Colorado 80228
Principal Investigator: Kellee Oberle, MD
Phone: 303-985-9100
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Legacy Women's Health
Las Vegas, Nevada 89123
Principal Investigator: Timothy Sauter, MD
Phone: 702-893-8968
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Las Vegas, NV
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R. Garn Mabey Jr., MD Gynecology
Las Vegas, Nevada 89128
Principal Investigator: Garn Mabey, MD
Phone: 702-242-8800
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Lawrence OB-GYN Clinical Research, LLC
Lawrenceville, New Jersey 08648
Principal Investigator: Steven Sussman, MD
Phone: 609-803-2378
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Women's Clinic of Lincoln, PC
Lincoln, Nebraska 68510
Principal Investigator: James Maly, MD
Phone: 402-441-0025
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Lincoln, NE
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Praetorian Pharmaceutical Research, LLC
Marrero, Louisiana 70072
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Southern Clinical Research Associates
Metairie, Louisiana 70001
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Magnolia OB/GYN Research Center
Myrtle Beach, South Carolina 29572
Principal Investigator: Helena Kirkpatrick, MD
Phone: 843-449-0803
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Myrtle Beach, SC
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East Carolina Women's Center
801 McCarthy Boulevard
New Bern, North Carolina 28562
Principal Investigator: Jeffrey Michelson, MD
Phone: 252-633-3942
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New Bern, NC
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Women Under Study, LLC
New Orleans, Louisiana 70115
Principal Investigator: Jane Miller, MD
Phone: 504-891-3613
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New Orleans, LA
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James T. Martin, MD
9213 University Boulevard
North Charleston, South Carolina 29406
Principal Investigator: James T Martin, MD
Phone: 843-572-7123
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The Segal Institute of Clinical Research
North Miami, Florida 33161
Principal Investigator: Steven Chavoustie, MD
Phone: 305-722-8444
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Philapelphia Clinical Research, LLC
Philadelphia, Pennsylvania 19114
Principal Investigator: Eugene Andruczyk, DO
Phone: 215-676-6696
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Drexel University
3301 Lancaster Avenue
Philadelphia, Pennsylvania 19102
Principal Investigator: Paul Nyirjesy, MD
Phone: 215-762-7442
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Precision Trials AZ
Phoenix, Arizona 85032
Principal Investigator: Valerie Sorkin-Wells, MD
Phone: 602-931-4507
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Magee-Womens Hospital of UPMC
300 Halket St.
Pittsburgh, Pennsylvania 15213
1-866-MyMagee (696-2433)
Principal Investigator: Harold Wiesenfeld, MD
Phone: 412-641-5455
Magee-Womens Hospital of UPMC Magee-Womens Hospital of UPMC is a world-class center for both women's...
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Women's Health Research Center
Plainsboro, New Jersey 08536
Principal Investigator: Scott Eder, MD
Phone: 609-799-5010
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Discovery Clinical Research
Plantation, Florida 33324
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Suffolk OB-GYN
Port Jefferson, New York 11777
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Port Jefferson, NY
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Wake Research Associates, LLC
3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Atlanta North Gynecology, PC
Roswell, Georgia 30075
Principal Investigator: Howard Reisman, MD
Phone: 770-992-2691
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Roswell, GA
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Washington University School of Medicine
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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Medical Center for clinical research
San Diego, California 92108
Principal Investigator: William Koltun, MD
Phone: 619-521-2830
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San Diego, CA
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Genesis Center For Clinical Research
San Diego, California 92103
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Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia 30328
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MomDoc Womens Health Research
Scottsdale, Arizona 85251
Principal Investigator: Micah Harris, MD
Phone: 205-975-5665
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Women's Clinical Research Center
Seattle, Washington 98105
Principal Investigator: Robin Kroll, MD
Phone: 206-522-3330
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Harborview Medical Center
325 9th Ave
Seattle, Washington 98104
(206) 744-3300
Principal Investigator: Jeanne Marrazzo, MD
Phone: 206-685-8169
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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DelSol Research
850 North Kolb Road
Tucson, Arizona 85710
Principal Investigator: Paige Brainard, M.D.
Phone: 520-257-3881
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Comprehensive Clinical Trials
West Palm Beach, Florida 33409
Principal Investigator: Ronald Ackerman, M.D.
Phone: 561-478-3177
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