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:6/30/2018
Start Date:June 2015
End Date:June 2017

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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 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
41
sites
Lakewood, Colorado 80228
Principal Investigator: Kellee Oberle, MD
Phone: 303-985-9100
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20 West Wenger Road
Englewood, Ohio 45322
937-771-5103
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Englewood, OH
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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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Augusta, GA
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Birmingham, Alabama 35294
Principal Investigator: Jane Schwebke, MD
Phone: 480-305-7423
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Birmingham, AL
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Bridgeport, Connecticut 06606
Principal Investigator: Anjali Mehta, MD
Phone: 203-372-4167
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Champaign, Illinois 61820
Principal Investigator: Suzanne Trupin, MD
Phone: 217-356-3736
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1950 West Frye Road
Chandler, Arizona 85224
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Columbus, Ohio 43212
Principal Investigator: Harold Green, MD
Phone: 614-655-8581
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17700 Southeast 272nd Street
Covington, Washington 98042
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Dallas, TX
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Denver, Colorado 80218
Principal Investigator: Arthur Waldbaum, MD
Phone: 303-293-3733
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Fort Lauderdale, Florida 33316
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Houston, Texas 77054
Principal Investigator: Mark Jacobs, MD
Phone: 713-799-1635
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Houston, TX
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Idaho Falls, Idaho 83404
Principal Investigator: Steven Robison, MD
Phone: 208-557-2981
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Jackson, Tennessee 38301
Principal Investigator: Stephen Hammond, MD
Phone: 731-660-8320
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Jonesboro, Arkansas 72401
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7110 Stadium Drive
Kalamazoo, Michigan 49009
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La Mesa, California 91942
Principal Investigator: Gioi Smith-Nguyen, MD
Phone: 619-589-4100
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Las Vegas, Nevada 89123
Principal Investigator: Timothy Sauter, MD
Phone: 702-893-8968
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Las Vegas, Nevada 89128
Principal Investigator: Garn Mabey, MD
Phone: 702-242-8800
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Lawrenceville, New Jersey 08648
Principal Investigator: Steven Sussman, MD
Phone: 609-803-2378
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Lincoln, Nebraska 68510
Principal Investigator: James Maly, MD
Phone: 402-441-0025
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Marrero, Louisiana 70072
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Metairie, Louisiana 70001
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801 McCarthy Boulevard
New Bern, North Carolina 28562
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9213 University Boulevard
North Charleston, South Carolina 29406
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North Miami, Florida 33161
Principal Investigator: Steven Chavoustie, MD
Phone: 305-722-8444
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Philadelphia, Pennsylvania 19114
Principal Investigator: Eugene Andruczyk, DO
Phone: 215-676-6696
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3301 Lancaster Avenue
Philadelphia, Pennsylvania 19102
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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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Plainsboro, New Jersey 08536
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Plantation, Florida 33324
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Port Jefferson, New York 11777
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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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Roswell, Georgia 30075
Principal Investigator: Howard Reisman, MD
Phone: 770-992-2691
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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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San Diego, California 92108
Principal Investigator: William Koltun, MD
Phone: 619-521-2830
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San Diego, California 92103
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Sandy Springs, Georgia 30328
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Scottsdale, Arizona 85251
Principal Investigator: Micah Harris, MD
Phone: 205-975-5665
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Seattle, Washington 98105
Principal Investigator: Robin Kroll, MD
Phone: 206-522-3330
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