Multi-Center Study of New Medications to Treat Vaginal Infections

Completed · Phase 3

Conditions studied: Vaginal Infection

In brief

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

Key facts

Study ID

NCT02308007

Run by

Curatek Pharmaceuticals, LLC

People needed

475

Starts

2015-06-01

Expected to finish

2018-06-01

Last updated by the study team

2020-08-04

Who can join

Age: 12 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Precision Trials, AZ — Phoenix, Arizona, United States
• MomDoc Womens Health Research — Scottsdale, Arizona, United States
• DelSol Research — Tucson, 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
• Precision Clinical Research — Coral Springs, Florida, 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
• Comprehensive Clinical Trials, LLC — West Palm Beach, 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
• Indiana University — Indianapolis, Indiana, United States
• Praetorian Pharmaceutical Research, LLC — Marrero, Louisiana, United States
• Southern Clinical Research Associates — Metairie, Louisiana, United States
• Alabama Clinical Therapeutics — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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