Multi-Center Study of New Medications to Treat Vaginal Infections

Completed · Phase 3 · Has a placebo group

Conditions studied: Vaginal Infection

In brief

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

Key facts

Study ID

NCT02308046

Run by

Curatek Pharmaceuticals, LLC

People needed

212

Starts

2015-06-01

Expected to finish

2017-06-01

Last updated by the study team

2020-07-27

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
• 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

Full record on ClinicalTrials.gov

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