A Study of Oral VT-1161 for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:12 - Any
Updated:9/28/2018
Start Date:August 23, 2018
End Date:July 20, 2020
Contact:Stephen Brand, PhD
Email:info@mycovia.com
Phone:919-467-8539

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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VT-1161 Oral Capsules in the Treatment of Subjects With Recurrent Vulvovaginal Candidiasis

Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is
defined as at least 3 episodes of acute VVC in the past 12 months. Several properties of
VT-1161 suggest that it might be a safer and more effective treatment for RVVC than other
oral antifungal medicines.

This study will evaluate the effectiveness and safety of VT-1161 for the treatment of RVVC
and consists of 2 parts. The first part of the study is a 2-week period for the treatment of
the patient's current VVC episode with 3 150mg doses of fluconazole. The 2nd part consists of
12 weeks, when the patient will take either VT-1161 150 mg or a placebo (according to a
random assignment), and then a 36-week follow-up period.

This study is identical to VMT-VT-1161-CL-011.


Key Inclusion Criteria:

- 3 or more episodes of acute VVC in the past 12 months

- Positive KOH or Gram stain

- Total vulvovaginal signs and symptoms score of ≥3 at screening visit

- Total vulvovaginal signs and symptoms score of <3 at baseline visit

- Must be able to swallow pills

Key Exclusion Criteria:

- Presence or a history of another vaginal or vulvar condition(s)

- Evidence of major organ system disease

- History of cervical cancer

- Poorly controlled diabetes mellitus

- Pregnant

- Recent use of topical or systemic antifungal or antibacterial drugs

- Recent use of immunosuppressive or systemic corticosteroid therapies
We found this trial at
14
sites
Phoenix, Arizona 85032
Principal Investigator: Valerie Sorkin-Wells
Phone: 602-931-4507
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20 West Wenger Road
Englewood, Ohio 45322
937-771-5103
Principal Investigator: Stuart Weprin
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Columbus, Ohio 43213
Principal Investigator: Harold Green
Phone: 614-668-6630
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Columbus, Ohio 43231
Principal Investigator: Milroy Samuel
Phone: 614-682-5182
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Columbus, OH
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Frisco, Texas 75035
Principal Investigator: Phyllis Gee
Phone: 469-361-4007
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Hagerstown, Maryland 21740
Principal Investigator: Andrew Oh
Phone: 301-665-9098
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Hartford, Connecticut 06105
Principal Investigator: Alan Fine
Phone: 860-527-3435
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Hartford, CT
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830 North Krome Avenue
Homestead, Florida 33030
Principal Investigator: Norma Roche
Phone: 305-245-3534
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Homestead, FL
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Jackson, Tennessee 38305
Principal Investigator: Lolly Eldridge
Phone: 731-660-8320
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Jackson, TN
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Little Rock, Arkansas 72212
Principal Investigator: Steve Simpson
Phone: 501-954-7822
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Little Rock, AR
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Los Angeles, California 90057
Principal Investigator: Peyman Banooni
Phone: 310-424-5922
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Los Angeles, CA
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North Bay Village, Florida 33141
Principal Investigator: Patricia Bravo
Phone: 305-763-8573
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North Bay Village, FL
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Wichita, Kansas 67226
Principal Investigator: David Grainger
Phone: 316-425-6333
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Winston-Salem, North Carolina 27103
Principal Investigator: Amy Sapp
Phone: 336-768-3456
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Winston-Salem, NC
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