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

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

sites

Complete Healthcare for Women

Columbus, Ohio 43231

Principal Investigator: Milroy Samuel

Phone: 614-682-5182

from

Columbus, OH