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:9/27/2018
Start Date:August 16, 2018
End Date:July 20, 2020
Contact:Stephen Brand, PhD
Email:info@mycovia.com
Phone:919-467-8539

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Trial Summary
Trial Overview
Inclusion Criteria

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-012.


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
28
sites
Virtus Research Consultants, LLC
Wellington, Florida 33470
Principal Investigator: Seth Herbst
Phone: 561-231-5028
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Altus Research
4671 S. Congress Ave.
Lake Worth, Florida 33461
561-641-0404
Principal Investigator: Samuel Lederman
Phone: 561-257-3278
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Primary Care Assoc
Anderson, South Carolina 29621
Principal Investigator: Erin Cooksey
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University of Alabama
Birmingham, Alabama 35294
Principal Investigator: Jane Schwebke
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Holston Medical Group
Bristol, Tennessee 37620
Principal Investigator: Dennis Samuel
Phone: 423-990-2415
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Clinical Trials Management LLC
Covington, Louisiana
Principal Investigator: Albert Tydings
Phone: 985-900-2400
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Physicians Research Options
Draper, Utah 84020
Principal Investigator: Michael Twede
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NECCR of Fall River
Fall River, Massachusetts 02720
Principal Investigator: Stephen Kasparian
Phone: 508-672-7450
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Fall River, MA
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HillTop Obstetrics & Gynecology
200 Medical Center Drive
Franklin, Ohio 45005
Principal Investigator: Ronald Hirth
Phone: 513-846-1905
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Unified Women's Clinical Research-Greensboro
Greensboro, North Carolina 27401
Principal Investigator: Mark Anderson
Phone: 336-544-3327
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TMC Life Research, Inc
Houston, Texas 77054
Principal Investigator: Mark Jacobs
Phone: 713-799-1635
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Rex Garn Mabey, Jr., M.D.
2881 North Tenaya Way
Las Vegas, Nevada 89128
Principal Investigator: Garn Mabey
Phone: 702-242-8800
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Clinical Research Center of Nevada, LLC
Las Vegas, Nevada 89104
Principal Investigator: Timothy Sauter
Phone: 702-893-8968
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Precision Clinical Research
4700 North State Road 7
Lauderdale Lakes, Florida 33319
Principal Investigator: Linda Green
Phone: 954-915-9991
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Lawrence Ob-Gyn Assoc., PC
Lawrenceville, New Jersey 08648
Principal Investigator: Steven Sussman
Phone: 609-803-2378
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Southern Clinical Research Assoc - Metarie
Metairie, Louisiana 70001
Principal Investigator: Samuel Alexander
Phone: 504-810-4414
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Metairie, LA
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Clinical Trials Management
Metairie, Louisiana 70006
Principal Investigator: Robert Deck
Phone: 504-455-1310
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Unified Women's Clinical Research - Morehead City
611 North 35th Street
Morehead City, North Carolina 28557
Principal Investigator: Thomas Vradelis
Phone: 252-247-4297
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Women Under Study, LLC
New Orleans, Louisiana 70115
Principal Investigator: Neil Wolfson
Phone: 504-891-3613
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Brighton Clinical Research Assoc
Norcross, Georgia 30095
Principal Investigator: Gerardo Sotomayor
Phone: 770-939-5102
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Drexel University College of Medicine
2900 W Queen Ln
Philadelphia, Pennsylvania 19129
(215) 991-8100
Principal Investigator: Paul Nyirjesy
Phone: 215-762-7442
Drexel University College of Medicine Drexel University College of Medicine represents the consolidation of two...
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ProHEALTH Care Associates
Port Jefferson, New York 11777
Principal Investigator: Lance Edwards
Phone: 631-656-4060
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Unified Women's Clinical Research Raleigh
3100 Duraleigh Road
Raleigh, North Carolina 27607
Principal Investigator: Robert Littleton
Phone: 919-788-4449
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Clinical Trials of Virginia
Richmond, Virginia 23225
Principal Investigator: Prescott Prillaman
Phone: 804-330-9410
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Women's Health Care
San Diego, California 92123
Principal Investigator: Rovena Reagan
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Physician Care Clinical Research, LLC
Sarasota, Florida 34321
Principal Investigator: Gregory Swor
Phone: 941-954-2355
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OB.GYN Associates of Western NY
West Seneca, New York 14224
Principal Investigator: Jeffrey Constantine
Phone: 716-249-6700
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Unified Womens Clinical Research - Lyndhurst
Winston-Salem, North Carolina 27103
Principal Investigator: Robert Parker
Phone: 336-397-3715
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