A Study to Evaluate Oral VT-1161 in the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
NCT ID: NCT02267382
Last Updated: 2019-10-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
254 participants
INTERVENTIONAL
2015-02-10
2016-11-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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VT-1161 Low-dose 3-month
1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks
VT-1161
VT-1161 Low-dose 6-month
1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 23 weeks
VT-1161
VT-1161 High-dose 3-month
2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks
VT-1161
VT-1161 High-dose 24-week
2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 23 weeks
VT-1161
Placebo
2 placebo tablets once daily for 7 days, then once weekly for 23 weeks
Placebo
Interventions
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VT-1161
Placebo
Eligibility Criteria
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Inclusion Criteria
3 or more episodes of acute VVC in the past 12 months
Positive KOH
Minimum composite vulvovaginal signs and symptoms score of ≥3 at Screening
Composite vulvovaginal signs and symptoms score of \<3 at Baseline
Must be able to swallow tablets
Exclusion Criteria
Presence or a history of another vaginal or vulvar condition(s)
History of cervical cancer
Poorly controlled diabetes mellitus
Pregnant
Recent use of topical or systemic antifungal drugs
Recent use of immunosuppressive or system corticosteroid therapies
18 Years
65 Years
FEMALE
No
Sponsors
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Viamet
INDUSTRY
Responsible Party
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Locations
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University of Alabama Birmingham
Birmingham, Alabama, United States
Precision Trials
Phoenix, Arizona, United States
NEA Baptist Clinic
Jonesboro, Arkansas, United States
Axis Clinical Trials
Los Angeles, California, United States
Axis Clinical Trials
Los Angeles, California, United States
Genesis Center for Clinical Research
San Diego, California, United States
Altus Research
Lake Worth, Florida, United States
Healthcare Clinical Data
Miami, Florida, United States
Community Medical Research
North Miami, Florida, United States
Vision Clinical Research
Palm Beach, Florida, United States
Physician Care Clinical Research LLC
Sarasota, Florida, United States
Clinical Research of West Florida
Tampa, Florida, United States
Cypress Medical Research Center
Wichita, Kansas, United States
Clinical Trials Management LLC
Covington, Louisiana, United States
Clinical Trials Management LLC
Metairie, Louisiana, United States
New England Center for Clinical Research
Fall River, Massachusetts, United States
Clinical Research of Nevada
Las Vegas, Nevada, United States
R. Garn Mabey, Jr. M.D. Chartered
Las Vegas, Nevada, United States
OB/GYN Clinical Research
Lawrenceville, New Jersey, United States
Women's Health Research Center
Plainsboro, New Jersey, United States
Suffolk OB-GYN
Port Jefferson, New York, United States
United Women's Clinical Research-Raleigh
Raleigh, North Carolina, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States
Radiant Research
Akron, Ohio, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
Magee Women's Hospital
Pittsburgh, Pennsylvania, United States
Brownstone Clinical Trials
Fort Worth, Texas, United States
TMC Life Research
Houston, Texas, United States
Brownstone Clinical Trials
Irving, Texas, United States
Clinical Trials of Texas
San Antonio, Texas, United States
Physician's Research Options LLC
Sandy City, Utah, United States
Seattle Women's Health Research Gynecology
Seattle, Washington, United States
Countries
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References
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Vanreppelen G, Nysten J, Baldewijns S, Sillen M, Donders G, Van Dijck P. Oteseconazole (VIVOJA) for prevention of recurrent vulvovaginal candidiasis. Trends Pharmacol Sci. 2023 Jan;44(1):64-65. doi: 10.1016/j.tips.2022.10.004. Epub 2022 Nov 14. No abstract available.
Brand SR, Degenhardt TP, Person K, Sobel JD, Nyirjesy P, Schotzinger RJ, Tavakkol A. A phase 2, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of orally administered VT-1161 in the treatment of recurrent vulvovaginal candidiasis. Am J Obstet Gynecol. 2018 Jun;218(6):624.e1-624.e9. doi: 10.1016/j.ajog.2018.03.001. Epub 2018 Mar 11.
Other Identifiers
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VMT-VT-1161-CL-006
Identifier Type: -
Identifier Source: org_study_id
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