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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03562156
Other study ID # VMT-VT-1161-CL-011
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date August 16, 2018
Est. completion date August 6, 2021

Study information

Verified date April 2022
Source Mycovia Pharmaceuticals Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 oteseconazole (VT-1161) suggest that it might be a safer and more effective treatment for RVVC than other oral anti-fungal medicines. This study will evaluate the effectiveness and safety of oteseconazole (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 oteseconazole (VT-1161) 150 mg or a placebo (according to a random assignment), and then a 36-week follow-up period. In addition, at participating sites, an amendment to the study allows US patients who complete the initial 48 weeks without experiencing a confirmed RVVC episode to continue in a 48-week observational extension period designed to evaluate the continued effectiveness of oteseconazole (VT-1161). This study is identical to VMT-VT-1161-CL-012 (NCT03561701).


Recruitment information / eligibility

Status Completed
Enrollment 438
Est. completion date August 6, 2021
Est. primary completion date October 19, 2020
Accepts healthy volunteers No
Gender Female
Age group 12 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Oteseconazole (VT-1161)
Oteseconazole (VT-1161) 150mg capsule
Placebo
matching placebo capsule

Locations

Country Name City State
United States 31123 Birmingham Alabama
United States 31120 Bristol Tennessee
United States 31146 Covington Louisiana
United States 31117 Draper Utah
United States 31147 Fall River Massachusetts
United States 31125 Franklin Ohio
United States 31132 Greensboro North Carolina
United States 31102 Houston Texas
United States 31103 Las Vegas Nevada
United States 31118 Las Vegas Nevada
United States 31139 Lauderdale Lakes Florida
United States 31114 Lawrenceville New Jersey
United States 31105 Metairie Louisiana
United States 31107 Metairie Louisiana
United States 31116 Morehead City North Carolina
United States 31111 Norcross Georgia
United States 31134 Philadelphia Pennsylvania
United States 31142 Port Jefferson New York
United States 31144 Raleigh North Carolina
United States 31113 Richmond Virginia
United States 31108 San Diego California
United States 31143 Sarasota Florida
United States 31106 Wellington Florida
United States 31127 West Seneca New York
United States 31145 Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Mycovia Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Subjects With 1 or More Culture-Verified Acute VVC Episodes During the Maintenance Phase of the Study in the Intent-to-Treat Population The primary efficacy outcome measure was the percentage of subjects with 1 or more culture-verified acute VVC episodes during the maintenance phase (post-randomization through Week 48) in the intent-to-treat population. An acute VVC episode during the maintenance phase (considered a recurrent episode) was defined as a positive fungal culture for Candida species and a clinical signs and symptoms score of =3. To calculate the signs and symptoms score, each vulvovaginal sign (erythema, edema, excoriation) and symptom (itching, burning, irritation) was scored using the following scale, with a higher score indicating a worse outcome.
0 = none (complete absence of any sign or symptom), 1 = mild (slight), 2 = moderate (definitely present), 3 = severe (marked, intense)
Maintenance phase (post-randomization through Week 48)
See also
  Status Clinical Trial Phase
Recruiting NCT05074602 - A Study to Evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole in Subjects With Recurrent Vulvovaginal Candidiasis Phase 3
Completed NCT04029116 - Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC) Phase 3
Active, not recruiting NCT04734405 - A Phase IIb/III Study of Prof-001 for the Treatment of Patients With Recurrent Vulvovaginal Candidiasis (RVVC) Phase 2/Phase 3
Completed NCT01067131 - Safety and Immunogenicity Study of a Virosomal Vaccine Against Recurrent Vulvovaginal Candida Infection Phase 1
Completed NCT03840616 - Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections Phase 3
Recruiting NCT04699240 - Study of Lactobacillus in Adjuvant Treatment of RVVC Phase 4
Not yet recruiting NCT04639544 - Effect of a Lactobacillus Strain on the Prevention of Recurrent Vaginal Candidiasis N/A
Completed NCT02267382 - A Study to Evaluate Oral VT-1161 in the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection) Phase 2
Recruiting NCT06190509 - Assessing the Safety, Immune Response, and Early Efficacy of a Candida Vaccine in Women With Recurrent Vulvovaginal Candidiasis: A Randomized Controlled Study Phase 1/Phase 2
Completed NCT03561701 - A Study of Oral Oteseconazole (VT-1161) for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection) Phase 3
Completed NCT05795491 - Blue Light Emitting Diode Therapy on Vulvovaginal Candidiasis N/A
Completed NCT03059992 - Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment Phase 3