Phase 3
Completed N=330
A Study of Oral Oteseconazole (VT-1161) for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
Recurrent Vulvovaginal Candidiasis
Source: ClinicalTrials.gov NCT03561701 ↗
Enrolled (actual)
330
Serious AEs
3.7%
Results posted
Dec 2021
Primary outcomePrimary: Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes During the Maintenance Phase of the Study in the Intent-to-treat (ITT) Population. — 3.9; 39.4 percentage of subjects
◆ Published Evidence
Established
47citations · ~12 / year
Efficacy and Safety of Oteseconazole in Recurrent Vulvovaginal Candidiasis.
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 antifungal 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-011.
Linked Publications (2)
-
Efficacy and Safety of Oteseconazole in Recurrent Vulvovaginal Candidiasis.
-
Oteseconazole (VIVOJA) for prevention of recurrent vulvovaginal candidiasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 (ITT) Population. |
3.9; 39.4 | — |
Eligibility Criteria
Key Inclusion Criteria
- 3 or more episodes of acute VVC in the past 12 months
- Positive KOH or Gram stain test
- 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
Data sourced from ClinicalTrials.gov (NCT03561701) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.