A Study of Oral Oteseconazole (VT-1161) for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)

Phase 3

Completed

• Conditions: Recurrent Vulvovaginal Candidiasis
• Interventions: Drug: Oteseconazole (VT-1161); Drug: Placebo

• Registration Number: NCT03561701
• Lead Sponsor: Mycovia Pharmaceuticals Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-01
• Study First Submitted QC: 2018-06-18
• Study First Posted: 2018-06-19
• Study Start: 2018-08-23
• Primary Completion: 2020-10-13
• Study Completion: 2021-08-03
• Results First Submitted: 2021-10-12
• Status Verified: 2021-12
• Results First Submitted QC: 2021-12-17
• Last Update Submitted: 2021-12-17
• Results First Posted: 2021-12-20
• Last Update Posted: 2021-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 425

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oteseconazole (VT-1161) 150mg capsule	Oteseconazole (VT-1161)	Once daily for 7 days starting at Day 1, followed by once weekly for 11 weeks
Placebo capsule	Placebo	Once daily for 7 days starting at Day 1, followed by once weekly for 11 weeks

Primary Outcome Measures

Name	Time	Method
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.	Maintenance phase (post-randomization through Week 48)	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)

Trial Locations

Locations (14)

31223; 🇺🇸 Winston-Salem, North Carolina, United States

31218; 🇺🇸 Jackson, Tennessee, United States

31232; 🇺🇸 Frisco, Texas, United States

31244; 🇺🇸 Columbus, Ohio, United States

31204; 🇺🇸 Homestead, Florida, United States

31217; 🇺🇸 Los Angeles, California, United States

31240; 🇺🇸 Hartford, Connecticut, United States

31222; 🇺🇸 Englewood, Ohio, United States

31215; 🇺🇸 Phoenix, Arizona, United States

31233; 🇺🇸 North Bay Village, Florida, United States

31255; 🇺🇸 Wichita, Kansas, United States

31227; 🇺🇸 Little Rock, Arkansas, United States

31245; 🇺🇸 Hagerstown, Maryland, United States

31229; 🇺🇸 Columbus, Ohio, United States