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

NCT ID: NCT03561701

Last Updated: 2021-12-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

425 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-23

Study Completion Date

2021-08-03

Brief Summary

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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

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Conditions

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Recurrent Vulvovaginal Candidiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Oteseconazole (VT-1161) 150mg capsule

Once daily for 7 days starting at Day 1, followed by once weekly for 11 weeks

Group Type EXPERIMENTAL

Oteseconazole (VT-1161)

Intervention Type DRUG

Oteseconazole (VT-1161) 150mg capsule

Placebo capsule

Once daily for 7 days starting at Day 1, followed by once weekly for 11 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

matching placebo capsule

Interventions

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Oteseconazole (VT-1161)

Oteseconazole (VT-1161) 150mg capsule

Intervention Type DRUG

Placebo

matching placebo capsule

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

12 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mycovia Pharmaceuticals Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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31215

Phoenix, Arizona, United States

Site Status

31227

Little Rock, Arkansas, United States

Site Status

31217

Los Angeles, California, United States

Site Status

31240

Hartford, Connecticut, United States

Site Status

31204

Homestead, Florida, United States

Site Status

31233

North Bay Village, Florida, United States

Site Status

31255

Wichita, Kansas, United States

Site Status

31245

Hagerstown, Maryland, United States

Site Status

31223

Winston-Salem, North Carolina, United States

Site Status

31244

Columbus, Ohio, United States

Site Status

31229

Columbus, Ohio, United States

Site Status

31222

Englewood, Ohio, United States

Site Status

31218

Jackson, Tennessee, United States

Site Status

31232

Frisco, Texas, United States

Site Status

Countries

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United States

References

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Sobel JD, Donders G, Degenhardt T, Person K, Curelop S, Ghannoum M, Brand SR. Efficacy and Safety of Oteseconazole in Recurrent Vulvovaginal Candidiasis. NEJM Evid. 2022 Aug;1(8):EVIDoa2100055. doi: 10.1056/EVIDoa2100055. Epub 2022 Jul 26.

Reference Type DERIVED
PMID: 38319878 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36396498 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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VMT-VT-1161-CL-012

Identifier Type: -

Identifier Source: org_study_id