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

Last updated: December 17, 2021
Sponsor: Mycovia Pharmaceuticals Inc.
Overall Status: Completed

Phase

3

Condition

Fungal Infections

Sexually Transmitted Diseases (Stds)

Systemic Fungal Infections

Treatment

N/A

Clinical Study ID

NCT03561701
VMT-VT-1161-CL-012
  • Ages > 12
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion

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

Total Participants: 425
Study Start date:
August 23, 2018
Estimated Completion Date:
August 03, 2021

Connect with a study center

  • 31215

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • 31227

    Little Rock, Arkansas 72212
    United States

    Site Not Available

  • 31217

    Los Angeles, California 90057
    United States

    Site Not Available

  • 31240

    Hartford, Connecticut 06105
    United States

    Site Not Available

  • 31204

    Homestead, Florida 33030
    United States

    Site Not Available

  • 31233

    North Bay Village, Florida 33141
    United States

    Site Not Available

  • 31255

    Wichita, Kansas 67226
    United States

    Site Not Available

  • 31245

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • 31223

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • 31229

    Columbus, Ohio 43231
    United States

    Site Not Available

  • 31244

    Columbus, Ohio 43213
    United States

    Site Not Available

  • 31222

    Englewood, Ohio 45322
    United States

    Site Not Available

  • 31218

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • 31232

    Frisco, Texas 75035
    United States

    Site Not Available

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