A Phase 3 study to assess the Efficacy and Safety of VT-1161 Oral Capsules in the Treatment of Subjects with Recurrent yeast infection or vaginal thrush

Phase 1

• Conditions: Recurrent Vulvovaginal Candidiasis; MedDRA version: 20.1Level: PTClassification code 10047784Term: Vulvovaginal candidiasisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2018-001270-26-BE
• Lead Sponsor: Mycovia Pharmaceuticals, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-31
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

1) Subjects must be generally healthy, non-pregnant females 12 years of age and older as of Screening. In Hungary and Czech Republic only, subjects must be generally healthy, non-pregnant females 18 years of age and older as of Screening.
2) Subjects must have a history of recurrent VVC as defined by three (3) or more episodes of acute VVC in the past 12 months, including the episode confirmed at Screening, with at least one episode (not including the current episode) documented by a positive culture, PCR, Affirm test, KOH test, Gram stain or a documented Pap test in the prior 12 months revealing filamentous hyphae/pseudohyphae and/or budding yeast cells.
3) Subjects must have an acute VVC episode at Screening, defined as a total signs and symptoms score of =3 and a positive KOH wet mount preparation or Gram stain from a vaginal smear revealing filamentous hyphae/pseudohyphae and/or budding yeast cells.
4) Subjects must have a composite vulvovaginal signs and symptoms score of <3 at the Baseline (Day 1) Visit.
5) Subjects must have a documented Pap test at Screening or within the current standard of care guidelines for the appropriate age requirement, reported as either negative for intraepithelial lesion or malignancy” or ASCUS-atypical squamous cells of undetermined significance” (not applicable to subjects with a history of total hysterectomy).
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 290
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Subjects must not have the presence of concomitant vulvovaginitis caused by other pathogens (e.g., bacterial vaginosis, Trichomonas vaginalis, Chlamydia trachomatis, or Neisseria gonorrhoeae) at Screening visit and at the Day 1 visit if an infection is suspected.
2) Subjects must not have an active HPV infection as evidenced by visible condylomas on vulvovaginal examination at Screening and Day 1 visits.
3) Subjects must not have the presence or a history of another vaginal or vulvar condition(s) that in the Investigator’s opinion would confound the interpretation of clinical response.
4) Subjects must not have a history of cervical cancer.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified