Recurrent Vulvovaginal Candidiasis MedDRA version: 20.1 Level: PT Classification code 10047784 Term: Vulvovaginal candidiasis System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Mycovia Pharmaceuticals, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects must be generally healthy, post-menarchal, non-pregnant females 12 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, or other approved diagnostic tests. 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of oral VT-1161 in the treatment of RVVC through Week 48;Secondary Objective: • To evaluate the safety and tolerability of oral VT-1161 in the treatment of RVVC through Week 48. • To evaluate the impact of oral VT-1161 treatment on patient reported outcomes through Week 48.;Primary end point(s): The primary efficacy outcome measure is the proportion of subjects with one or more culture-verified acute VVC episodes during the Maintenance Phase (post-randomization through Week 48) in the ITT population. An acute VVC episode during the Maintenance Phase (considered a recurrent episode) is defined as a positive culture for Candida species and a clinical signs and symptoms score of =3.;Timepoint(s) of evaluation of this end point: post-randomization through Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The key secondary efficacy outcome measures include the following: a. Time to first recurrence of a culture-verified acute VVC episode with signs and symptoms score =3 during the Maintenance Phase. b. The proportion of subjects with at least one positive culture for Candida during the Maintenance Phase. c. The proportion of subjects with at least one culture-verified acute VVC episode with signs and symptoms of =3 post randomization through Week 24. d. Change from Screening through Week 48 in the SF-36 mental component score (MCS). e. Change from Screening through Week 48 in the SF-36 patient reported outcome survey total score.;Timepoint(s) of evaluation of this end point: post-randomization through Week 48 post-randomization through Week 24 (c) | — |
Countries
Bulgaria, Canada, Japan, Poland, United Kingdom, United States
Contacts
Public ContactClinical Trials Admin
Mycovia Pharmaceuticals, Inc
Outcome results
None listed