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RADIANT: CD101 vs Standard of Care in Subjects With Acute Vaginal Yeast Infections

NCT02733432 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2020-08-31

No results posted yet for this study

Summary

The purpose of this study is to determine if two topical formulations of CD101 are safe and effective in the treatment of acute moderate to severe vulvovaginal candidiasis (VVC) compared to oral fluconazole.

Conditions

  • Candidiasis, Vulvovaginal
  • Mycoses
  • Yeast Infection
  • Moniliasis, Vulvovaginal
  • Vaginitis, Monilial

Interventions

DRUG

CD101 Vaginal Gel (3%)

CD101 Vaginal Gel (3%) intravaginally applied topical gel on Days 1 and 2

DRUG

CD101 External gel (1%)

CD101 external gel (1%) applied topically twice daily over 72 hours as needed

DRUG

CD101 Vaginal Ointment (6%)

CD101 vaginal ointment (6%) intravaginally applied topical ointment on Day 1

DRUG

CD101 External ointment (1%)

CD101 external ointment (1%) applied topically twice daily over 72 hours as needed

DRUG

Fluconazole

oral fluconazole (150mg) on Day 1

Sponsors & Collaborators

  • Cidara Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Alena Jandourek, MD · Cidara Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-08
Primary Completion
2016-11-23
Completion
2016-12-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02733432 on ClinicalTrials.gov