Candidiasis, Vulvovaginal, Moniliasis, Vulvovaginal, Mycoses, Vaginitis, Monilial, Yeast Infection
Conditions
Brief 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.
Detailed description
This is a Phase 2, multicenter, randomized, open-label, sponsor-blind, active-controlled, dose-ranging trial of female subjects with an acute moderate to severe episode of vulvovaginal candidiasis. Subjects will be randomized to 1 of 3 treatment arms; CD101 gel, CD101 ointment, or oral fluconazole. After randomization, subjects will be seen on Day 7 (+/-2 days), Day 14 (+/- 2 days), & Day 28 (+/-7 days) to assess therapeutic cure and safety.
Interventions
DRUGCD101 Vaginal Gel (3%)
CD101 Vaginal Gel (3%) intravaginally applied topical gel on Days 1 and 2
DRUGCD101 External gel (1%)
CD101 external gel (1%) applied topically twice daily over 72 hours as needed
DRUGCD101 Vaginal Ointment (6%)
CD101 vaginal ointment (6%) intravaginally applied topical ointment on Day 1
DRUGCD101 External ointment (1%)
CD101 external ointment (1%) applied topically twice daily over 72 hours as needed
DRUGFluconazole
oral fluconazole (150mg) on Day 1
Sponsors
Cidara Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Sponsor blinded
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* moderate to severe acute vulvovaginal candidiasis (severity score \>7) * positive potassium hydroxide wet preparation for pseudohyphae or budding yeast or positive Becton Dickinson Affirm test or positive vaginal culture for Candida species * vaginal pH \<4.5 for subjects with positive potassium hydroxide wet preparation * able to give written informed consent
Exclusion criteria
* receipt of intravaginal or systemic antifungal therapy within 7 days of randomization * known or suspected infectious causes of vulvovaginitis other than candidiasis * history of genital herpes * planned treatment or surgery during the study period for cervical intraepithelial neoplasia or cervical carcinoma * need for non-protocol systemic or vaginal antifungal therapy * history of hypersensitivity or allergic reaction to echinocandins, azoles, or their excipients * pregnant females * females who are breast feeding * women intending to become pregnant during the study period * recent use of an investigational medicinal product within 28 days or presence of an investigational device at the time of screening * subjects who use or anticipate use of intravaginal products * have any condition that the Investigator believes would put the subject at risk for participation or would confound the results of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects with Incidence of Treatment Emergent Adverse Events [Safety and Tolerability] | Day 28 - 35 | adverse events, clinical chemistry and hematology, pelvic exams |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vulvovaginal Scoring System | Day 7 (+/- 2days) | Change in clinical signs and subject symptoms of VVC |
| Mycological Culture | Day 7 (+/- 2days) | Culture negative for Candida |
Countries
United States
Outcome results
None listed