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

Sponsor

Cidara Therapeutics Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02733432

Collaborator

(none)

126

Enrollment

Locations

Arms

6.5

Actual Duration (Months)

5.3

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Candidiasis, Vulvovaginal Mycoses Yeast Infection Moniliasis, Vulvovaginal Vaginitis, Monilial	Drug: CD101 Vaginal Gel (3%) Drug: CD101 External gel (1%) Drug: CD101 Vaginal Ointment (6%) Drug: CD101 External ointment (1%) Drug: Fluconazole	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

126 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Masking Description:

Sponsor blinded

Primary Purpose:

Treatment

Official Title:

A Phase 2, Multicenter, Randomized, Active-controlled Study of the Safety and Tolerability of Two Formulations of CD101 Compared to Fluconazole for the Treatment of Moderate to Severe Episodes of Acute Vulvovaginal Candidiasis

Actual Study Start Date :

Jun 8, 2016

Actual Primary Completion Date :

Nov 23, 2016

Actual Study Completion Date :

Dec 23, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 CD101 Vaginal Gel (3%) topically self-administered intravaginally as a single dose on days 1 and 2 and for symptomatic relief CD101 External Gel (1%)topically self-applied to external vulva up to twice per day over 72 hours.	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
Experimental: Cohort 2 CD101 Vaginal Ointment (6%) topically self-administered intravaginally as a single dose on day 1 and for symptomatic relief CD101 External Ointment (1%) topically self-applied to external vulva up to twice per day over 72 hours.	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
Active Comparator: Cohort 3 Oral fluconazole (150mg) administered on day 1.	Drug: Fluconazole oral fluconazole (150mg) on Day 1

Arm

Intervention/Treatment

Experimental: Cohort 1

CD101 Vaginal Gel (3%) topically self-administered intravaginally as a single dose on days 1 and 2 and for symptomatic relief CD101 External Gel (1%)topically self-applied to external vulva up to twice per day over 72 hours.

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

Experimental: Cohort 2

CD101 Vaginal Ointment (6%) topically self-administered intravaginally as a single dose on day 1 and for symptomatic relief CD101 External Ointment (1%) topically self-applied to external vulva up to twice per day over 72 hours.

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

Active Comparator: Cohort 3

Oral fluconazole (150mg) administered on day 1.

Drug: Fluconazole

oral fluconazole (150mg) on Day 1

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Change in Vulvovaginal Scoring System [Day 7 (+/- 2days)]
Change in clinical signs and subject symptoms of VVC
Change in Vulvovaginal Scoring System [Day 14 (+/- 2days)]
Change in clinical signs and subject symptoms of VVC
Change in Vulvovaginal Scoring System [Day 28 - 35]
Change in clinical signs and subject symptoms of VVC
Mycological Culture [Day 7 (+/- 2days)]
Culture negative for Candida
Mycological Culture [Day 14 (+/- 2days)]
Culture negative Candida
Mycological Culture [Day 28 -35]
Culture negative Candida

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Precision Trials AZ LLC	Phoenix	Arizona	United States	85032
3	The Women's Clinical, P.A.	Little Rock	Arkansas	United States	72205
4	Women's Health Care Research Corp	San Diego	California	United States	92111
5	Olympian Clinical Research	Clearwater	Florida	United States	33756
6	Women's Medical Research	Clearwater	Florida	United States	33759
7	Altus Research Inc	Lake Worth	Florida	United States	33461
8	New Age Medical Research Corporation	Miami	Florida	United States	33186
9	Augusta University	Augusta	Georgia	United States	30912
10	Clinical Trials Management LLC	Metairie	Louisiana	United States	70006
11	Tolan Park Clinic	Detroit	Michigan	United States	48201
12	Saginaw Valley Medical Research Group LLC	Saginaw	Michigan	United States	48604
13	Alliance Women's Research Group LLC	Delran	New Jersey	United States	08075
14	Lawrence OB GYN Clinical Research LLC	Lawrenceville	New Jersey	United States	08648
15	ProHEALTH Care Associates, LLP	Port Jefferson	New York	United States	11777
16	Eastern Carolina Women's Center	New Bern	North Carolina	United States	28562
17	Hawthorne Medical Research Inc	Winston-Salem	North Carolina	United States	27103
18	Unified Women's Clinical Research - Hickory	Winston-Salem	North Carolina	United States	27103
19	Aventiv Research Inc	Columbus	Ohio	United States	43123
20	Drexel University College of Medicine	Philadelphia	Pennsylvania	United States	19102
21	TMC Life Research Inc.	Houston	Texas	United States	77054
22	Clinical Trials of Texas Inc	San Antonio	Texas	United States	78229
23	Tidewater Clinical Research, Inc	Norfolk	Virginia	United States	23502
24	Seattle Women's Health, Research, Gynecology	Seattle	Washington	United States	98105