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Trial record 4 of 10 for:    cd101

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

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ClinicalTrials.gov Identifier: NCT02733432
Recruitment Status : Completed
First Posted : April 11, 2016
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Cidara Therapeutics Inc.

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 Type : Interventional  (Clinical Trial)
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 : June 8, 2016
Actual Primary Completion Date : November 23, 2016
Actual Study Completion Date : December 23, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections
Drug Information available for: Fluconazole

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




Primary Outcome Measures :
  1. Number of Subjects with Incidence of Treatment Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Day 28 - 35 ]
    adverse events, clinical chemistry and hematology, pelvic exams


Secondary Outcome Measures :
  1. Change in Vulvovaginal Scoring System [ Time Frame: Day 7 (+/- 2days) ]
    Change in clinical signs and subject symptoms of VVC

  2. Change in Vulvovaginal Scoring System [ Time Frame: Day 14 (+/- 2days) ]
    Change in clinical signs and subject symptoms of VVC

  3. Change in Vulvovaginal Scoring System [ Time Frame: Day 28 - 35 ]
    Change in clinical signs and subject symptoms of VVC

  4. Mycological Culture [ Time Frame: Day 7 (+/- 2days) ]
    Culture negative for Candida

  5. Mycological Culture [ Time Frame: Day 14 (+/- 2days) ]
    Culture negative Candida

  6. Mycological Culture [ Time Frame: Day 28 -35 ]
    Culture negative Candida



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02733432


  Show 24 Study Locations
Sponsors and Collaborators
Cidara Therapeutics Inc.
Investigators
Study Director: Alena Jandourek, MD Cidara Therapeutics

Responsible Party: Cidara Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT02733432     History of Changes
Other Study ID Numbers: CD101.TP.2.01
First Posted: April 11, 2016    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infection
Mycoses
Candidiasis
Vaginitis
Candidiasis, Vulvovaginal
Vaginal Diseases
Genital Diseases, Female
Vulvovaginitis
Vulvitis
Vulvar Diseases
Fluconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors