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Safety and Efficacy of Oral SCY-078 vs. Oral Fluconazole in Subjects With Vulvovaginal Candidiasis

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ClinicalTrials.gov Identifier: NCT02679456
Recruitment Status : Completed
First Posted : February 10, 2016
Last Update Posted : February 20, 2017
Sponsor:
Collaborator:
ethica Clinical Research Inc.
Information provided by (Responsible Party):
Scynexis, Inc.

Brief Summary:
This is a randomized, multicenter, evaluator blinded study to evaluate the safety, tolerability, efficacy and pharmacokinetics of SCY-078 compared to Fluconazole in adult patients with moderate to severe Vulvovaginal Candidiasis (VVC) and a history of frequent episodes of VVC. Approximately 90 subjects, meeting the inclusion criteria will be enrolled and randomized in a 1:1:1 ratio to one of the 3 treatment arms: Oral SCY-078 in 2 dose regimens or oral Fluconazole. After enrollment, subjects will be evaluated on Day-5 (end of treatment visit), Day-24 (test of cure visit), Day-60, Day 90 and Day 120 (end of observation period visit) or at any time that a recurrence or clinical failure is suspected, up to the end of observation period.

Condition or disease Intervention/treatment Phase
Vulvovaginal Candidiasis Drug: SCY-078 Drug: Fluconazole Phase 2

Detailed Description:

This is a randomized, multicenter, evaluator blinded study to evaluate the safety, tolerability, efficacy and pharmacokinetics of SCY-078 compared to Fluconazole in adult patients, from 18 to 65 years of age, with moderate to severe Vulvovaginal Candidiasis (VVC) and a history of frequent episodes of VVC. Approximately 90 subjects, meeting the inclusion criteria will be enrolled and randomized in a 1:1:1 ratio to one of the 3 treatment arms: oral SCY-078 does regimen 1, or oral SCY-078 does regimen 2, or oral Fluconazole. After enrollment, subjects will be evaluated on Day-5 (end of treatment visit), Day-24 (test of cure visit), Day-60, Day 90 and Day 120 (end of observation period visit) or at any time that a recurrence or clinical failure is suspected, up to the end of observation period.

Primary Objectives:

* To evaluate the safety and efficacy of 2 dosing regimens of Oral SCY-078 in subjects with moderate to severe Vulvovaginal Candidiasis (VVC)

Secondary Objectives:

* To estimate the effect of Oral SCY-078 therapy in the rate and time to recurrence in subjects with a history of frequent episodes of VVC


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Evaluator Blinded, Active-Controlled Study to Evaluate the Safety and Efficacy of Oral SCY-078 vs. Oral Fluconazole in Subjects With Vulvovaginal Candidiasis
Study Start Date : November 2015
Actual Primary Completion Date : August 5, 2016
Actual Study Completion Date : August 5, 2016

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Active Comparator: Treatment Group 1 (Fluconazole)
Fluconazole
Drug: Fluconazole
Experimental: Treatment Group 2: (SCY-078)
Dose regimen 1
Drug: SCY-078
Experimental: Treatment Group 3 (SCY-078)
Dose regimen 2
Drug: SCY-078



Primary Outcome Measures :
  1. Proportion of subjects achieving therapeutic cure at the test of cure visit (Day 24 +/-3) [ Time Frame: Day 24 +/- 3 ]
    Therapeutic Cure defined as achieving both a Clinical Cure (resolution of signs and symptoms) and a Mycological Eradication (negative culture).


Secondary Outcome Measures :
  1. Proportion of subjects with recurrence of VVC during the observation period [ Time Frame: 4-month observation period ]
    Recurrence defined as a symptomatic and culture-verified episode of VVC after achieving Therapeutic Cure.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must fulfill all of the following criteria to be eligible for study admission:

  1. Female subjects from 18 to 65 years of age in good general health
  2. Diagnosis of symptomatic moderate to severe vulvovaginal candidiasis
  3. The ability to understand and sign a written informed consent form (ICF), which must be obtained prior to treatment and any study-related procedures.
  4. The ability to understand and sign a consent or authorization form which shall permit the use, disclosure and transfer of the subject's personal health information (e.g., in the U.S. HIPAA Authorization form).
  5. The ability to understand and follow all study-related procedures including study drug administration.
  6. Females of childbearing potential must agree to use a medically acceptable method of contraception while receiving protocol-assigned product.

Exclusion Criteria:

A subject will be excluded from participation in the study if she meets any of the following exclusion criteria:

  1. Any vaginal condition other than VVC that may interfere with the diagnosis or evaluation of response to therapy.
  2. Prior use of any prohibited medication(s) or procedure(s) within the protocol specified timeframe including:

    a. Systemic and/or topical (vaginal) antifungal treatment, prescription or over the counter, within 30 days of the baseline visit.

  3. Subjects with history of renal impairment, hepatic impairment or cervical cancer.

4 Subjects with known hypersensitivity to enfumafungin derivatives, fluconazole or any of the components of the formulation.

5. HIV infection, chemotherapy or illness serious enough to induce an immune deficiency.


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): NCT02679456


Locations
Dominican Republic
Hospital Dr. Francisco E. Moscoso Puello
Santo Domingo, Dominican Republic
Instituto Dermatologico y Cirugia de Piel
Santo Domingo, Dominican Republic
Sponsors and Collaborators
Scynexis, Inc.
ethica Clinical Research Inc.
Investigators
Study Director: David Angulo, MD Scynexis, Inc.

Responsible Party: Scynexis, Inc.
ClinicalTrials.gov Identifier: NCT02679456     History of Changes
Other Study ID Numbers: SCY-078-203
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Vulvovaginal
Mycoses
Vulvovaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
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