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Trial record 3 of 40 for:    DOVE

An Active-Controlled, Dose-Finding Study of SCY-078 vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis (DOVE)

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ClinicalTrials.gov Identifier: NCT03253094
Recruitment Status : Completed
First Posted : August 17, 2017
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Scynexis, Inc.

Brief Summary:
This is a multicenter, randomized, double-blind, double-dummy, active-controlled, dose-finding study to compare the efficacy, safety and tolerability of oral SCY-078 versus oral fluconazole in adult female subjects 18 years and older with moderate to severe Acute Vulvovaginal Candidiasis (AVVC). Approximately 180 eligible subjects (30 subjects per treatment group) will be enrolled and randomized into the study.

Condition or disease Intervention/treatment Phase
Candida Vulvovaginitis Drug: Fluconazole Drug: SCY-078 Phase 2

Detailed Description:
This is a Phase 2, multicenter, randomized, double-blind, double-dummy, active-controlled, dose-ranging study of female subjects with moderate to severe Acute Vulvovaginal Candidiasis. Subjects will be randomized to either the investigational arm (SCY-078) with 5 different dose regiments ranging from 1 to 3 days of treatment or to the active-control arm (fluconazole) for 1 day of treatment. After randomization subjects may be seen on study Day 3 (on site visit for PK subjects) , Day 10 (±2,) and Day 25 (+4).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, double-blind, double-dummy, active-controlled, dose-finding
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Dose-Finding Study to Compare the Safety and Efficacy of Oral SCY-078 vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : May 4, 2018
Actual Study Completion Date : May 4, 2018

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Active Comparator: Fluconazole
150 mg/day for 1 day
Drug: Fluconazole
drug
Other Name: Diflucan, Azole antifungal

Experimental: SCY-078
5 different active dosing groups with 2 different treatment regiments of either 1 or 3 days
Drug: SCY-078
drug




Primary Outcome Measures :
  1. Clinical cure (complete resolution of signs and symptoms) [ Time Frame: 8-12 days ]
    measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit


Secondary Outcome Measures :
  1. Co-occurrence of clinical and mycological cure [ Time Frame: 29 days ]
    The percentage of subjects with both clinical cure and mycological eradication (negative fungal culture) the Test-of cure and follow up visit.


Other Outcome Measures:
  1. Incidence of treatment emergent adverse events [ Time Frame: up to 29 days ]
    The number of subjects with treatment related adverse events



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Subject is a female of at least 18 years of age
  2. Subject has a diagnosis of symptomatic AVVC at baseline including a positive microscopic examination with 10% KOH in a vaginal sample revealing yeast forms (hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5)

Key Exclusion Criteria:

  1. Subject has any vaginal condition other than AVVC that may interfere with the diagnosis or evaluation of response to therapy, such as suspected or confirmed concurrent causes of vulvovaginitis and/or cervicitis (mixed infection)
  2. Need for systemic and/or topical (vaginal) antifungal treatment, including prescription or over-the-counter products during the study and treatment for VVC 28 days prior to randomization
  3. Subject is actively menstruating at the time of the Baseline visit.
  4. Subject has uncontrolled diabetes mellitus.
  5. Subject has a vaginal sample with pH >4.5.
  6. Subject has a history of or an active cervical/vaginal cancer.

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): NCT03253094


  Show 25 Study Locations
Sponsors and Collaborators
Scynexis, Inc.
Investigators
Study Director: David Angulo, MD Scynexis, Inc.

Responsible Party: Scynexis, Inc.
ClinicalTrials.gov Identifier: NCT03253094     History of Changes
Other Study ID Numbers: SCY-078-204
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 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:
Candidiasis
Candidiasis, Vulvovaginal
Vulvovaginitis
Mycoses
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