Non-Interventional Extension to Investigate Recurrence of Vulvovaginal Candidiasis and Candida Colonization

NCT ID: NCT02888197

Last Updated: 2018-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-16

Study Completion Date

2017-03-15

Brief Summary

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Non-interventional extension study to investigate VVC recurrence and candida colonization following the P2 acute VVC study

Detailed Description

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Following completion of the 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 (NCT07299432), subjects without a recurrence of VVC will be followed up to an additional 90 days +/- 14 days to assess candida colonization and recurrence of VVC.

Conditions

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Candidiasis, Vulvovaginal Yeast Infection Mycoses Moniliasis, Vulvovaginal Vaginitis, Monilial

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Enrollment in and completed the primary study through the Day 28 visit.
* Received at least one dose of study drug in the primary study
* Able to give written informed consent prior to completion of the primary study

Exclusion Criteria

* Received systemic or topical vaginal non-study antifungal therapy at any time during the primary study
* Diagnosed with bacterial vaginosis, trichomonas, gonorrhea, chlamydia, or active herpes at any point during the primary study
* The Principal Investigator considers that the subject should not participate in the study
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cidara Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alena Jandourek, MD

Role: STUDY_DIRECTOR

Cidara Therapeutics

Locations

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Precision Trials AZ

Phoenix, Arizona, United States

Site Status

The Women's Clinical, P.A.

Little Rock, Arkansas, United States

Site Status

Women's Health Care Research Corp

San Diego, California, United States

Site Status

Olympian Clinical Research

Clearwater, Florida, United States

Site Status

Women's Medical Research

Clearwater, Florida, United States

Site Status

Altus Research Inc

Lake Worth, Florida, United States

Site Status

New Age Medical Research Corporation

Miami, Florida, United States

Site Status

Augusta University

Augusta, Georgia, United States

Site Status

Clinical Trials Management LLC

Metairie, Louisiana, United States

Site Status

Wayne State University

Detroit, Michigan, United States

Site Status

Saginaw Valley Medical Research Group LLC

Saginaw, Michigan, United States

Site Status

Lawrence OB GYN Clinical Research LLC

Lawrenceville, New Jersey, United States

Site Status

Alliance Women's Research Group LLC

Riverside Park, New Jersey, United States

Site Status

Soffolk OB/GYN

Port Jefferson, New York, United States

Site Status

Eastern Carolina Women's Center

New Bern, North Carolina, United States

Site Status

Hawthorne Medical Research Inc

Winston-Salem, North Carolina, United States

Site Status

Unified Women's Clinical Research - Hickory

Winston-Salem, North Carolina, United States

Site Status

Women's Health Research

Columbus, Ohio, United States

Site Status

Drexel University

Philadelphia, Pennsylvania, United States

Site Status

TMC Life Research Inc.

Houston, Texas, United States

Site Status

Clinical Trials of Texas Inc

San Antonio, Texas, United States

Site Status

Tidwewater Physicians for Women

Norfolk, Virginia, United States

Site Status

Seattle Women's Health, Research, Gynecology

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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CD101.TP.2.02

Identifier Type: -

Identifier Source: org_study_id

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