Non-Interventional Extension to Investigate Recurrence of Vulvovaginal Candidiasis and Candida Colonization
A Non-Interventional Extension Study to Investigate Vulvovaginal Candidiasis Recurrence and Candida Colonization Following a Phase 2 Randomized, Active-Controlled Study of Two Formulations of CD101 Compared to Fluconazole for the Treatment of Moderate to Severe Episodes of Acute Vulvovaginal Candidiasis
1 other identifier
observational
32
1 country
23
Brief Summary
Non-interventional extension study to investigate VVC recurrence and candida colonization following the P2 acute VVC study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2016
Shorter than P25 for all trials
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 16, 2016
CompletedFirst Submitted
Initial submission to the registry
August 30, 2016
CompletedFirst Posted
Study publicly available on registry
September 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2017
CompletedMarch 2, 2018
February 1, 2018
7 months
August 30, 2016
February 28, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Time to recurrence of clinical signs/symptoms of VVC
Time to recurrence of clinical signs/symptoms of VVC
Up to Day 90 +/- 14 days
Secondary Outcomes (4)
Rate of candida colonization
Up to Day 90 +/- 14 days
Rate of recurrence of clinical signs/symptoms of VVC
Up to Day 90 +/- 14 days
Time to recurrence of culture confirmed VVC
Up to Day 90 +/- 14 days
Rates of recurrence of culture confirmed VVC
Up to Day 90 +/- 14 days
Eligibility Criteria
Females previously enrolled in the primary study (NCT07299432) who had not been diagnosed with recurrence of vulvovaginal candidiasis and successfully completed the Day 28 visit in the primary study.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Precision Trials AZ
Phoenix, Arizona, 85032, United States
The Women's Clinical, P.A.
Little Rock, Arkansas, 72205, United States
Women's Health Care Research Corp
San Diego, California, 92111, United States
Olympian Clinical Research
Clearwater, Florida, 33756, United States
Women's Medical Research
Clearwater, Florida, 33759, United States
Altus Research Inc
Lake Worth, Florida, 33461, United States
New Age Medical Research Corporation
Miami, Florida, 33186, United States
Augusta University
Augusta, Georgia, 30912, United States
Clinical Trials Management LLC
Metairie, Louisiana, 70006, United States
Wayne State University
Detroit, Michigan, 48201, United States
Saginaw Valley Medical Research Group LLC
Saginaw, Michigan, 48604, United States
Lawrence OB GYN Clinical Research LLC
Lawrenceville, New Jersey, 08648, United States
Alliance Women's Research Group LLC
Riverside Park, New Jersey, 08075, United States
Soffolk OB/GYN
Port Jefferson, New York, 11777, United States
Eastern Carolina Women's Center
New Bern, North Carolina, 28562, United States
Hawthorne Medical Research Inc
Winston-Salem, North Carolina, 27103, United States
Unified Women's Clinical Research - Hickory
Winston-Salem, North Carolina, 27103, United States
Women's Health Research
Columbus, Ohio, 43123, United States
Drexel University
Philadelphia, Pennsylvania, 19102, United States
TMC Life Research Inc.
Houston, Texas, 77054, United States
Clinical Trials of Texas Inc
San Antonio, Texas, 78229, United States
Tidwewater Physicians for Women
Norfolk, Virginia, 23502, United States
Seattle Women's Health, Research, Gynecology
Seattle, Washington, 98105, United States
Biospecimen
Candida isolates
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alena Jandourek, MD
Cidara Therapeutics
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2016
First Posted
September 2, 2016
Study Start
August 16, 2016
Primary Completion
March 15, 2017
Study Completion
March 15, 2017
Last Updated
March 2, 2018
Record last verified: 2018-02