Non-Interventional Extension to Investigate Recurrence of Vulvovaginal Candidiasis and Candida Colonization
Study Details
Study Description
Brief Summary
Non-interventional extension study to investigate VVC recurrence and candida colonization following the P2 acute VVC study
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Time to recurrence of clinical signs/symptoms of VVC [Up to Day 90 +/- 14 days]
Time to recurrence of clinical signs/symptoms of VVC
Secondary Outcome Measures
- Rate of candida colonization [Up to Day 90 +/- 14 days]
Rate of candida colonization
- Rate of recurrence of clinical signs/symptoms of VVC [Up to Day 90 +/- 14 days]
Rate of recurrence of clinical signs/symptoms of VVC
- Time to recurrence of culture confirmed VVC [Up to Day 90 +/- 14 days]
Time to recurrence of culture confirmed VVC
- Rates of recurrence of culture confirmed VVC [Up to Day 90 +/- 14 days]
Rates of recurrence of culture confirmed VVC
Eligibility Criteria
Criteria
Inclusion Criteria:
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Enrollment in and completed the primary study through the Day 28 visit.
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Received at least one dose of study drug in the primary study
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Able to give written informed consent prior to completion of the primary study
Exclusion Criteria:
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Received systemic or topical vaginal non-study antifungal therapy at any time during the primary study
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Diagnosed with bacterial vaginosis, trichomonas, gonorrhea, chlamydia, or active herpes at any point during the primary study
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The Principal Investigator considers that the subject should not participate in the study
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Precision Trials AZ | Phoenix | Arizona | United States | 85032 |
2 | The Women's Clinical, P.A. | Little Rock | Arkansas | United States | 72205 |
3 | Women's Health Care Research Corp | San Diego | California | United States | 92111 |
4 | Olympian Clinical Research | Clearwater | Florida | United States | 33756 |
5 | Women's Medical Research | Clearwater | Florida | United States | 33759 |
6 | Altus Research Inc | Lake Worth | Florida | United States | 33461 |
7 | New Age Medical Research Corporation | Miami | Florida | United States | 33186 |
8 | Augusta University | Augusta | Georgia | United States | 30912 |
9 | Clinical Trials Management LLC | Metairie | Louisiana | United States | 70006 |
10 | Wayne State University | Detroit | Michigan | United States | 48201 |
11 | Saginaw Valley Medical Research Group LLC | Saginaw | Michigan | United States | 48604 |
12 | Alliance Women's Research Group LLC | Delran | New Jersey | United States | 08075 |
13 | Lawrence OB GYN Clinical Research LLC | Lawrenceville | New Jersey | United States | 08648 |
14 | Soffolk OB/GYN | Port Jefferson | New York | United States | 11777 |
15 | Eastern Carolina Women's Center | New Bern | North Carolina | United States | 28562 |
16 | Hawthorne Medical Research Inc | Winston-Salem | North Carolina | United States | 27103 |
17 | Unified Women's Clinical Research - Hickory | Winston-Salem | North Carolina | United States | 27103 |
18 | Women's Health Research | Columbus | Ohio | United States | 43123 |
19 | Drexel University | Philadelphia | Pennsylvania | United States | 19102 |
20 | TMC Life Research Inc. | Houston | Texas | United States | 77054 |
21 | Clinical Trials of Texas Inc | San Antonio | Texas | United States | 78229 |
22 | Tidwewater Physicians for Women | Norfolk | Virginia | United States | 23502 |
23 | Seattle Women's Health, Research, Gynecology | Seattle | Washington | United States | 98105 |
Sponsors and Collaborators
- Cidara Therapeutics Inc.
Investigators
- Study Director: Alena Jandourek, MD, Cidara Therapeutics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CD101.TP.2.02