Non-Interventional Extension to Investigate Recurrence of Vulvovaginal Candidiasis and Candida Colonization
Status: | Completed |
---|---|
Conditions: | Infectious Disease, Women's Studies |
Therapuetic Areas: | Immunology / Infectious Diseases, Reproductive |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/17/2018 |
Start Date: | August 16, 2016 |
End Date: | March 15, 2017 |
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
Non-interventional extension study to investigate VVC recurrence and candida colonization
following the P2 acute VVC study
following the P2 acute VVC study
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.
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.
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
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Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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