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

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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 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.

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
We found this trial at
23
sites
99 Brice Road North
Columbus, Ohio 43123
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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4671 S. Congress Ave.
Lake Worth, Florida 33461
561-641-0404
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Lake Worth, FL
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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Augusta, Georgia 30912
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Clearwater, Florida 33757
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Clearwater, Florida 33759
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5045 U.S. 130
Delran, New Jersey 08075
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Houston, Texas 77054
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Lawrenceville, New Jersey 08648
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Little Rock, Arkansas 72205
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Metairie, Louisiana 70006
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New Bern, North Carolina 28562
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Norfolk, Virginia 23502
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3301 Lancaster Avenue
Philadelphia, Pennsylvania 19102
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Phoenix, Arizona 85032
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118 North Country Road
Port Jefferson, New York 11777
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Saginaw, MI
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San Diego, California 92123
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Seattle, WA
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Winston-Salem, North Carolina 27103
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Winston-Salem, North Carolina 27103
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