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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02888197

Enrollment

Registered

2016-09-02

Start date

2016-08-16

Completion date

2017-03-15

Last updated

2018-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results