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NCT Number: NCT02888197

Non-Interventional Extension to Investigate Recurrence of Vulvovaginal Candidiasis and Candida Colonization

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

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Key information

Conditions

Candidiasis, Vulvovaginal Bacterial Infections and Mycoses Candidiasis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Moniliasis, Vulvovaginal Mycoses Urogenital Diseases Vaginal Diseases Vaginitis Vaginitis, Monilial Vulvar Diseases Vulvitis Vulvovaginitis Yeast Infection

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Precision Trials AZ, Phoenix, Arizona, United States

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About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Time to recurrence of clinical signs/symptoms of VVC

    Time frame: Up to Day 90 +/- 14 days

    Time to recurrence of clinical signs/symptoms of VVC

Secondary outcomes

  1. Rate of candida colonization

    Time frame: Up to Day 90 +/- 14 days

    Rate of candida colonization

  2. Rate of recurrence of clinical signs/symptoms of VVC

    Time frame: Up to Day 90 +/- 14 days

    Rate of recurrence of clinical signs/symptoms of VVC

  3. Time to recurrence of culture confirmed VVC

    Time frame: Up to Day 90 +/- 14 days

    Time to recurrence of culture confirmed VVC

  4. Rates of recurrence of culture confirmed VVC

    Time frame: Up to Day 90 +/- 14 days

    Rates of recurrence of culture confirmed VVC

Sponsors and collaborators

Lead sponsor

Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 2, 2016
Registry last updated
Mar 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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