Vaginal Cooling Device for Yeast Infections

Clinical Study of a Vaginal Cooling Device for the Treatment of Vulvovaginal Candidiasis (VVC)

Recruiting N/A Interventional Study
Vulvovaginal Candidiasis (VVC) Yeast Vaginitis
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
22 – 49
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
55 (estimated)
Sponsor
Coologics, Inc · Industry
Who this trial is looking for

This trial is looking for women aged 22 to 49 with yeast infections. Participants will use a vaginal cooling device and provide feedback about their symptoms and experiences during the study.

Are You a Good Fit for This Trial?
Rules you out Diabetes mellitusHIV/AIDSVulvodyniaVestibulitisVaginismusPregnancy

You may be able to join if

  • I am a woman aged 22 to 49 years.
  • I have symptoms of a yeast infection.
  • I can read and understand English.
  • I can use a smartphone and the ValidCare app.
  • I have not had a period in the last year.
  • I have had a recent Pap test with normal results.
  • I agree to avoid sexual activity during the study.

You may not be able to join if

  • I do not have a smartphone.
  • I was treated for a yeast infection in the last 14 days.
  • I have used antibiotics or antifungal medications in the last 14 days.
  • I have a urinary tract infection.
  • I cannot use tampons.
  • I am currently pregnant.
  • I have a history of certain vaginal conditions like vulvodynia.
  • I have another infection or condition that affects my vulva or vagina.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

The objective of this study is to determine clinical cure rate and safety of a proprietary Vaginal Cooling Device (VCD) in women with VCC. In addition, the safety, mycological cure rates, the speed and efficacy of symptom resolution, vaginal hyphae and polymorphonuclear (PMN) scores, and Quality-of-Life (QoL) parameters will be determined.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Site investigators will evaluate the eligibility of women presenting with symptoms consistent with VVC based on the inclusion criteria. 1. Women between 22-49 years of age and not more than one year since last menses, with the suspected diagnosis of uncomplicated VVC. 2. …
Contacts

Kimberly J Langdon, MD

740-206-4287

kim@coologics.com

CONTACT

Keith Aqua, MD

561-951-8212

kaqua@acrcfl.com

CONTACT