What is the vaginal cooling device studying for vulvovaginal candidiasis?

The vaginal cooling device is being studied to determine its clinical cure rate and safety in women with vulvovaginal candidiasis, a common yeast infection. Researchers aim to evaluate how well the device resolves symptoms and improves quality of life. The study is sponsored by Coologics, Inc.

Who may be eligible for this vulvovaginal candidiasis clinical trial?

Women between 22 and 49 years old with a confirmed diagnosis of uncomplicated vulvovaginal candidiasis may be eligible. Participants must be female, able to use a smartphone app, and able to avoid vaginal sexual activity during the study. Please review eligibility criteria for more details.

Is there any cost to participate in this vulvovaginal candidiasis clinical trial?

Study-related care, including the device and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase Not Applicable

Age: 22Years - 49Years

FEMALE

ID06983041

Study of a Vaginal Cooling Device to Treat Vulvovaginal Candidiasis in Women Aged 22 to 49

Led by Coologics, Inc · Updated on 2026-01-30

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the clinical cure rate and safety of a specialized Vaginal Cooling Device VCD in women with uncomplicated vulvovaginal candidiasis VVC, a yeast infection affecting the vagina. The study also aims to assess the safety, fungal cure rates, speed and effectiveness of symptom relief, vaginal hyphae and immune cell counts, as well as quality-of-life measures related to VVC. Participants will use the vaginal cooling device, which is a medical-grade polymer capsule filled with inert fluid, twice daily for 30 minutes each time over three days, totaling 3 hours of use. This open-label, uncontrolled study involves women aged 22 to 49 who have confirmed VVC. There is no placebo or comparison group, and the device use is monitored to evaluate its effects. Women in the study will undergo clinical diagnosis and confirmation of VVC by laboratory tests at baseline. Researchers will monitor the number of clinical cures at 7 days, with follow-up at 28 days to assess ongoing cure rates. Participants will avoid vaginal sexual activity during the study and use a smartphone app to support study procedures. Safety, symptom resolution, and quality-of-life changes will be closely tracked throughout the study period, which concludes by June 2026.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 22Years - 49Years

FEMALE

Eligibility Criteria

You may qualify if you...

Women aged 22 to 49 years, no more than one year since last menses, with suspected uncomplicated vulvovaginal candidiasis (VVC)
Able to read and understand English
Able to provide written informed consent and agree to study procedures
Owns a smartphone and can access and use the ValidCare app
Has a documented Pap test within the past 12 months with negative or low-risk results
Clinical diagnosis of symptomatic VVC confirmed by positive KOH wet mount and yeast culture
Presence of at least one vulvovaginal sign such as redness, swelling, or skin irritation
Presence of at least one symptom including itching, pain, burning, or irritation
Willing and able to avoid vaginal sexual activity during the study period
Permitted to use menstrual products such as tampons, pads, or cups during the study

You will not qualify if you...

Does not own a smartphone or cannot use the ValidCare app
Treatment for VVC within the past 14 days
Use of systemic, topical vulvar, or vaginal antibiotics, antifungal, or anti-trichomonas drugs within 14 days
Use of systemic corticosteroids, immunosuppressive, or immune-stimulating drugs within 3 months
History of douching within 7 days prior to study
Current urinary tract infection
Unable or unwilling to use tampons
Unable to follow study protocol, including avoiding sexual activity during the study
Use of anticoagulation therapy such as warfarin or heparin
Diabetes mellitus
History of vulvodynia, vestibulitis, vaginismus, radiation-induced vaginitis, or postmenopausal atrophy
Immunocompromised conditions such as HIV/AIDS or transplant
Other infectious vulvovaginitis or mixed infections at baseline
Symptomatic vulvar or vaginal condyloma or other confounding vaginal or vulvar conditions
Pregnancy
Presence of trichomonad trophozoites on initial wet smear
Any condition deemed by the investigator to preclude participation

Research Team

Kimberly J Langdon, MD

Keith Aqua, MD

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Study of a Vaginal Cooling Device to Treat Vulvovaginal Candidiasis in Women Aged 22 to 49

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria