Vaginal Cooling Device for Vaginal Yeast Infection

Recruiting at 4 trial locations

Overseen By Keith Aqua, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Coologics, Inc

Must not be taking: Antibiotics, Antifungals, Corticosteroids, Anticoagulants

Disqualifiers: Diabetes, HIV/AIDS, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

55 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a Vaginal Cooling Device to evaluate its effectiveness and safety in treating vaginal yeast infections. The researchers aim to determine how quickly and effectively symptoms such as itching or burning improve. Women who have experienced symptoms like itching or pain from a yeast infection and haven't received recent treatment may qualify for this trial. As an unphased trial, it offers participants a chance to contribute to innovative research and potentially experience symptom relief.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications, such as antibiotics, antifungal drugs, and immune-related drugs, for a specific period before joining. You must not have used these medications within the last 14 days or 3 months, depending on the type.

What prior data suggests that this Vaginal Cooling Device is safe for treating vaginal yeast infections?

Research has shown that intravaginal cooling can effectively relieve symptoms of a vaginal yeast infection without medication. This method changes the Candida albicans fungus from its harmful form back to a less troublesome yeast form. Although direct data on the safety of the Vaginal Cooling Device (VCD) is limited, its non-drug nature suggests it is likely well-tolerated.

Devices that don't involve medication generally tend to have fewer side effects. However, individual experiences may vary. Prospective trial participants should discuss any concerns with the study team or their doctor to make an informed decision. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for vaginal yeast infections, like antifungal creams or oral medications, work by targeting and killing the yeast causing the infection. However, the vaginal cooling device offers a unique approach by using temperature to alleviate symptoms. Unlike traditional treatments, this device cools the vaginal area, potentially reducing inflammation and discomfort quickly without the need for medication. Researchers are excited because this non-invasive method could provide rapid relief and might be especially beneficial for those who prefer to avoid or cannot tolerate antifungal drugs.

What evidence suggests that this Vaginal Cooling Device is effective for vaginal yeast infection?

Research has shown that cooling inside the vagina effectively relieves symptoms of vaginal yeast infections. Studies have found that cooling changes Candida albicans, the fungus causing the infection, back into a less harmful form. This process reduces swelling and breaks down the protective layers that shield the fungus. Participants in this trial will use a vaginal cooling device, which previous cases suggest provides immediate symptom relief and may prevent future infections. This makes the cooling device a promising non-drug option for treating vaginal yeast infections. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for women aged 22-49 with suspected uncomplicated vaginal yeast infections, who have had a recent Pap test and are not sexually active during the study. Participants must be able to use a smartphone app for the trial, understand English, and provide consent.

Inclusion Criteria

I can read and understand English.

I can sign and understand all the study documents.

I have a smartphone and can use the ValidCare app.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Twice daily use of vaginal cooling device for 30 minutes a time for three days

1 week

Follow-up

Participants are monitored for clinical cure and safety, including mycological cure rates and symptom resolution

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vaginal Cooling Device

Trial Overview The study tests a Vaginal Cooling Device (VCD) on women with vulvovaginal candidiasis to see if it's safe and effective in curing the infection, relieving symptoms quickly, improving quality of life, and reducing signs like inflammation.

How Is the Trial Designed?

Group I: uncomplicated vulvovaginal candidiasis Experimental Treatment 1 Intervention

Twice daily use of vaginal cooling device for 30 minutes a time for three days (i.e., 3 hours total) in female subjects with VVC age 22-49 (inclusive).

Who Is Running the Clinical Trial?

Coologics, Inc

Lead Sponsor

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11998563/

Use of Intravaginal Cooling to Provide Symptom Relief in ... This study demonstrates intravaginal cooling as an effective, nonpharmacologic approach to reduce symptoms by reverting Candida albicans hyphae to yeast.

2. ajog.org ajog.org/article/S0002-9378(24)00955-4/fulltext

Pilot Case Series of a Vaginal Cooling Device for the ... VCD provides immediate reduction of symptomatology by forcing the hyphae back to the dormant yeast stage, eliminating inflammation, and destroying biofilms. ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06983041

NCT06983041 | Clinical Study of a Vaginal Cooling Device ... Twice daily use of vaginal cooling device for 30 minutes a time for three days (i.e., 3 hours total) in female subjects with VVC age 22-49 (inclusive).

4. academic.oup.com academic.oup.com/jid/article-abstract/231/4/e813/7953302

Use of Intravaginal Cooling to Provide Symptom Relief in ... Current therapies for vulvovaginal candidiasis often fail to prevent recurrences. This study demonstrates intravaginal cooling as an effective, nonpharmaco.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39804954/

Use of Intravaginal Cooling to Provide Symptom Relief in ... The purpose of this study was to evaluate the efficacy of an intravaginal cooling device (Vlisse) in women with VVC to provide symptom relief.

6. withpower.com withpower.com/trial/phase-candidiasis-4-2025-d133a

Vaginal Cooling Device for Vaginal Yeast Infection The objective of this study is to determine clinical cure rate and safety of a proprietary Vaginal Cooling Device (VCD) in women with VCC.

7. go.drugbank.com go.drugbank.com/conditions/DBCOND0032341

Vulvovaginal Candidiasis (DBCOND0032341) Clinical Study of a Vaginal Cooling Device for the Treatment of Vulvovaginal Candidiasis (VVC) ... Safety of Natamycin and Lactulose Vaginal Suppositories in ...