Vulvovaginal Candidiasis (VVC)NCT06983041
Clinical Study of a Vaginal Cooling Device for the Treatment of Vulvovaginal Candidiasis (VVC)
A study testing vaginal cooling device in people with Vulvovaginal Candidiasis (VVC) and Yeast Vaginitis, run by Coologics, Inc at 10 sites in United States.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 22 to 49 years, women only
- Conditions the study is for
- Vulvovaginal Candidiasis (VVC), Yeast Vaginitis
- What is being tested?
- vaginal cooling device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 10 sitesUnited States
- Study dates
- 22 May 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Site investigators will evaluate the eligibility of women presenting with symptoms consistent with VVC based on the inclusion criteria.
- Women between 22-49 years of age and not more than one year since last menses, with the suspected diagnosis of uncomplicated VVC.
- Able to read and understand English.
- Able to provide written informed consent and to understand and agree to all study procedures required.
- Has a smart phone and has the ability to access and use the ValidCare app.
- Documented Papanicolaou (Pap) test at baseline or during the previous 12 months reported as either "negative for intraepithelial lesion or malignancy" or "ASCUS-atypical squamous cells of undetermined significance" and negative for high-risk HPV types or negative colposcopy plus/minus biopsies were performed for high-risk HPV types.
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- Clinical diagnosis of symptomatic VVC confirmed by positive KOH wet mount and yeast culture at baseline.
- Presence of at least one vulvovaginal sign (vulvovaginal erythema, edema, or excoriation) of VVC.
- Presence of at least one vulvovaginal symptom (itching, pain or burning, irritation)
- Willing and able to avoid vaginal (or any) sexual activity during the study period.
- Menstrual products such as tampons, pads, and menstrual cups may be used during the study period including before and after device use.
Who cannot join
- 1. Site investigators will evaluate the eligibility of women presenting with symptoms consistent with VVC based on the exclusion criteria.
- 2. Subject does not have a smart phone. 3. Subject does not have the ability to access and use the Validcare app. 4. Subjects who were treated for VVC within the past 14 days. 5. Use of systemic, topical (applied to the vulva) or vaginal antibiotics, anti-fungal or anti-trichomonas drugs within 14 days.
- 6. Use of any systemic corticosteroid, immunosuppressive, or immune-stimulating drug within 3 months.
- 7. History of douching within the previous 7 days. 8. Urinary tract infection. 9. Unable or unwillingness to use tampons in the past. 10. Unable to maintain study protocol including but not limited to the avoidance of sexual activity during the 28 days or time interval up to the assessment of the primary endpoint. This is needed to avoid reinfection, worsening of symptoms or new pathogen infection, while assessing the efficacy of the subject device in treating the primary infection.
- 11. Use of anticoagulation therapy (e.g., warfarin, heparin). 12. Diabetes mellitus. 13. History of vulvodynia, vestibulitis, vaginismus, radiation-induced vaginitis, or postmenopausal atrophy.
- 14. Immune compromised states such as HIV/AIDS or transplant subjects. 15. Subjects with other infectious causes of vulvovaginitis or with mixed infections diagnosed at baseline. (Note: if any trichomonad trophozoites are seen on wet smear on the initial visit, the subject is to be excluded from the study.) 16. Symptomatic vulvar or vaginal condyloma or presence of another vaginal or vulvar condition that would confound the interpretation of clinical response.
- 17. Pregnancy. 18. Presence of trichomonad trophozoites on wet smear at the initial visit. 19. Any condition which, in the opinion of the investigator, should preclude participation in the study. If so, the investigator will collect information on the subjects who are determined to have a condition that precludes participation in the study and the reasons for their exclusion documented within the DDCS to ensure there is no bias introduced.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 8 recruiting
- Recruiting
Next Innovative Clinical Research
Chicago, Illinois, 60616
LaToya Hinton, (708) 955-7856, latoya.hinton@nexticr.com
Imani Gardner, imani.gardner@nexticr.com
- Recruiting
Vilo Research Group, Inc.
Houston, Texas, 77070
Jorge Mendez, 832-660-5095, jmendez@viloresearchgroup.com
Tamara Sanchez, tsanchez@viloresearchgroup.com
- Suspended
Leavitt Clinical Research
Idaho Falls, Idaho, 83404
- Recruiting
Symphony Clinical Research
Jacksonville, Florida, 32224
Christian Hering, 8134305500, chering@symphonyresearch.com
Nancy Slay, nancy@symphonyresearch.com
- Active, not recruiting
Aviati Health
Memphis, Tennessee, 38115
- Recruiting
Nova Clinical Research
Miami, Florida, 33162
Lashaun Sanders, RN, 3054071822, lsanders@ihealthclinical.com
Christ-Ann Maglorie, MD
- Recruiting
Unified Women's Clinical Research-Raleigh
Raleigh, North Carolina, 27607
Cassie Harris, 919-788-4449, cassie.harris@unifiedhc.com
Ann Collins, MD
- Recruiting
Pivotal Clinical Research & Associates
Smyrna, Georgia, 30082
Willisha Johnson, 770-376-7912, wjohnson@pivotalcra.com
Melinda Miller-Thrasher, MD
- Recruiting
Renew Health Clinical Research
Snellville, Georgia, 30078
Javonte Maynor, 770-833-0616, javonte.maynor@renewhealthcr.com
Pharonda Lee, pharonda.lee@renewhealthcr.com
- Recruiting
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103
Madelyn Biffle, 336 397 3716, madelyn.biffle@unifiedhc.com
Robert Parker, MD
About this study
Official title: Open-label, Uncontrolled Clinical Research Study of a Vaginal Cooling Device for the Treatment of Vulvovaginal Candidiasis (VVC)
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.
- Conditions
- Vulvovaginal Candidiasis (VVC), Yeast Vaginitis
- Being tested
- vaginal cooling device
- Keywords
- yeast infection
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal cooling deviceDevice
medical grade polymer capsule filled with inert fluid (15 cc's)
| Study group | Role | What they receive |
|---|---|---|
| uncomplicated vulvovaginal candidiasis | Other | 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). Receives: Device: vaginal cooling device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of clinical cures at 7 days
VSS of 0-1(based on severity of infection), KOH negative for Hyphae
Measured: 7 days (+/-2)
Secondary outcomes (1)
Clinical Cure
VSS of 0-1(based on severity of infection), KOH negative for Hyphae
Measured: 28 days (+/-2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start22 May 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvovaginal Candidiasis (VVC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coologics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983041
- Sponsor's protocol ID
- Pro00079644
- Status last verified
- Jan 2026
- First submitted
- 2 May 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Uncontrolled Clinical Research Study of a Vaginal Cooling Device for the Treatment of Vulvovaginal Candidiasis (VVC)
- ClinicalTrials.gov ID
- NCT06983041
- Acronym / sponsor ID
- Pro00079644
- Conditions
- Vulvovaginal Candidiasis (VVC), Yeast Vaginitis
- Keywords
- yeast infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Coologics, IncIndustry (pharma, biotech, devices)
- Study start
- 22 May 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| uncomplicated vulvovaginal candidiasis | Other | Device: vaginal cooling deviceTwice 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 may qualify
- Ages
- 22 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Site investigators will evaluate the eligibility of women presenting with symptoms consistent with VVC based on the inclusion criteria.
Key exclusion criteria (7 listed)
- 1. Site investigators will evaluate the eligibility of women presenting with symptoms consistent with VVC based on the exclusion criteria.
- 2. Subject does not have a smart phone. 3. Subject does not have the ability to access and use the Validcare app. 4. Subjects who were treated for VVC within the past 14 days. 5. Use of systemic, topical (applied to the vulva) or vaginal antibiotics, anti-fungal or anti-trichomonas drugs within 14 days.
- 6. Use of any systemic corticosteroid, immunosuppressive, or immune-stimulating drug within 3 months.
- 7. History of douching within the previous 7 days. 8. Urinary tract infection. 9. Unable or unwillingness to use tampons in the past. 10. Unable to maintain study protocol including but not limited to the avoidance of sexual activity during the 28 days or time interval up to the assessment of the primary endpoint. This is needed to avoid reinfection, worsening of symptoms or new pathogen infection, while assessing the efficacy of the subject device in treating the primary infection.
- 11. Use of anticoagulation therapy (e.g., warfarin, heparin). 12. Diabetes mellitus. 13. History of vulvodynia, vestibulitis, vaginismus, radiation-induced vaginitis, or postmenopausal atrophy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vaginal cooling devicemedical grade polymer capsule filled with inert fluid (15 cc's) | Device | uncomplicated vulvovaginal candidiasis |
Primary outcome
Number of clinical cures at 7 days
Time frame: 7 days (+/-2)
VSS of 0-1(based on severity of infection), KOH negative for Hyphae
1 secondary outcome
Clinical Cure
Time frame: 28 days (+/-2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vaginal cooling device in people with Vulvovaginal Candidiasis (VVC) and Yeast Vaginitis, run by Coologics, Inc at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kimberly J Langdon, MD (740-206-4287, kim@coologics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of clinical cures at 7 days (time frame: 7 days (+/-2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.