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New treatment option for Vulvovaginal Candidiasis (VVC)
Official title Clinical Study of a Vaginal Cooling Device for the Treatment of Vulvovaginal Candidiasis (VVC)
ClinicalTrials.gov ID: NCT06983041
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 49, women only
You may be able to join if
- Site investigators will evaluate the eligibility of women presenting with symptoms consistent with VVC based on the .
- 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.
You likely can't join if
- 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. people who were treated for VVC...
- 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...
- 11\. Use of anticoagulation therapy (e.g., warfarin, heparin). 12. Diabetes mellitus. 13. History of vulvodynia, vestibulitis, vaginismus...
- 14\. Immune compromised states such as HIV/AIDS or transplant people. 15. people with other infectious causes of vulvovaginitis or with mixed...
See the full eligibility criteria
- Site investigators will evaluate the eligibility of women presenting with symptoms consistent with VVC based on the .
- 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...
- 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.
- 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. people who were treated for VVC within the past 14 days. 5. Use of systemic, topical (applied to the...
- 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...
- 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 people. 15. people with other infectious causes of vulvovaginitis or with mixed infections diagnosed at baseline. (Note: if any trichomonad trophozoites are...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Smyrna, Georgia, United States
- Snellville, Georgia, United States
- Idaho Falls, Idaho, United States
- Chicago, Illinois, United States
- Raleigh, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Memphis, Tennessee, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 22 years to 49 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States; Miami, Florida, United States; Smyrna, Georgia, United States; Snellville, Georgia, United States; Idaho Falls, Idaho, United States; Chicago, Illinois, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.