Effectiveness of a Vaginal Gel on CIN1/2 Regression and HPV Clearance. (NCT07429071) | Clinical Trial Compass
RecruitingNot Applicable
Effectiveness of a Vaginal Gel on CIN1/2 Regression and HPV Clearance.
Denmark70 participantsStarted 2026-06-09
Plain-language summary
The goal of this clinical trial is to evaluate whether a Coriolus versicolor-based vaginal gel facilitates HPV clearance in women aged 30-50 years diagnosed with HPV and CIN1 or CIN2. In addition, the study will investigate whether the gel promotes regression of CIN1/CIN2, assessment of patient satisfaction, treatment compliance and characterize the vaginal microbiome.
The primary outcomes therefore is:
• hrHPV clearance from baseline to follow-up (6 months)
In this randomized controlled study, eligible participants will be randomized 1:1 into two groups:
1. Intervention group: Women (n=35) will apply a CV-based vaginal gel (Papilocare®) daily for 21 days for 3 months. Afterward, the gel should be used every other day for an additional 3 months. Every month includes a 7-day break due to menstruation (28 days cycle).
2. Control group; Women (n=35) will follow the conventional "wait and see" approach.
Who can participate
Age range
30 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Aged 30-50 years
* A positive hrHPV test with histopathological confirmed CIN1 or CIN2
* Managed under a 'watchful waiting' strategy as part of standard management
* Understand Danish, both written and orally
Exclusion criteria:
* Pregnancy or breastfeeding
* Unexplained vaginal bleeding
* Immunosuppressive or immunomodulatory conditions or treatment
* Diabetes mellitus
* Prior hysterectomy
* Any ongoing cancer diagnosis, prior CIN3 or a history of malignancy in the genital/anal region within 5 years (excl. non-melanoma skin cancer)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.