NCT07429071 Effectiveness of a Vaginal Gel on CIN1/2 Regression and HPV Clearance.
| NCT ID | NCT07429071 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Womens Health |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2026-06-09 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2026-06-09 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07429071 clinical trial?
This trial is open to female participants only, aged 30 Years or older, up to 50 Years, studying Womens Health. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07429071 currently recruiting?
Yes, NCT07429071 is actively recruiting participants. Contact the research team at isipinbo@rm.dk for enrollment information.
Where is the NCT07429071 trial being conducted?
This trial is being conducted at Horsens, Denmark, Randers, Denmark.
Who is sponsoring the NCT07429071 clinical trial?
NCT07429071 is sponsored by University of Aarhus. The trial plans to enroll 70 participants.