Effectiveness of a Vaginal Gel on CIN1/2 Regression and HPV Clearance.

Recruiting now · Not applicable

Conditions studied: Womens Health, Cervical Dysplasia, Cervical Intraepithelial Neoplasia (CIN), Non-invasive Treatment, Human Papilloma Virus (HPV)

In brief

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.

Key facts

Study ID

NCT07429071

Run by

University of Aarhus

People needed

70

Starts

2026-06-09

Expected to finish

2026-12-01

Last updated by the study team

2026-08-03

Who can join

Age: 30 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Department of Gynaecology and Obstetrics — Horsens, Denmark (enrolling)
• Department of Gynaecology and Obstetrics — Randers, Denmark (enrolling)

Full record on ClinicalTrials.gov

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