EICHORCondition: Womens Health · Cervical Dysplasia · Cervical Intraepithelial Neoplasia (CIN) · Sponsor: University of Aarhus
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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.
This description comes directly from the study's public registry record.
Pinar Bor, Professor, MD, Ph.D. · 22504767 · isipinbo@rm.dk
Vibe M Bertelsen, Post.Doc, MD, Ph.D. · vibebert@rm.dk
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
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)
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Department of Gynaecology and Obstetrics | Horsens, Denmark | Recruiting |
| Department of Gynaecology and Obstetrics | Randers, Denmark | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07429071