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โ† Trials
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Effectiveness of a Vaginal Gel on CIN1/2 Regression and HPV Clearance.

RecruitingNAAges 30 Years - 50 YearsFemaleUniversity of Aarhus
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In plain words

What the trial is, and whether it could suit you

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: โ€ข 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 (Papilocareยฎ) 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 an

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๐Ÿ“‹ Eligibility rules (as published)
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)
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What it tests

  • Papilocare Vaginal Gel
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Where

2 sites
Department of Gynaecology and Obstetrics
Horsens, Denmark
Department of Gynaecology and Obstetrics
Randers, Denmark
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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