RecruitingNot applicableFemale onlyEN originalCervical cancer

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

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek 30-50 lat
  • Pozytywny test na HPV z potwierdzonym przedrakowymizmianami szyjki macicy (stadium 1 lub 2)
  • Kwalifikuje się do obserwacyjnego leczenia bez interwencji
  • Rozumiesz język duński pisany i mówiony

✗ Disqualifies

  • Jesteś w ciąży lub karmiąc piersią
  • Nienormalne krwawienia z pochwy
  • Osłabiona lub zaburzona odporność
  • Cukrzyca
  • Usunięta macica w przeszłości
  • Aktualny nowotwór lub historia zmian zaawansowanych w okolicy genitalnej w ciągu 5 lat

Simplified criteria — AI translation

Trial details

Minimum age
30 Years
Maximum age
50 Years
Last updated (source)
August 3, 2026
Sex
Female only

Therapies / drugs in trial

Locations (2)

Department of Gynaecology and Obstetrics

Horsens, Denmark

Department of Gynaecology and Obstetrics

Randers, Denmark

Trial contact

Pinar Bor, Professor, MD, Ph.D.

Vibe M Bertelsen, Post.Doc, MD, Ph.D.

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/4/2026.

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