Vaginal Gel to Help HPV Clear and CIN Regress in Women with CIN1/2

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized study compares Papilocare Vaginal Gel against a wait-and-see approach over six months in women with hrHPV and CIN1 or CIN2. Participants are randomly assigned 1:1 to receive the gel daily for 21 days, then every other day for three months, with monthly breaks for menstruation, or to follow standard watchful waiting. Outcome assessments include hrHPV clearance at six months, CIN regression, vaginal microbiome changes, and patient-reported satisfaction and adherence. Outcome assessors are blinded to treatment allocation to reduce bias. The study is led by the University of Aarhus with international collaboration from Procare Health Iberia and conducted at multiple gynecology departments.

Why it matters

Who can join: the full rules

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)

Where it's running

• Department of Gynaecology and Obstetrics
  Horsens, Denmark Recruiting
• Department of Gynaecology and Obstetrics
  Randers, Denmark Recruiting

Study contacts

• Study coordinator: Pinar Bor, Professor, MD, Ph.D.
• Email: isipinbo@rm.dk
• Phone: 22504767

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.