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

NCT07429071 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-08-03

No results posted yet for this study

Summary

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.

Conditions

  • Womens Health
  • Cervical Dysplasia
  • Cervical Intraepithelial Neoplasia (CIN)
  • Non-invasive Treatment
  • Human Papilloma Virus (HPV)

Interventions

COMBINATION_PRODUCT

Papilocare Vaginal Gel

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).

Sponsors & Collaborators

  • Procare Health Iberia S.L.

    collaborator INDUSTRY

  • University of Aarhus

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-09
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07429071 on ClinicalTrials.gov