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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Aug 2026 → Dec 2026
Primary endpoint removed 2 → 1 primary endpoints
See other at-risk trials from University of Aarhus

Record History

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  1. Primary endpoint(s) modifiedv3 Show 9 more changesShow less
    • Phase changed: Early Phase 1 → not applicable
    • Recruitment opened
    • Primary completion pushed from Aug 2026 to Dec 2026
    • Study completion pushed from Sep 2026 to Dec 2026
    • Study sites: 0 to 2
    • Start date changed from estimate of Mar 2026 to Jun 9, 2026
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints: 2 to 3
    • Study description shortened, about 603 words
  2. Secondary endpoints: details revised at 1 of 2 entriesv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07429071
Lead Sponsor University of Aarhus
Collaborators: Procare Health Iberia S.L.
Conditions
(from sponsor)		 Womens Health, Cervical Dysplasia, Cervical Intraepithelial Neoplasia (CIN), Non-invasive Treatment, Human Papilloma Virus (HPV)
Related terms Uterine Cervical Dysplasia
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov