Clinical Trial

A Clinical Trial to Investigate the Safety and Efficacy of Papillex® on Abnormal Cervical Cells Caused by HPV.

Recruiting
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Summary
The goal of this clinical trial is to investigate the safety and efficacy of Papillex® on the regression of abnormal cervical cells caused by HPV in women with a cervical intraepithelial neoplasia (CIN) 1 or 2 diagnosis. The main question it aims to answer is: Is there a difference in the proportion of participants with a regression in CIN based on histology or cytology from baseline at day 180 between Papillex® and placebo? Participants will be asked to consume Papillex® or placebo for 180 days, complete questionnaires, a PAP smear, HPV test, and colonoscopy (where applicable).
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2025-05-12; most recent amendment 2026-07-06.
Status change: Not Yet Recruiting → Recruiting 2025-07-08
Trial Details
NCT Number NCT06979180
Lead Sponsor Papillex Inc.
Conditions CIN - Cervical Intraepithelial Neoplasia, CIN 1, CIN 2, HPV, Cervical Cells
Enrollment 60 participants
Start Date 2026-03-01
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-08