NCT06979180

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

A Randomized, Triple-blind, Placebo-controlled, Parallel Clinical Trial to Investigate the Safety and Efficacy of Papillex® on Abnormal Cervical Cells Caused by HPV

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Papillex Inc. · Industry
• Sex: Female
• Age: 25 Years – 55 Years
• Healthy volunteers: Not accepted

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).

Conditions

• CIN - Cervical Intraepithelial Neoplasia
• CIN 1
• CIN 2
• HPV
• Cervical Cells

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Papillex®	Participants will be instructed to take two capsules twice daily with food, with the first dose taken with the first meal of the day and the second dose taken with the last meal of the day.
OTHER	Placebo	Participants will be instructed to take two capsules twice daily with food, with the first dose taken with the first meal of the day and the second dose taken with the last meal of the day.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-05-18
• Last updated: 2026-03-05

Locations

1 site across 1 country: Canada