Randomized, placebo-controlled, double-blind study to evaluate 2LPAPI® efficacy on the clearance of genital HR-HPV infections (PAPION study)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513969-39-00

Acronym

LLB-2017-01

Enrollment

484

Registered

2024-05-08

Start date

2024-05-09

Completion date

Unknown

Last updated

2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Papillomavirus infection

Brief summary

HR-HPV infection clearance at 12-month visit.

Detailed description

- HR-HPV infection clearance at 6-month visit; - HR-HPV infection clearance by HPV type at 6-month and 12-month visits; - Evolution of cytology (normalization, stagnation or aggravation) at 6-month and 12-month visits; - Normalization of cytology at 6-month and 12-month visits for the subpopulation of patients with a baseline non normal cytology, - Safety: adverse events (AEs) and serious adverse events (SAEs) considered as related or unrelated to the study drug.

Interventions

DRUG2LPAPI granules en gélules à ouvrir

DRUGPlacebo 2LPAPI

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
HR-HPV infection clearance at 12-month visit.	—

Secondary

Measure	Time frame
- HR-HPV infection clearance at 6-month visit; - HR-HPV infection clearance by HPV type at 6-month and 12-month visits; - Evolution of cytology (normalization, stagnation or aggravation) at 6-month and 12-month visits; - Normalization of cytology at 6-month and 12-month visits for the subpopulation of patients with a baseline non normal cytology, - Safety: adverse events (AEs) and serious adverse events (SAEs) considered as related or unrelated to the study drug.	—

Measure

Time frame

—

Countries

Belgium, Romania

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026