Recruiting

PAPIONRandomized, Placebo-controlled, Double-blind Study to Evaluate 2LPAPI® Efficacy on the Clearance of Genital HR-HPV Infections.

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What is being tested

2LPAPI®

+ Placebo

Drug
Who is being recruted

From 25 to 45 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: October 2020
See protocol details

Summary

Principal SponsorLabo'Life
Study ContactLaura FERTEMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 17, 2020

Actual date on which the first participant was enrolled.

The study duration will be 72 months with 60 months of inclusion (that may be extended if the expected number of patients is not reached after 60 months) and 12 months of follow-up. Patients aged between 25 and 45 years presenting a diagnosis of HR-HPV infection during the routine screening visit for cervical cancer prevention. The total number of patients to include will be 284 with 142 patients per group. Primary objective: Comparison of the efficacy of 2LPAPI® versus placebo on the clearance of genital HR-HPV infections after 12 months of follow-up. Secondary objectives: Comparison of 2LPAPI® versus placebo on: * HR-HPV infection clearance rate at 6-month visits, * HR-HPV infection clearance rate by HPV type at 6-month and 12-month visits, * Evolution of cytology, * Normalization of cytology for the subpopulation of patients with a baseline non normal cytology, * Safety: adverse events (AEs) and serious adverse events (SAEs), considered as related or not to the study drug. Treatment phase: Group n°1 = 2LPAPI® (6 months of treatment) Group n°2 = Placebo (6 months of treatment) Post-treatment follow-up phase: 6 months. Treatment will be considered successful if the clearance of HR-HPV is done and the cytology is normal.

Official TitleRandomized, Placebo-controlled, Double-blind Study to Evaluate 2LPAPI® Efficacy on the Clearance of Genital HR-HPV Infections.
NCT04232917
Principal SponsorLabo'Life
Study ContactLaura FERTEMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

284 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 25 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: * Women 25-45 years, * Women of childbearing age under effective contraception, * Patient with last cytology less than 3 years and normal or not more than LSIL or CIN I at the histology, * Patient with current cytology presenting normal, ASC-US, AGUS, LSIL, ASC-H, AGC or LSIL+ASC-H results or current diagnosis of CIN I at the histology, * Patient with HR-HPV diagnosis at the current cervical collection, * Patient reporting a current stable sexual relationship (steady sexual partner during study duration), * Patient having faculties to understand and respect the constraints of the study, * Signature of the Informed Consent Form. Exclusion Criteria: * Pregnant or breastfeeding woman, * Patient presenting HSIL diagnosis at the cytology or CIN II or CIN III diagnosis at the histology, * Patient having received HPV vaccination in the last month, * Patient previously subject to total hysterectomy, * Patient under immunotherapy (including immunosuppressive treatment) or micro-immunotherapy received during last previous 6 months, * Patient with known lactose intolerance, * Patient who participated in a clinical study in the previous 3-months' period, * Patient who is not sufficiently motivated to engage in a follow-up period of 12 months, or likely to travel or to move before the end of the study, * Patient with severe immunodeficiency disease requiring long term treatment (\*) or under chemotherapy or radiotherapy, * Patient under listed homeopathic or phytotherapy treatment (see protocol), * Patient using or addicted to recreational drugs. (\*) important renal or respiratory insufficiency, transplanted or grafted patients, HIV/AIDS, terminal cancer.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
The treatment schema consists in taking the content of one capsule a day, 15-30 minutes before breakfast, on an empty stomach, sequentially, according to capsules' numerical order: 1 through 10. When capsule number 10 is taken, capsule 1 of the next blister should be taken on the next day to continue the treatment. The duration of treatment will be 6 months of continuous intake of the content of 1 capsule/day.

Group II

Placebo
The treatment schema consists in taking the content of one capsule a day, 15-30 minutes before breakfast, on an empty stomach, sequentially, according to capsules' numerical order: 1 through 10. When capsule number 10 is taken, capsule 1 of the next blister should be taken on the next day to continue the treatment. The duration of treatment will be 6 months of continuous intake of the content of 1 capsule/day.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 12 locations

Recruiting

UCL Namur - site Sainte Elisabeth

Namur, BelgiumOpen UCL Namur - site Sainte Elisabeth in Google Maps
Recruiting

CHWAPI

Tournai, Belgium
Recruiting

CHU Saint-Pierre

Brussels, Belgium
Recruiting

Clinique St Jean

Brussels, Belgium
Recruiting
12 Study Centers