Authorised Therapeutic use (Phase IV) Human Papillomavirus infection

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

EU CTIS ID: 2024-513969-39-00

What this study is testing

Comparison of the efficacy of 2LPAPI® versus placebo on the clearance of genital HR-HPV infections after 12 months of follow-up.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • - Women between 25 and 45 years old; - 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, 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 for the duration of the study); - Patient having the ability to understand and respect the constraints of the study; - Signature of the Informed Consent Form.

You likely can't join if

  • - Pregnant or breastfeeding women; - 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 a total hysterectomy; - Patient under immunotherapy treatment (including immunosuppressive treatments) or micro-immunotherapy received in the last six months; - Patient with known lactose intolerance; - Patient who has participated in a clinical study in the last three months; - Patient not sufficiently motivated to engage in a 12-month follow-up, or likely to travel or move before the end of the study; - Patient with severe immune deficiency requiring long-term treatment (*) or under chemotherapy or radiotherapy; - Patient under listed homeopathic or phytotherapy treatment (see list in the protocol); - Patient using or addicted to recreational drugs. (*) important renal or respiratory failure,

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.