Study of 2LPAPI® on the Clearance of Genital HR-HPV Infections.
ConditionHuman Papilloma Virus
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age25-45
SponsorLabo'Life
About this trial
Human papillomavirus (HPV) is a prevalent pathogen, the epidemiology of which has mostly been studied in the uterine cervix and the vagina.
The KCE Report 238Cs (2015) recommends " HR-HPV-positive women should not be offered colposcopy immediately. Triage should be done using cytology for this purpose. If cytological abnormalities (ASCUS+) are found, immediate referral should follow for diagnosis and, where appropriate, treatment. If no abnormalities are observed in triage, the subject should be offered follow-up testing (cytology) at six months. ".
There is no treatment that is recommended during this lap time. The 2LPAPI® has been available for more than 20 years, and has received a marketing authorization in Belgium by the FAMHP. It is used as an immune regulator in the treatment of HR-HPV infections. Since 2LPAPI® has been made available, clinical observational data collected on treated patients have shown the beneficial effect on the clearance of HPV.
The purpose of this placebo-controlled trial is to evaluate the efficacy of 2LPAPI® on the clearance of genital HR-HPV infections.
Eligibility criteria
Qualifiers
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,
Disqualifiers
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,
Trial design
Treatments tested in this trial
- 2LPAPI®
- Placebo
Treatment groups
284 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov