Study of 2LPAPI® on the Clearance of Genital HR-HPV Infections.

Launched by LABO'LIFE · Jan 16, 2020

Keywords

ClinConnect Summary

**Clinical Trial Summary: Study of 2LPAPI® on the Clearance of Genital HR-HPV Infections**

This clinical trial is investigating a treatment called 2LPAPI® to see how effective it is in helping women clear human papillomavirus (HPV) from their bodies. HPV is a common virus, and the trial focuses on high-risk types (HR-HPV) that can lead to health issues like cervical cancer. The study will involve women aged 25 to 45 who have been diagnosed with HR-HPV but have not shown severe abnormalities in their recent cervical tests. Participants will need to be using effective contraception and should have a steady sexual partner throughout the study.

If you decide to participate, you will receive either the 2LPAPI® treatment or a placebo (an inactive treatment) during the trial. The study will last for 12 months, and you will have regular follow-ups to check on your health and the effectiveness of the treatment. This trial is important because it could provide new options for managing HPV infections, especially for women who currently have limited treatment choices. If you're interested in joining, please be aware that there are some exclusions, such as being pregnant or having certain serious health conditions. It's essential to discuss this with your doctor to see if you qualify.

Gender

FEMALE

Eligibility 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.