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New treatment option for Human Papilloma Virus
Official title Study of 2LPAPI® on the Clearance of Genital HR-HPV Infections.
ClinicalTrials.gov ID: NCT04232917
What this study is testing
What is 2LPAPI®?
2LPAPI® is an investigational medicine, being studied as a potential treatment for human papilloma virus.
Also referred to as 2LPAPI.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 45, women only
You may be able to join if
- 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,
You likely can't join if
- 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,
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Belgium
- Charleroi, Belgium
- Malmedy, Belgium
- Namur, Belgium
- Ottignies, Belgium
- Tournai, Belgium
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, 25 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Belgium; Charleroi, Belgium; Malmedy, Belgium; Namur, Belgium; Ottignies, Belgium; Tournai, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.