Actively Recruiting
A Clinical Trial to Investigate the Safety and Efficacy of Papillex® on Abnormal Cervical Cells Caused by HPV.
Led by Papillex Inc. · Updated on 2026-03-05
60
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to investigate the safety and efficacy of Papillex® on the regression of abnormal cervical cells caused by HPV in women with a cervical intraepithelial neoplasia (CIN) 1 or 2 diagnosis. The main question it aims to answer is: Is there a difference in the proportion of participants with a regression in CIN based on histology or cytology from baseline at day 180 between Papillex® and placebo? Participants will be asked to consume Papillex® or placebo for 180 days, complete questionnaires, a PAP smear, HPV test, and colonoscopy (where applicable).
CONDITIONS
Official Title
A Clinical Trial to Investigate the Safety and Efficacy of Papillex® on Abnormal Cervical Cells Caused by HPV.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female between 25 and 55 years old
- Not of child-bearing potential due to permanent sterilization or post-menopausal for at least 1 year prior to screening, or if of child-bearing potential, negative pregnancy test and agreement to use approved birth control during the study
- Histologically confirmed CIN1 or CIN2 with high-risk HPV positivity and current abnormal cytology and HPV positivity
- Willing to provide copies of histology and/or cytology reports for eligibility confirmation
- Agree to maintain current lifestyle habits throughout the study
- Willing to avoid MRI, CT, X-ray, or contrast media procedures for 48 hours prior to study visits assessing micronutrient status
- Willing and able to complete questionnaires, diaries, clinic visits, and assessments
- Provide voluntary, written informed consent
- Otherwise healthy as determined by medical history and lab results assessed by Qualified Investigator
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy during the study
- Allergy, sensitivity, or intolerance to investigational product or placebo ingredients
- Currently undergoing treatment for CIN, indicated for treatment during study, treated for CIN within last 5 years, or active CIN3
- Concurrent uterine pathologies
- History of hysterectomy or destructive therapy of the cervix
- Cervical cancer
- Unstable metabolic or chronic diseases
- Significant gastrointestinal diseases
- Unstable hypertension or recent significant cardiovascular event
- Kidney or liver diseases except symptom-free kidney stones for 6 months
- Thyroid conditions unless stable on medication for 3 months
- Major surgery in past 3 months or planned surgery during study
- Cancer except fully excised skin basal cell carcinoma or cancer in remission over 5 years
- Autoimmune disease or immune compromise
- HIV, Hepatitis B or C infection
- Blood or bleeding disorders
- Alcohol intake over 2 standard drinks per day
- Alcohol or drug abuse within last 12 months
- Use of medications or supplements that may affect study product efficacy or safety
- Abnormal lab results at screening
- Blood donation within 30 days before baseline, during study, or planned before last visit
- Participation in other clinical trials within 30 days before baseline
- Cognitive impairment or inability to consent
- Any other condition or lifestyle factor that may affect study completion or pose risk as judged by Qualified Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
KGK Science Inc.
London, Ontario, Canada, N5Y 5V6
Actively Recruiting
Research Team
E
Erin Lewis, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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