A Clinical Trial to Investigate the Safety and Efficacy of Papillex® on Abnormal Cervical Cells C… (NCT06979180) | Clinical Trial Compass
RecruitingNot Applicable
A Clinical Trial to Investigate the Safety and Efficacy of Papillex® on Abnormal Cervical Cells Caused by HPV.
Canada60 participantsStarted 2026-03
Plain-language summary
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).
Who can participate
Age range25 Years – 55 Years
SexFEMALE
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Inclusion criteria
✓. Females between 25 and 55 years of age
✓. Females not of child-bearing potential, defined as those who have undergone a permanent sterilization procedure (e.g. hysterectomy, bilateral oophorectomy or bilateral tubal occlusion) or have been post-menopausal for at least 1 year prior to screening Or,
✓. Histologically confirmed CIN1+ (as per standard of care) with concordant hrHPV positivity at that time, and current abnormal cytology and hrHPV positivity at screening; interval between historical diagnosis and screening must be \>12 months OR documented abnormal cytology (LSIL or worse) plus hrHPV positive \>12 months prior, and current abnormal cytology with hrHPV positivity at screening
✓. Willing to provide copies of histology and/or cytology reports for eligibility confirmation
✓. Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study
✓. Willingness to avoid magnetic resonance imaging, computed tomography, X-ray, or other procedures with contrast media injection for 48 hr prior to study visits assessing micronutrient status
✓. Willingness and ability to complete questionnaires and diaries associated with the study, and to complete all clinic visits and assessments
What they're measuring
1
The difference in the proportion of participants with cytology improvement
. Provided voluntary, written, informed consent to participate in the study
Exclusion criteria
✕. Women who are pregnant, breast feeding, or planning to become pregnant during the study
✕. Allergy, sensitivity, or intolerance preventing consumption of investigational product or placebo ingredients
✕. Currently undergoing treatment for CIN, are indicated for treatment during the study period, have received treatment (e.g., conization or loop electrosurgical excision procedure) within the last five years, or have active CIN 3
✕. Concurrent uterine pathologies
✕. History of hysterectomy or destructive therapy of the cervix
✕. Cervical cancer
✕. Unstable metabolic disease or chronic diseases as assessed by the QI
✕. Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI