A Clinical Trial to Investigate the Safety and Efficacy of Papillex® on Abnormal Cervical Cells Caused by HPV.

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).

Trial Details

NCT ID
NCT06979180
Phase
NA
Sponsor
Papillex Inc.
Status
RECRUITING
Cancer Type
Cervical Cancer
Interventions
  • Papillex®
  • Placebo
Locations (sample)
  • London, Ontario, Canada|42.98339,-81.23304

Key Eligibility 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 oopho…
  • Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth con…
  • Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable …

For full eligibility, visit ClinicalTrials.gov.

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