Endometrial Cancer Trial, Recruiting NCT06979180 Sponsor: Papillex Inc. Condition: Endometrial Cancer
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Endometrial Cancer Trial, Recruiting

NCT06979180
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Women between 25 and 55 years of age
  • Women who are not able to become pregnant — either because they have had a permanent sterilisation procedure (such as removal of the uterus or ovaries, or tubes being blocked) or have been through menopause for at least one year before screening
  • Women who could become pregnant may still be considered, provided a pregnancy test at the start of the study is negative and an approved method of contraception is used throughout — acceptable methods include hormonal contraceptives (such as the pill, patch, ring, injection, or implant, used for at least 3 months), double-barrier methods, intrauterine devices, a vasectomised sole partner with confirmed surgical success, abstinence, or a non-heterosexual lifestyle (or use of contraception if that changes)
  • People with a confirmed diagnosis of CIN1 or above (shown by tissue testing) along with a positive high-risk HPV test at that time, plus a current abnormal cervical screening result and positive HPV test at screening — with more than 12 months between the earlier diagnosis and screening (confirm with trial site for exact requirements)
  • Alternatively, people with documented abnormal cervical screening results (LSIL or worse) plus a positive HPV test more than 12 months ago, and a current abnormal result with positive HPV at screening
  • People willing to provide copies of their cervical testing reports for eligibility review
  • People willing to keep their usual lifestyle habits (diet, exercise, medications, supplements, and sleep) as consistent as possible throughout the study
  • People willing to avoid MRI, CT, X-ray, or procedures involving contrast dye for 48 hours before study visits that measure nutrient levels
  • People willing and able to fill in questionnaires and diaries, and to attend all required clinic visits
  • People who have voluntarily given written informed consent to take part
  • People who are otherwise in good health, as determined by their medical history and lab results reviewed by the trial's qualified investigator

Who may not be able to join:

  • Women who are pregnant, breastfeeding, or planning to become pregnant during the study
  • People with an allergy, sensitivity, or intolerance to any ingredient in the study product or placebo
  • People currently being treated for CIN, expected to need treatment during the study, who have had treatment (such as a cone biopsy or LEEP procedure) in the past five years, or who currently have CIN 3
  • People with other existing conditions affecting the uterus
  • People who have had a hysterectomy or destructive treatment to the cervix
  • People with cervical cancer
  • People with unstable metabolic conditions or ongoing chronic illness, as assessed by the trial's qualified investigator
  • People with a current or past significant condition affecting the digestive tract, as assessed by the qualified investigator
  • People with unstable high blood pressure (those on a stable medication dose for at least 3 months may be considered by the qualified investigator)
  • People who have had a significant heart or cardiovascular event in the past 6 months (those on stable medication with no significant event may be considered on a case-by-case basis)
  • People with a current or past kidney or liver condition, as assessed by the qualified investigator — though people with a history of kidney stones who have been symptom-free for 6 months may be considered
  • People with a self-reported current or pre-existing thyroid condition (those on a stable medication dose for at least 3 months may be considered by the qualified investigator)
  • People who have had major surgery in the past 3 months or who have planned surgery during the study (minor surgery cases may be considered individually by the qualified investigator)
  • People with a current cancer diagnosis, except for those with completely removed basal cell skin cancer with no further treatment needed and a clear follow-up, or those who have been in full cancer remission for more than five years
  • People with an autoimmune disease or a weakened immune system
  • People with a self-reported diagnosis of HIV, Hepatitis B, or Hepatitis C, as assessed by the qualified investigator
  • People with self-reported blood or bleeding disorders, as assessed by the qualified investigator
  • People who drink an average of more than 2 standard alcoholic drinks per day, as assessed by the qualified investigator
  • People with a history of alcohol or drug misuse in the past 12 months
  • People currently using certain prescription or over-the-counter medications, supplements, or foods or drinks that may affect how the study product works or its safety (confirm with trial site for specific details)
  • People with significantly abnormal laboratory results at screening, as assessed by the qualified investigator
  • People who have donated blood in the 30 days before the study starts, or who plan to donate blood within 30 days of the last study visit
  • People who have taken part in another clinical study within 30 days before the study starts
  • People who are unable to give informed consent or have cognitive impairment that would prevent participation
  • People with any other health condition or lifestyle factor that the qualified investigator believes could affect their ability to complete the study safely

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 14 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: David Crowley, MD, KGK Science Inc.

Phone: 1-226-242-4551

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Papillex Inc.
Registry
ClinicalTrials.gov
Start date
1 March 2026
Est. completion
1 December 2026

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

The difference in the proportion of participants with cytology improvement

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov