HPV pill trial aims to clear precancerous cells without surgery
NCT ID NCT06979180
First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times
Summary
This study tests a supplement called Papillex® to see if it can help reverse abnormal cervical cells caused by HPV. Researchers will compare Papillex® to a placebo in 60 women with mild to moderate cervical changes (CIN 1 or 2). Participants take the supplement daily for 180 days and have follow-up Pap smears and HPV tests to check for improvement.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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25 to 55 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Females between 25 and 55 years of age 2. 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, Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include: * Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), hormone implant (Norplant System) or intrauterine hormone-releasing system * Double-barrier method * Intrauterine devices * Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s) * Vasectomized partner, provided that partner is the sole sexual partner and that the vasectomised partner has received medical assessment of the surgical success * Abstinence 3. 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 \>6 months OR documented abnormal cytology (LSIL or worse) plus hrHPV positive \>6 months prior, and current abnormal cytology with hrHPV positivity at screening 4. Willing to provide copies of histology and/or cytology reports for eligibility confirmation 5. Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study 6. 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 7. Willingness and ability to complete questionnaires and diaries associated with the study, and to complete all clinic visits and assessments 8. Provided voluntary, written, informed consent to participate in the study 9. Otherwise healthy as determined by medical history and laboratory results as assessed by Qualified Investigator (QI) Exclusion Criteria: 1. Women who are pregnant, breast feeding, or planning to become pregnant during the study 2. Allergy, sensitivity, or intolerance preventing consumption of investigational product or placebo ingredients 3. 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 4. Concurrent uterine pathologies 5. History of hysterectomy or destructive therapy of the cervix 6. Cervical cancer 7. Unstable metabolic disease or chronic diseases as assessed by the QI 8. Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI 9. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3) 10. Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis 11. History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months 12. Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI 13. Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI 14. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable 15. Individuals with an autoimmune disease or are immune compromised 16. Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI 17. Self-reported confirmation of blood/bleeding disorders as assessed by the QI 18. Alcohol intake average of \>2 standard drinks per day as assessed by the QI 19. Alcohol or drug abuse within the last 12 months 20. Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy and/or safety of the investigational product (Section 7.3) 21. Clinically significant abnormal laboratory results at screening as assessed by the QI 22. Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit 23. Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI 24. Individuals who are cognitively impaired and/or who are unable to give informed consent 25. Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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KGK Science Inc.
RECRUITINGLondon, Ontario, N5Y 5V6, Canada
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Other studies related to the condition(s) this trial covers.
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- Pocket-sized HIV test could bring same-day diagnosis to community clinics