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Could a vaginal gel replace surgery for cervical dysplasia?

NCT ID NCT07429071

Disease control Sponsor: University of Aarhus Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 04, 2026 · Updated 4 times

Summary

This early-stage trial tests whether a mushroom-based vaginal gel (Papilocare) can help clear HPV and reverse mild to moderate cervical dysplasia (CIN1/CIN2). Seventy women aged 30-50 will either use the gel for 6 months or follow the standard 'watch and wait' approach. The study aims to see if the gel leads to better outcomes without invasive procedures.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Papilocare vaginal gel (Coriolus versicolor-based)
What this could lead to
If it works, this could offer a non-invasive treatment option for early cervical dysplasia and help clear HPV, reducing the need for surgery.
What could go wrong
This is a very early, small trial (70 women) with no results yet. The gel may not work better than watchful waiting, and long-term effects are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 50 years

Sex

Female participants only

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * Aged 30-50 years * A positive hrHPV test with histopathological confirmed CIN1 or CIN2 * Managed under a 'watchful waiting' strategy as part of standard management * Understand Danish, both written and orally Exclusion criteria: * Pregnancy or breastfeeding * Unexplained vaginal bleeding * Immunosuppressive or immunomodulatory conditions or treatment * Diabetes mellitus * Prior hysterectomy * Any ongoing cancer diagnosis, prior CIN3 or a history of malignancy in the genital/anal region within 5 years (excl. non-melanoma skin cancer)

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Conditions

The condition(s) this trial relates to.

cervical intraepithelial neoplasia cervical intraepithelial neoplasia grade 2/3 dysplasia of cervix human papilloma virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical dysplasia Cervical intraepithelial neoplasia (CIN) Human papilloma virus (HPV) Non-invasive treatment Womens health

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Department of Gynaecology and Obstetrics

    RECRUITING

    Horsens, 8700, Denmark

  • Department of Gynaecology and Obstetrics

    RECRUITING

    Randers, Denmark

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