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Could a simple gel replace surgery for HPV-Related cervical changes?

NCT ID NCT05509413

Disease control Sponsor: Ruhr University of Bochum Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a vaginal gel called DEFLAGYN, made from silica and citric acid, can help women with unclear cervical smears and high-risk HPV infections clear the virus and avoid surgery. 242 women used the gel for 3 months. The goal was to see if the gel increases the rate of HPV clearance and regression of abnormal cells compared to waiting without treatment.

What this could mean

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

Active substance
DEFLAGYN vaginal gel (silica and citric acid)
What this could lead to
If it works, this could offer a non-surgical, wait-and-see option for women with unclear cervical smears and high-risk HPV, potentially reducing the need for procedures like conization.
What could go wrong
This is a completed study with limited prior evidence. The gel is a medical device, not a drug, and its effect may be modest. Side effects were not observed in a prior small trial, but larger studies are needed to confirm benefits.

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

242 people

The number who actually took part.

Started

Nov 2022

Finished

Aug 2025

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

18 years and older

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: * Written consent * Unclear cervical smear (ASC-US, ASC-H, LSIL, HSIL or PAP II-p, PAP III-p, PAP IIID1, PAP IIID2 (Munich III) or PAP III, PAP IIID, PAP I + HPV high-risk infection) Exclusion Criteria: * Pregnancy * Known hypersensitivity to any of the ingredients of the vaginal gel * Insufficient knowledge of the German language * Pre-existing oncological diseases

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Conditions

The condition(s) this trial relates to.

cervical intraepithelial neoplasia dysplasia of cervix human papilloma virus infection

As listed by the trial registrant

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

Cervix, dysplasia HPV infection

Contacts and locations

Locations

  • Marien Hospital Herne

    Herne, North Rhine-Westphalia, 44625, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.