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A gel that may help the cervix heal from HPV lesions faces a test

NCT ID NCT04199078

Disease control Sponsor: Procare Health Iberia S.L. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests whether a vaginal gel called Papilocare can repair cervical lesions caused by high-risk human papillomavirus (HPV). Researchers plan to include 164 women aged 30 to 65 who have abnormal cervical cell results and test positive for high-risk HPV. Participants will be randomly assigned to one of four groups to compare different uses of the gel. The main goal is to see if the cervical lining heals after six months of treatment.

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, a gel applied inside the vagina with a single-dose applicator
What this could lead to
If it works, this gel could offer a non-surgical way to help the cervix heal from HPV-related lesions, potentially reducing the need for more invasive procedures.
What could go wrong
This is an early exploratory trial with a modest number of participants, so the gel may not prove effective. HPV lesions sometimes heal on their own, which could make it hard to tell if the gel is truly helping.

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

164 people

The number who actually took part.

Started

Sep 2019

Finished

Jun 2024

Lead sponsor

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

30 to 65 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: 1. Woman between the ages of 30 and 65 (both inclusive). 2. Able to read and understand the Patient Information Sheet and the Informed Consent form. 3. Acceptance in the participation of the essay and signature of the Informed Consent form. 4. ASC-US or LSIL or AG-US cytological result (maximum 3 months prior to inclusion) with concordant colposcopic image (performed at the screening visit). 5. High risk HPV positive by PCR performed at screening visit. 6. Is able, at the discretion of the researcher, to comply with the requirements of the trial and without hindrance to follow the instructions and assessments throughout it. Exclusion Criteria: 1. Clinically relevant immune system alterations, or any other autoimmune disease or in treatment with immunosuppressants. 2. Non-diagnosed abnormal genital hemorrhage (during the 6 months prior to the screening visit). 3. To had been vaccinated against HPV. 4. Other symptomatic vulvovaginal infections. 5. Surgical cervical excision in the last year or total hysterectomy. 6. Previous history of gynecological cancer. 7. Participation in any other clinical trial at present or in the 4 weeks prior to the inclusion of the trial. 8. Any planned surgery that prevents the correct compliance with the guidelines. 9. Use of vaginal contraceptives or other vaginal hormonal treatments. 10. Contraindications for the use of Papilocare® gel or known allergies to any of its components. 11. Women of childbearing age who do not use effective contraceptive methods, pregnant women, with suspicion of pregnancy or woman who are breastfeeding.

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Conditions

The condition(s) this trial relates to.

human papilloma virus infection

As listed by the trial registrant

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

Cervix lesion Human papilloma virus Human papilloma virus infection

Contacts and locations

Locations

  • Assir Hospitalet de Llobregat

    L'Hospitalet de Llobregat, 08904, Spain

  • Complejo Hospitalario Torrecárdenas

    Almería, 04009, Spain

  • H. General Universitario Santa Lucía

    Murcia, 30202, Spain

  • H. R. U. de Málaga / Materno Infantil

    Málaga, 29010, Spain

  • H. U. Reina Sofía

    Córdoba, 14004, Spain

  • Hospital General Universitario de Alicante

    Alicante, 03010, Spain

  • Hospital U. de Donostia

    Donostia / San Sebastian, Guipuzcoa, 20014, Spain

  • Hospital Universitari Son Espases

    Palma de Mallorca, Mallorca, 07120, Spain

  • Hospital Universitari Vall d' Hebron

    Barcelona, 08035, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario HM Puerta del Sur

    Móstoles, Madrid, 28938, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz de Tenerife, Tenerife, 38010, Spain

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014, Spain

  • Hospital Virgen de la Macarena

    Seville, 41009, Spain

  • Hospital de Basurto

    Bilbao, 48013, Spain

  • Hospital de Manacor

    Manacor, Spain

  • Hospital del Mar

    Barcelona, 08003, Spain

  • Hospital Álvaro Cunqueiro

    Vigo, 36312, Spain

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