A gel that could help the cervix heal from HPV?
NCT ID NCT07762209
First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This trial is testing whether a vaginal gel called Papilozumib, used alone or with an oral supplement, can help restore the cervical lining in women aged 30 to 50 who have an HPV infection. Participants will be randomly assigned to receive the gel, the gel plus supplement, or standard care, and will be followed for six months. The main goal is to see if the gel improves cervical tissue healing, with additional checks on HPV clearance and vaginal health.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Papilozumib vaginal gel, with or without an oral supplement containing mushroom extracts, vitamins, minerals, and probiotics
- What this could lead to
- If effective, this gel could offer a non-invasive way to help the cervix heal and potentially clear HPV, reducing the risk of cervical abnormalities.
- What could go wrong
- This is an early exploratory trial with a small number of participants, so results may not be conclusive. The gel's effect on HPV clearance is uncertain, and it may not work for everyone.
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
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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 81 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2027
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
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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30 to 50 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: * Female participant aged 30 to 50 years, inclusive. * Able to read and understand the participant information sheet and informed consent form. * Willing to participate and able to provide written informed consent. * Normal cervical cytology or cervical cytology showing atypical squamous cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), or atypical glandular cells (AGC), with corresponding colposcopic findings at baseline. * Cervical cytology obtained no more than 3 months before the baseline/randomization visit. * Positive test for human papillomavirus (HPV) by polymerase chain reaction (PCR) at baseline. * HPV PCR test obtained no more than 3 months before the baseline/randomization visit. * Exocervical mucosal restoration score of 3 or lower on the 5-point colposcopic scale at baseline. * Baseline colposcopy performed no more than 3 months before randomization; the score may be determined from previously recorded images when available in the medical record. * Considered by the investigator able to follow the study instructions, attend the required visits, and complete the study assessments. Exclusion Criteria: * Clinically relevant immune-system disorder, autoimmune disease, or current treatment with immunosuppressive medication. * Systemic or local treatment with antibiotics, antifungal agents, or another treatment that may alter the microbiota within 4 weeks before baseline/randomization. * Undiagnosed abnormal genital bleeding during the 6 months before screening. * Symptomatic vulvovaginal infection. * Surgical cervical excision within the previous year, cervical conization within the previous 6 months, or previous total hysterectomy. * Previous gynecological cancer. * Current participation in another clinical study or participation in another clinical study within 4 weeks before screening. * Planned surgery that could prevent adherence to the study treatment schedule. * Use of vaginal contraceptives or other vaginal hormonal treatments. * Contraindication to the vaginal gel or known allergy to any of its components. * Pregnant, suspected to be pregnant, breastfeeding, or of childbearing potential and not using an effective contraceptive method.
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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
6 sites. 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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Consulta Privada Miguel Ángel Rodríguez Zambrano
Majadahonda, Madrid, 28220, Spain
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Ginegetafe
Getafe, Madrid, 28901, Spain
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Hospital HM Montepríncipe
Boadilla del Monte, Madrid, 28660, Spain
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Hospital Quirónsalud Valle del Henares
Torrejón de Ardoz, Madrid, 28850, Spain
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Hospital Universitario Sanitas La Moraleja - Edificio Ana de Austria
Hortaleza, Madrid, 28050, Spain
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Instituto Palacios, Salud y Medicina de la Mujer
Madrid, Madrid, 28009, Spain
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- HPV infections in transgender people: a hidden health gap gets a closer look
- A Two-Pronged immune attack against HPV: could it prevent cervical cancer?
- Could fewer HPV vaccine doses offer lasting protection?
- Better swab, better catch: study aims to sharpen anal cancer screening