Papilozumib Vaginal Gel for Exocervical Mucosal Restoration in Women With HPV (NCT07762209) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Papilozumib Vaginal Gel for Exocervical Mucosal Restoration in Women With HPV
Spain81 participantsStarted 2027-07
Plain-language summary
This randomized, open-label, multicenter clinical study is designed to evaluate Papilozumib® vaginal gel in women aged 30 to 50 years who test positive for human papillomavirus (HPV) and present with either normal cervical cytology or cytological findings of atypical squamous cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), or atypical glandular cells (AGC), accompanied by corresponding colposcopic findings.
Eighty-one participants will be randomly assigned in equal groups to receive either Papilozumib® vaginal gel, Papilozumib® vaginal gel plus an oral supplement, or standard clinical care without study treatment. All participants will be followed for six months.
The primary objective is to assess exocervical mucosa restoration 30 days after treatment initiation using a 5-point colposcopic scale. Additional assessments include cervical cytology, HPV clearance, vaginal health, treatment adherence, satisfaction, tolerability, safety, and exploratory analyses of the vaginal and intestinal microbiota.
Who can participate
Age range
30 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 a…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Exocervical mucosal restoration score at Day 30
Timeframe: Day 30 after treatment initiation
2
Participants with concordant cytology and colposcopy at Day 30