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Papilozumib Vaginal Gel for Exocervical Mucosal Restoration in Women With HPV

NCT07762209 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2026-08-13

No results posted yet for this study

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.

Conditions

  • Human Papillomavirus Infection
  • Human Papillomavirus Infections

Interventions

DEVICE

Papilozumib vaginal gel

Papilozumib® is a single-dose vaginal gel administered for 6 months. During the first 3 months, participants apply one vaginal applicator daily for 21 days followed by 7 days without treatment. During the following 3 months, participants apply one applicator on alternate days, excluding menstrual periods.

DIETARY_SUPPLEMENT

Papilozumib oral supplement

Papilozumib® oral supplement is provided as capsules containing mushroom extracts, vitamins, minerals, and probiotics. Participants take three capsules daily for 6 months: two capsules while fasting and one capsule before dinner, separated from meals.

Sponsors & Collaborators

  • Adknoma Health Research

    collaborator INDUSTRY

  • Eurofins

    collaborator INDUSTRY

  • Hifas da Terra S.L.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-07-31
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07762209 on ClinicalTrials.gov