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Papilozumib Vaginal Gel for Exocervical Mucosal Restoration in Women With Human Papillomavirus (HPV)

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 11 of 11 entries
    • Study description shortened, about 1 word
    • Study title expanded, about 2 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07762209
Lead Sponsor Hifas da Terra S.L.
Collaborators: Adknoma Health Research, Eurofins
Conditions
(from sponsor)		 Human Papillomavirus Infection, Human Papillomavirus Infections
Related terms Atypical Squamous Cells of the Cervix, Papillomavirus Infections, Squamous Intraepithelial Lesions
Enrollment 81 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov