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Phase II Study of Dysplasix™ Intravaginal Suppositories in Patients Patients With High-Risk HPV and Mild Cervical Cytologic Abnormalities

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Minor Eligibility criteria shortened, about 6 wordsv4
  2. Minor Re-verified, no change to tracked fieldsv3
  3. Minor Study title shortened, about 6 wordsv2
  4. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this clinical trial is to learn if an investigational vaginal suppository therapy works to treat low-grade cervical lesions (ASC-US and LSIL) associated with high-risk human papillomavirus (hr-HPV) infection in women. It will also learn about the safety and tolerability of this investigational therapy. The main questions it aims to answer are: * Does the investigational therapy lead to regression of cervical lesions? * Does the investigational therapy help clear hr-HPV infection? * Do any adverse effects occur from using this medical product? Researchers will compare the investigational therapy to a placebo (a look-alike substance that contains no active drug) to see if the investigational therapy works. Participants will: * Be screened for hr-HPV, cervical abnormalities, and other conditions to be assessed for eligibility * Self-administer 15 doses of the investigational therapy or placebo as a vaginal suppository over 19 calendar days * Attend scheduled clinic visits for examinations, testing, and monitoring for a period of two months * Undergo assessments to evaluate cervical lesion status, hr-HPV infection, and safety outcomes * Keep a daily diary of investigational therapy use and associated information
Trial Details
NCT Number NCT07572396
Lead Sponsor Amplexd Therapeutics, Inc.
Collaborators: Prince of Wales Hospital, Shatin, Hong Kong, Chinese University of Hong Kong
Conditions
(from sponsor)
High-risk HPV (Any Strain), LSIL, Low Grade Squamous Intraepithelial Lesion, ASC-US, HPV Infection, Cervical Abnormalities, Uterine Cervical Dysplasia
Related terms Atypical Squamous Cells of the Cervix, Papillomavirus Infections, Squamous Intraepithelial Lesions, Uterine Cervical Dysplasia
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov