Actively Recruiting

Phase 2
Age: 18Years - 65Years
FEMALE
NCT07572396

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

Led by Amplexd Therapeutics, Inc. · Updated on 2026-05-14

45

Participants Needed

1

Research Sites

38 weeks

Total Duration

On this page

Sponsors

A

Amplexd Therapeutics, Inc.

Lead Sponsor

P

Prince of Wales Hospital, Shatin, Hong Kong

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to give informed consent
  • Female, aged 18 to 65 years at consent
  • Able to correctly self-administer intravaginal suppositories
  • Confirmed high-risk HPV infection by test
  • Confirmed ASC-US or LSIL cervical cytology abnormalities
  • Immune competent
  • Negative pregnancy test if of childbearing potential at screening
  • Agree to use contraception or abstain from sex during the study if of childbearing potential
  • No recent HPV vaccination and agree to avoid HPV vaccination until study end
Not Eligible

You will not qualify if you...

  • Presence of high-grade squamous intraepithelial lesion (HSIL) at screening cytology
  • Evidence of glandular abnormalities (AGC/AIS) at screening cytology
  • Body mass index (BMI) below 16
  • Pregnant or nursing females
  • Vaginal or vulval infections, sexually transmitted infections, or bloodborne pathogens
  • Using a vaginal contraceptive ring
  • History of irregular menstrual cycles or routine intermenstrual bleeding
  • Active autoimmune disease
  • Taking prohibited medications
  • Concurrent cancer except non-melanoma skin lesions
  • Currently participating in another therapeutic clinical trial (unless finished within 30 days before screening)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Actively Recruiting

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Research Team

T

Trial Manager

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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