Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Actively Recruiting
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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