Phase II Study of Dysplasix™ Intravaginal Suppositories in Patients Patients With High-Risk HPV a… (NCT07572396) | Clinical Trial Compass
RecruitingPhase 2
Phase II Study of Dysplasix™ Intravaginal Suppositories in Patients Patients With High-Risk HPV and Mild Cervical Cytologic Abnormalities
Hong Kong45 participantsStarted 2026-04-30
Plain-language summary
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
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants capable of giving informed consent
. Females, ages 18 to 65 years old at the time of signature of the informed consent form.
. Participants who are able to correctly self-administer the intravaginal suppositories
. One or more hr-HPV oncotypes as confirmed by HPV test
. Participants with ASCUS or LSIL abnormalities as confirmed by cytology
. Immune competent
. Participants of childbearing potential must have a negative pregnancy test at screening.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine and evaluate the safety and tolerability of Dysplasix™ intravaginal suppository therapy in females with hr-HPV and positive cytology for either ASCUS or LSIL.
Timeframe: From enrollment until post-end of treatment follow up (Day 50 visit)
2
Regression of cervical cytology present at study entry
Timeframe: From enrollment to post-end of treatment follow-up (Day 50 visit)
3
Clearance of hr-HPV genotype present at study entry
Timeframe: From enrollment to post-end of treatment follow-up (Day 50 visit)