Dysplasix™ intravaginal suppositories for women with high‑risk HPV and mild cervical cell changes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II, double‑blind, randomized, placebo‑controlled study enrolls women with high‑risk HPV and cytology showing ASC‑US or LSIL. Enrolled participants self‑administer an intravaginal suppository nightly across a fifteen‑day course (three 5‑day cycles with two days off) and are randomized 1:1 to Dysplasix™ (EGCG + quinine sulfate) or matching placebo. Primary outcomes include regression of cervical cytologic abnormalities and clearance of hr‑HPV measured about 30 days after treatment, while safety and tolerability are tracked with participant diaries and clinic visits. Key exclusions include the presence of high‑grade lesions or glandular abnormalities, and participants must be able to attend clinic visits at the enrolling center.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Participants must meet all the following criteria to be eligible to enroll in the study:

1. Participants capable of giving informed consent
2. Females, ages 18 to 65 years old at the time of signature of the informed consent form.
3. Participants who are able to correctly self-administer the intravaginal suppositories
4. One or more hr-HPV oncotypes as confirmed by HPV test
5. Participants with ASCUS or LSIL abnormalities as confirmed by cytology
6. Immune competent
7. Participants of childbearing potential must have a negative pregnancy test at screening.
8. Participants of childbearing potential must agree to use appropriate contraception or abstain from sexual intercourse for the duration of the study
9. Participants must not have received a recent HPV vaccination and must abstain from HPV vaccination until the end of study

Exclusion Criteria:

Participants meeting any of the following criteria will be excluded from the study:

1. Presence of HSIL at screening cytology
2. Evidence of glandular abnormalities (AGC/AIS) at screening cytology
3. BMI below 16
4. Pregnant or nursing females
5. Evidence of vaginal/vulval comorbidities, specifically, common sexually transmitted or vaginal infections, and bloodborne pathogens
6. Using a vaginal contraceptive ring
7. History of irregular menstrual cycles or routine intermenstrual bleeding
8. Active autoimmune disease
9. Taking prohibited concomitant medications
10. Concurrent malignancy except for non-melanoma skin lesions
11. Active participation in another clinical trial involving therapeutic intervention (unless ending within 30 days of screening date)

Where it's running

• Prince of Wales Hospital
  Shatin, New Territories, Hong Kong Recruiting

Study contacts

• Principal investigator: Kar Kei Yung, MBBS (HK), MRCOG, FHKCOG, FHKA — Prince of Wales Hospital, Chinese University of Hong Kong
• Study coordinator: Trial Manager
• Email: p2trialhk@amplexd.com
• Phone: 713-933-9640

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• CHW4CervixHealth: HPV self-collection kits with community health workers

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• ALA-PDT for cervical LSIL with HPV16/18 in multiple centers

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• Q-Pad menstrual-pad test to detect high-risk HPV and cervical precancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.