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Could a vaginal suppository clear High-Risk HPV?

NCT ID NCT07572396

Disease control Sponsor: Amplexd Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether a vaginal suppository called Dysplasix can help women clear high-risk human papillomavirus (HPV) and reverse low-grade cervical abnormalities. About 45 women with HPV and mild cervical changes will use the suppository or a placebo for 19 days. Researchers will check if the lesions shrink and if the virus clears, while monitoring safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Epigallocatechin gallate and quinine sulfate vaginal suppository
What this could lead to
If it works, this could offer a non-surgical treatment option to clear high-risk HPV and reverse early cervical changes, potentially reducing the need for procedures.
What could go wrong
This is a small, early-phase trial with only 45 participants, so results may not apply to everyone. The treatment may not work better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

Atypical Squamous Cells of the Cervix cervical intraepithelial neoplasia cervical squamous intraepithelial neoplasia dysplasia of cervix human papilloma virus infection squamous cell intraepithelial neoplasia Squamous Intraepithelial Lesions

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asc-us Cervical abnormalities High-risk HPV (any strain) HPV infection Lsil, low grade squamous intraepithelial lesion Uterine cervical dysplasia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Prince of Wales Hospital

    RECRUITING

    Shatin, New Territories, Hong Kong

    Contact Email: •••••@•••••

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