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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: High-risk HPV (Any Strain), LSIL, Low Grade Squamous Intraepithelial Lesion, ASC-US, HPV Infection, Cervical Abnormalities, Uterine Cervical Dysplasia

In brief

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

Key facts

Study ID

NCT07572396

Run by

Amplexd Therapeutics, Inc.

People needed

45

Starts

2026-04-30

Expected to finish

2027-01-27

Last updated by the study team

2026-05-14

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Participants must meet all the following criteria to be eligible to enroll in the study:
• 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.
• Participants of childbearing potential must agree to use appropriate contraception or abstain from sexual intercourse for the duration of the study
• Participants must not have received a recent HPV vaccination and must abstain from HPV vaccination until the end of study

You may not qualify if…

• Participants meeting any of the following criteria will be excluded from the study:
• Presence of HSIL at screening cytology
• Evidence of glandular abnormalities (AGC/AIS) at screening cytology
• BMI below 16
• Pregnant or nursing females
• Evidence of vaginal/vulval comorbidities, specifically, common sexually transmitted or vaginal infections, and bloodborne pathogens
• Using a vaginal contraceptive ring
• History of irregular menstrual cycles or routine intermenstrual bleeding
• Active autoimmune disease
• Taking prohibited concomitant medications
• Concurrent malignancy except for non-melanoma skin lesions
• Active participation in another clinical trial involving therapeutic intervention (unless ending within 30 days of screening date)

Where it is running

• Prince of Wales Hospital — Shatin, New Territories, Hong Kong (enrolling)

Full record on ClinicalTrials.gov

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