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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorAmplexd Therapeutics, Inc.

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

Presence of HSIL at screening cytology

Evidence of glandular abnormalities (AGC/AIS) at screening cytology

BMI below 16

Pregnant or nursing females

Trial design

Treatments tested in this trial

  • EGCG and Quinine Sulfate Vaginal Suppository
  • Placebo

Treatment groups

45 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Amplexd Therapeutics, Inc.

Lead sponsor

Prince of Wales Hospital, Shatin, Hong Kong

Collaborator

Chinese University of Hong Kong

Collaborator