A Phase II, Randomized, Double-blind, Placebo-Controlled, Proof of Concept Study to Assess the Safety and Efficacy of Dysplasix™ Intravaginally-Administered Suppositories in Patients With High-Risk Human Papillomavirus (Hr-HPV) as Determined by HPV Testing, and Accompanied by Either (1) Atypical Squamous Cells of Undetermined Significance (ASC-US) or (2) Low-Grade Squamous Intraepithelial Lesions (LSIL), as Determined by Cytology
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
⁃ 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