Phase II Study of Dysplasix™ Intravaginal Suppositories in Patients Patients With High-Risk HPV and Mild Cervical Cytologic Abnormalities
Recruiting
Phase 2
Interventional Study
High-risk HPV (Any Strain)
LSIL, Low Grade Squamous Intraepithelial Lesion
ASC-US
HPV Infection
Cervical Abnormalities
Uterine Cervical Dysplasia
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 45 (estimated)
- Sponsor
- Amplexd Therapeutics, Inc. · Industry
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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 t…
Trial Locations
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Eligibility Criteria
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-…
Contacts