Using Artesunate Vaginal Inserts to Treat Cervical Pre-Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical trial evaluates the effectiveness of artesunate vaginal inserts in treating women with cervical high-grade intraepithelial neoplasia (CIN2/3). Participants are randomly assigned to receive either artesunate or a placebo over three 5-day cycles, with follow-up visits to assess treatment response and safety. The study includes telehealth options for dosing visits and requires participants to undergo a LEEP procedure at week 17 to evaluate histopathologic response. The primary goal is to determine the histopathologic response to the treatment, while secondary objectives focus on safety and viral clearance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult females age ≥ 25 years
* Capable of informed consent
* Any HPV genotype detectable by DNA test/HPV genotyping
* Colposcopically-directed, histologically confirmed tissue diagnosis of cervical high grade squamous intraepithelial lesions (CIN2, CIN3, or CIN2/3)
* Women of childbearing potential agree to use birth control through week17 of the study.
* Weight ≥ 50kg

Exclusion Criteria:

* Pregnant and nursing women
* Active autoimmune disease
* Taking immunosuppressive medication
* HIV seropositivity
* Immunocompromised subjects
* Evidence of concurrent cervical adenocarcinoma in situ
* Concurrent malignancy except for nonmelanoma skin lesions, because treatment for other cancers have systemic effects

Where it's running

• Florida Gynecologic Oncology
  Fort Myers, Florida, United States Recruiting
• University of Michigan
  Ann Arbor, Michigan, United States Recruiting
• Cleveland Clinic Fairview Hospital
  Cleveland, Ohio, United States Recruiting
• Cleveland Clinic Foundation
  Cleveland, Ohio, United States Recruiting
• Hillcrest Hospital
  Mayfield Heights, Ohio, United States Recruiting
• The Harris Health System (L.B.J Hospital)
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Mihaela Plesa, BA, CCRP
• Email: FVTinfo@frantzgroup.com
• Phone: 440-255-1155

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.