Artesunate Vaginal Inserts for CIN2/3

This study is testing if artesunate vaginal inserts can help treat cervical intraepithelial neoplasia (CIN2/3), which are pre-cancerous changes in the cervix often caused by HPV (human papillomavirus) infection. You might be able to join if you are a woman aged 25 or older with a confirmed diagnosis of CIN2 or CIN3 and any type of HPV. The study aims to see how many participants show improvement in their cervical tissue by week 17. Participants will receive either artesunate vaginal inserts or a placebo (an inactive substance) for three cycles. The study is currently unclear on its recruitment status and plans to enroll 78 participants.

Study design
This is a phase II, double-blind study, meaning neither you nor your doctor will know if you are receiving artesunate or placebo. Participants are randomly assigned in a 2:1 ratio to receive either artesunate or placebo vaginal inserts.
What's involved
You would receive three 5-day cycles of vaginal inserts at weeks 0, 2, and 4. Dosing visits can be done via telehealth, with medication mailed to your home. You will have follow-up visits at weeks 6, 17, and 40, and all participants will undergo a LEEP procedure (a common treatment for CIN) at week 17.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed after receiving artesunate at weeks 6, 17, and 40.

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NCT04098744

Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)

Recruiting
PHASE2Ages 25+InterventionalTreatment
Frantz Viral Therapeutics, LLC
~78 participants
Updated 2025-10-02 on ClinicalTrials.gov
What's tested:Artesunate vaginal insertPlacebo vaginal insert

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants with histologic regression by week 17
Measured over 17 weeks
CIN 2/3
HPV Infection
Pre-Cancerous Dysplasia
Cervical Dysplasia
HPV Related Disease
7 sites across 4 states
Ohio3
Texas2
Florida1
Michigan1

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Eligibility criteria

Inclusion

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

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
  • Proportion of participants with histologic regression by week 1717 weeks

    Number of participants who undergo histologic regression to cervical intraepithelial neoplasia (CIN) 1 or less by week 17, following three 5-day cycles of artesunate vaginal inserts, as determined by the LEEP histopathologic analysis