CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 78 target
Drug / intervention
Artesunate vaginal insert +1 moredrug
Likely dose
Artesunate vaginal insert 200mgfrom record
Key inclusion· 6
  • ✓Adult females age ≥25 years
  • ✓Capable of informed consent
  • ✓Any HPV genotype detectable by DNA test/HPV genotyping
  • ✓Histologically confirmed cervical high grade squamous intraepithelial lesions (CIN2, CIN3, or CIN2/3)
Key exclusion· 7
  • ✕Pregnant and nursing women
  • ✕Active autoimmune disease
  • ✕Taking immunosuppressive medication
  • ✕HIV seropositivity

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04098744
NCT04098744Phase 2RecruitingOn TrackUpdated 8mo ago
Long Recruiting
CompareCT.gov

A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Vaginal Inserts for the Treatment of Patients With Cervical Intraepithelial Neoplasia (CIN2/3)

Frantz Viral Therapeutics, LLC·interventional·Posted Sep 23, 2019·Updated Oct 2, 2025

In Brief

A Phase 2 clinical trial evaluating Artesunate vaginal insert and Placebo vaginal insert for CIN 2/3 and 4 related conditions. Currently recruiting, targeting 78 participants across 7 sites.

Detailed Summary

This is a phase II double blind, placebo-controlled, randomized study of Artesunate vaginal inserts for the treatment of women who have cervical high grade intraepithelial neoplasia (CIN2/3).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCIN 2/3, HPV Infection, Pre-Cancerous Dysplasia, Cervical Dysplasia, HPV Related Disease
CountriesUnited States
CollaboratorsAmarex Clinical Research, M.D. Anderson Cancer Center, Harris Health System (L.B.J. Hospital), The Cleveland Clinic, University of Michigan, Florida Gynecologic Oncology

Timeline

Phase 2Recruiting
20202021202220232024202520262027
First PostedSep 23, 2019
Enrollment StartSep 9, 2020
Primary CompletionJul 31, 2026
Study CompletionDec 31, 2026
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 6.8 years agoPrimary completion in 29 days

Interventions

Artesunate vaginal insertdrug

Artesunate formulated as vaginal inserts, 200mg

Placebo vaginal insertdrug

Placebo for artesunate vaginal inserts