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

NCT04098744 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2025-10-02

No results posted yet for this study

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).

Conditions

  • CIN 2/3
  • HPV Infection
  • Pre-Cancerous Dysplasia
  • Cervical Dysplasia
  • HPV Related Disease

Interventions

DRUG

Artesunate vaginal insert

Artesunate formulated as vaginal inserts, 200mg

DRUG

Placebo vaginal insert

Placebo for artesunate vaginal inserts

Sponsors & Collaborators

  • Amarex Clinical Research

    collaborator OTHER

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Harris Health System (L.B.J. Hospital)

    collaborator UNKNOWN

  • The Cleveland Clinic

    collaborator OTHER

  • University of Michigan

    collaborator OTHER

  • Florida Gynecologic Oncology

    collaborator UNKNOWN

  • Frantz Viral Therapeutics, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-09
Primary Completion
2026-07-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04098744 on ClinicalTrials.gov