CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
Artesunate Suppositoriesdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT02354534
NCT02354534Phase 1Completed

A Phase I Study of Intravaginally Administered Artesunate In Women With High Grade Cervical Intraepithelial Neoplasia (CIN2/3)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Feb 3, 2015·Updated Apr 28, 2021

In Brief

A Phase 1 clinical trial evaluating Artesunate Suppositories for Cervical Intraepithelial Neoplasia Grade 2/3 and High-risk HPV (Any Strain). Completed, enrolled 30 participants across 3 sites.

Detailed Summary

This phase I research protocol is designed to assess immunogenicity and clinical endpoints in patients with human papillomavirus (HPV) 16 cervical intraepithelial neoplasia (CIN)2/3. The protocol tests the use of artesunate in suppository formulation applied intravaginally in patients with cervical dysplasia (CIN2/3). The primary endpoint is to determine and evaluate the safety, tolerability, and feasibility of intravaginal administration of artesunate in health women with CIN2/3.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 3, 2015
Enrollment StartFeb 1, 2015
Primary CompletionJul 1, 2018
Study CompletionNov 6, 2018
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 11.4 years ago

Interventions

Artesunate Suppositoriesdrug