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NCT02354534 · ClinicalTrials.gov registry record · Phase 1

Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3)

A Phase 1 study of Cervical Intraepithelial Neoplasia Grade 2/3 and High-risk HPV (Any Strain), sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target
3
Study locations

NCT02354534 is a Phase 1 study of Cervical Intraepithelial Neoplasia Grade 2/3 and High-risk HPV (Any Strain) that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 30 participants. The trial reports 3 study locations across 1 state.

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The verdict

NCT02354534, a Phase 1 study of Cervical Intraepithelial Neoplasia Grade 2/3 and High-risk HPV (Any Strain), has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target
3
Study locations

Study 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.

Interventions

  • DRUG Artesunate Suppositories

Study Locations (3)

Maryland

  • Johns Hopkins Outpatient Center - Baltimore
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore
  • Greater Baltimore Medical Center - Towson

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2015-02
Est. Completion 2018-11-06
Phase Phase 1

What the Registry Record Tells You About NCT02354534

The ClinicalTrials.gov registry entry for NCT02354534 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Cervical Intraepithelial Neoplasia Grade 2/3 appearing as the primary indexed condition, and to 1 intervention - of which Artesunate Suppositories is the first listed.

NCT02354534 reports 3 study locations spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT02354534 about?

NCT02354534 is a clinical study titled "Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3)". 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 ...

What is the current status of trial NCT02354534?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2015-02. Estimated completion is 2018-11-06.

What conditions does trial NCT02354534 study?

This clinical trial studies the following conditions: Cervical Intraepithelial Neoplasia Grade 2/3, High-risk HPV (Any Strain).

What interventions are being tested in trial NCT02354534?

The interventions under investigation include: Artesunate Suppositories (DRUG).

Who is sponsoring clinical trial NCT02354534?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02354534 being conducted?

This trial has 3 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.