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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: Completed 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.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of participants with serious adverse events or dose limiting toxicities related to the study intervention assessed using Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2015-02 |
| Est. Completion | 2018-11-06 |
| Phase | Phase 1 |
What the finished NCT02354534 record still lists
NCT02354534 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT02354534's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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