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NCT04098744 · ClinicalTrials.gov registry record · Phase 2
Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)
A Phase 2 study of HPV Infection and Cervical Dysplasia, sponsored by Frantz Viral Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
- 7
- Study locations
NCT04098744: Recruiting Phase 2 study of HPV Infection and Cervical Dysplasia, sponsored by Frantz Viral Therapeutics.
NCT04098744 is a Phase 2 study of HPV Infection and Cervical Dysplasia that is actively recruiting participants, run by Frantz Viral Therapeutics. The registered enrollment target is 78 participants, below the 230-participant average among 13 other HPV Infection trials with a reported enrollment target (66% lower). The trial reports 7 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04098744, a Phase 2 study of HPV Infection and Cervical Dysplasia, is actively recruiting participants, sponsored by Frantz Viral Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
- 7
- Study locations
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).
Primary Outcome
Number of participants who undergo histologic regression to cervical intraepithelial neoplasia (CIN) 1 or less by week 17, following three 5-day cycles of artesunate vaginal inserts, as determined by the LEEP histopathologic analysis
Conditions Studied
Interventions
- DRUG Artesunate vaginal insert
- DRUG Placebo vaginal insert
Study Locations (7)
Ohio
- Cleveland Clinic Fairview Hospital - Cleveland
- Cleveland Clinic Foundation - Cleveland
- Hillcrest Hospital - Mayfield Heights
Texas
- The Harris Health System (L.B.J Hospital) - Houston
- University of Texas, M.D. Anderson - Houston
Florida
- Florida Gynecologic Oncology - Fort Myers
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2020-09-09 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What NCT04098744 shows while recruiting
NCT04098744 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 230-participant average among 13 other HPV Infection trials with a reported enrollment target (66% lower).
The record links to 5 conditions, with HPV Infection appearing as the primary indexed condition, and to 2 interventions - of which Artesunate vaginal insert is the first listed.
NCT04098744 lists 7 locations in 4 states (Ohio, Texas, Florida).
Frequently Asked Questions
What is clinical trial NCT04098744 about?
NCT04098744 is a clinical study titled "Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)". 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).
What is the current status of trial NCT04098744?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2020-09-09. Estimated completion is 2026-12-31.
What conditions does trial NCT04098744 study?
This clinical trial studies the following conditions: HPV Infection, Cervical Dysplasia, Pre-Cancerous Dysplasia, CIN 2/3, HPV Related Disease.
What interventions are being tested in trial NCT04098744?
The interventions under investigation include: Artesunate vaginal insert (DRUG), Placebo vaginal insert (DRUG).
Who is sponsoring clinical trial NCT04098744?
This trial is sponsored by Frantz Viral Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04098744 being conducted?
This trial has 7 study locations across Florida, Michigan, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HPV Infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04098744's enrollment target sits among peer trials
78 10th of 13 higher than 4 of 13 other HPV Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HPV Infection 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
-
Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)
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PopSci CHW4CervixHealth
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PCOM2 - The Physician Communication Intervention, Version 2.0
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-
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
RECRUITING · Phase 4
-
Evaluation of the Q-Pad hrHPV Test System for Identifying Precancer
RECRUITING · NA
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