Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)
Part of paid clinical trials in Fort Myers, Florida.
- Sponsor
- Frantz Viral Therapeutics, LLC
- Study ID
- NCT04098744
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- CIN 2/3
- Cervical Dysplasia
- HPV Infection
- HPV Related Disease
- Pre-Cancerous Dysplasia
Eligibility Criteria
- Sex
- FEMALE
- Age
- 25 Years - 100 Years
- Healthy Volunteers
- Not accepted
Interventions
- Artesunate vaginal insert — DRUGArtesunate formulated as vaginal inserts, 200mg
- Placebo vaginal insert — DRUGPlacebo for artesunate vaginal inserts
Study Details
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).
Key Dates
- Start date
- Sep 9, 2020
- Status verified
- Sep 2025
- Primary completion
- Jul 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 78 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Artesunate vaginal insertParticipants will receive three 5-day cycles of artesunate vaginal inserts, 200mg/day, at week 0, week 2, week 4.
- Placebo Comparator: Placebo vaginal insertsParticipants will receive three 5-day cycles of placebo vaginal inserts, at week 0, week 2, and week 4.
Primary Outcome Measure
Proportion of participants with histologic regression by week 17 [ Time Frame: 17 weeks ]
Central Contacts
- Mihaela Plesa, BA, CCRP440-255-1155
- Ahmad Bayat, MD(301) 956-2523
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Florida Gynecologic Oncology | Fort Myers | Florida | 33905 | Fadi Abu Shahin, MD (PRINCIPAL_INVESTIGATOR) Samith Sandadi, MD (SUB_INVESTIGATOR) |
| University of Michigan | Ann Arbor | Michigan | 48109 | Diane Harper, MD (PRINCIPAL_INVESTIGATOR) |
| Cleveland Clinic Fairview Hospital | Cleveland | Ohio | 44111 | Chad Michener, MD (PRINCIPAL_INVESTIGATOR) Mariam AlHilli, MD (SUB_INVESTIGATOR) Steven Waggonner, MD (SUB_INVESTIGATOR) Robert DeBernardo, MD (SUB_INVESTIGATOR) Roberto Vargas, MD (SUB_INVESTIGATOR) |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | Chad Michener, MD (PRINCIPAL_INVESTIGATOR) Mariam AlHilli, MD (SUB_INVESTIGATOR) Steven Waggonner, MD (SUB_INVESTIGATOR) Robert DeBernardo, MD (SUB_INVESTIGATOR) Roberto Vargas, MD (SUB_INVESTIGATOR) |
| Hillcrest Hospital | Mayfield Heights | Ohio | 44124 | Chad Michener, MD (PRINCIPAL_INVESTIGATOR) Mariam AlHilli, MD (SUB_INVESTIGATOR) Steven Waggonner, MD (SUB_INVESTIGATOR) Robert DeBernardo, MD (SUB_INVESTIGATOR) Roberto Vargas, MD (SUB_INVESTIGATOR) Lindsey Beffa, MD (SUB_INVESTIGATOR) |
| The Harris Health System (L.B.J Hospital) | Houston | Texas | 77026 | Andrea Milbourne, MD (PRINCIPAL_INVESTIGATOR) Kathleen Schmeler, MD (SUB_INVESTIGATOR) |
| University of Texas, M.D. Anderson | Houston | Texas | 77030 | Andrea Milbourne, MD (PRINCIPAL_INVESTIGATOR) Kathleen Schmeler, MD (SUB_INVESTIGATOR) |
Find similar trials in Fort Myers, FL
Related Studies
- The Use of the LuViva Advanced Cervical Scan to Identify Women at High-Risk for Cervical NeoplasiaEnrolling By Invitation · Guided Therapeutics · Birmingham, Alabama
- Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical CancerRecruiting · Mayo Clinic · Phoenix, Arizona
- Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)PHASE4 · Recruiting · The University of Texas Medical Branch, Galveston · Galveston, Texas
- Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)PHASE2 · Recruiting · Frantz Viral Therapeutics, LLC · Fort Myers, Florida