What this study is
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's being tested
- Artesunate vaginal insert
Intervention · DRUG
Artesunate formulated as vaginal inserts, 200mg
- Placebo vaginal insert
Intervention · DRUG
Placebo for artesunate vaginal inserts
Study details
- Official title
- A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Vaginal Inserts for the Treatment of Patients With Cervical Intraepithelial Neoplasia (CIN2/3)
- Sponsor
- Frantz Viral Therapeutics, LLC
- Conditions
- CIN 2/3 · HPV Infection · Pre-Cancerous Dysplasia · Cervical Dysplasia · HPV Related Disease
- Enrolling
- 78 people
- Starts
- 2020-09-09
- Est. completion
- 2026-12-31
- Design
- Double-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 25 Years – 100 YearsSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- Adult females age ≥ 25 years
- Capable of informed consent
- Any HPV genotype detectable by DNA test/HPV genotyping
- Colposcopically-directed, histologically confirmed tissue diagnosis of cervical high grade squamous intraepithelial lesions (CIN2, CIN3, or CIN2/3)
- Women of childbearing potential agree to use birth control through week17 of the study.
- Weight ≥ 50kg
You can't join if
- Pregnant and nursing women
- Active autoimmune disease
- Taking immunosuppressive medication
- HIV seropositivity
- Immunocompromised subjects
- Evidence of concurrent cervical adenocarcinoma in situ
- Concurrent malignancy except for nonmelanoma skin lesions, because treatment for other cancers have systemic effects
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (7)
7 openFlorida Gynecologic Oncology
Fort Myers, Florida, United States
- Cami Hansen · Contact239-334-6626cami.hansen25@gmail.com
- Fadi Abu Shahin, MD · Principal investigator
- Samith Sandadi, MD · Sub-investigator
RecruitingUniversity of Michigan
Ann Arbor, Michigan, United States
- Mubeenah Syedah · Contact734-998-6349symubeen@med.umich.edu
- Diane Harper, MD · Principal investigator
RecruitingCleveland Clinic Fairview Hospital
Cleveland, Ohio, United States
- Donna White · Contact216-445-8090whited11@ccf.org
- Megan Park · Contact216-445-8090parkm2@ccf.org
- 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
RecruitingCleveland Clinic Foundation
Cleveland, Ohio, United States
- Donna White · Contact216-445-8090whited11@ccf.org
- Megan Park · Contact216-445-8090parkm2@ccf.org
- 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
RecruitingHillcrest Hospital
Mayfield Heights, Ohio, United States
- Donna White · Contact216-445-8090whited11@ccf.org
- Megan Park · Contact216-445-8090parkm2@ccf.org
- 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
RecruitingThe Harris Health System (L.B.J Hospital)
Houston, Texas, United States
- Jessica Gallegos · Contact713-563-4580jrgalleg@mdanderson.org
- Cindy Melendez · Contact713-563-4582cvmelend@mdanderson.org
- Andrea Milbourne, MD · Principal investigator
- Kathleen Schmeler, MD · Sub-investigator
RecruitingUniversity of Texas, M.D. Anderson
Houston, Texas, United States
- Jessica Gallegos · Contact713-563-4580jrgalleg@mdanderson.org
- Cindy Melendez · Contact713-563-4582cvmelend@mdanderson.org
- Andrea Milbourne, MD · Principal investigator
- Kathleen Schmeler, MD · Sub-investigator
Recruiting
Study team
Sponsor
Frantz Viral Therapeutics, LLC
Study ID ART-CIN IIB
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.