RECRUITING

Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)

Description

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).

Conditions

CIN 2/3HPV InfectionPre-Cancerous DysplasiaCervical DysplasiaHPV Related Disease
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Related Conditions:

CIN 2/3HPV InfectionPre-Cancerous DysplasiaCervical DysplasiaHPV Related Disease

Study Overview

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Study Details

Study overview

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).

A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Vaginal Inserts for the Treatment of Patients With Cervical Intraepithelial Neoplasia (CIN2/3)

Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)

Condition
CIN 2/3
Intervention / Treatment

-

Contacts and Locations

Fort Myers

Florida Gynecologic Oncology, Fort Myers, Florida, United States, 33905

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Cleveland

Cleveland Clinic Fairview Hospital, Cleveland, Ohio, United States, 44111

Cleveland

Cleveland Clinic Foundation, Cleveland, Ohio, United States, 44195

Mayfield Heights

Hillcrest Hospital, Mayfield Heights, Ohio, United States, 44124

Houston

The Harris Health System (L.B.J Hospital), Houston, Texas, United States, 77026

Houston

University of Texas, M.D. Anderson, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

25 Years to 100 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Frantz Viral Therapeutics, LLC,

Study Record Dates

2025-12-31