A Phase II double blind, placebo-controlled, randomized trial of artesunate vaginal inserts for the treatment of patients with cervical intraepithelial neoplasia (CIN2/3)

Primary Investigator

Harper, Diane

Status

OPEN TO ACCRUAL

Phase

NCT Number

NCT04098744

UM Number

2022.075

Age Group

Adults

Management Group

CTSU - Oncology

Oncology Group

Cancer Control and Prevention

ID (Protocol)

41456

Secondary Protocol No

HUM00223005

Scope

Unspecified

Sponsor Type

Industry

Disease Site

Cervix

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).

Eligibility: Inclusion 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
Exclusion Criteria
  •   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

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A Phase II double blind, placebo-controlled, randomized trial of artesunate vaginal inserts for the treatment of patients with cervical intraepithelial neoplasia (CIN2/3)