Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3) (NCT04098744) | Clinical Trial Compass
RecruitingPhase 2
Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)
United States78 participantsStarted 2020-09-09
Plain-language 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).
Who can participate
Age range25 Years – 100 Years
SexFEMALE
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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
What they're measuring
1
Proportion of participants with histologic regression by week 17