At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pharmacokinetics of Intravaginal, Self-administered Artesunate Vaginal Pessaries Among Women in Kenya
In Brief
A Phase 1 clinical trial evaluating Artesunate pessary and blood draws for pharmacokinetics of the study drug for Cervix Cancer and 3 related conditions. Completed, enrolled 12 participants across 1 site.
Detailed Summary
This study investigates the pharmacokinetics of Artesunate (AS) and dihydroartemisinin (DHA), the active metabolite of Artesunate, following intravaginal use at the dosing and frequency being studied for cervical precancer treatment. A secondary objective is to investigate safety among study participants.
Study Details
Timeline
Interventions
Subjects will use the study pessaries, placed in the vagina every day for 5 consecutive days.
On day 5, all participants will have their blood draws before they use the pessary, and at 15 min, 30 mins, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours after inserting the pessary. Blood samples will be tested for the pharmacokinetics of the study drug.