CompletedPhase 1

Pharmacokinetics of Intravaginal, Self-administered Artesunate Vaginal Pessaries Among Women in Kenya

Kenya12 participantsStarted 2024-05-29

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexFEMALE

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Inclusion criteria

✓. Age 18 years or older
✓. Negative pregnancy test at screening
✓. Willingness to use contraception (hormonal or barrier) during the 5-day study dosing phase if of childbearing age (less than 50 years of age)
✓. Ability and willingness to provide informed consent.

Exclusion criteria

✕. Current pregnancy or breastfeeding status
✕. History of total hysterectomy
✕. Known allergy to Artesunate.
✕. Have a medical comorbidity that in the opinion of the investigator would interfere with study participation.
✕. Currently receiving artemisinin-based agents for malaria treatment or completed artemisinin-based treatment within the previous 3 days.

What they're measuring

To Determine the Area Under the Plasma Concentration Versus Time Curve (AUC) of Dihydroartemisinin

Timeframe: Day 5

Trial details

NCT IDNCT06263582

SponsorUNC Lineberger Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-14

Results submitted2025-07-31

View on ClinicalTrials.gov More Cervix Cancer trials