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

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

May 29, 2024

Primary Completion Date

August 14, 2024

Study Completion Date

August 14, 2024

Conditions
Cervix CancerCervix Intraepithelial Neoplasia Grade 3Cervix; Intraepithelial Neoplasia, Grade ICervix; Intraepithelial Neoplasia, Grade II
Interventions
DRUG

Artesunate pessary

Subjects will use the study pessaries, placed in the vagina every day for 5 consecutive days.

DIAGNOSTIC_TEST

blood draws for pharmacokinetics of the study drug

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.

Trial Locations (1)

Unknown

Lumumba Sub-County Hospital, Kisumu

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

UNC Lineberger Comprehensive Cancer Center

OTHER

NCT06263582 - Pharmacokinetics of Intravaginal, Self-administered Artesunate Vaginal Pessaries Among Women in Kenya | Biotech Hunter | Biotech Hunter