Phase 1
Completed N=12
Pharmacokinetics of Intravaginal, Self-administered Artesunate Vaginal Pessaries Among Women in Kenya
Cervix Cancer · Cervix Intraepithelial Neoplasia Grade 3 · Cervix; Intraepithelial Neoplasia, Grade I · Cervix; Intraepithelial Neoplasia, Grade II
Source: ClinicalTrials.gov NCT06263582 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: To Determine the Area Under the Plasma Concentration Versus Time Curve (AUC) of Dihydroartemisinin — 464.90 ng/mL-h
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Determine the Area Under the Plasma Concentration Versus Time Curve (AUC) of Dihydroartemisinin |
464.90 | — |
| SECONDARY To Determine the Area Under the Plasma Concentration Versus Time Curve (AUC) of Artesunate (AS) |
504.21 | — |
| SECONDARY To Determine the Maximum Concentration of Artesunate (AS) |
83.74 | — |
| SECONDARY To Determine the Maximum Concentration of Dihydroartemisinin (DHA) (Cmax) |
97.00 | — |
| SECONDARY To Determine the Time to Maximum Concentration (Tmax) of Artesunate (AS) Following Five Consecutive Days |
4.17 | — |
| SECONDARY To Determine the Time to Maximum Concentration (Tmax) of Dihydroartemisinin (DHA |
6.33 | — |
| SECONDARY To Determine the Half-life (t1/2) of Artesunate (AS) |
— | — |
| SECONDARY To Determine the Half-life (t1/2) of Dihydroartemisinin (DHA) |
— | — |
| SECONDARY To Determine the Apparent Clearance (CL/F) of Artesunate (AS) |
— | — |
| SECONDARY To Determine the Apparent Clearance (CL/F) of Dihydroartemisinin (DHA) |
— | — |
| SECONDARY To Determine the Volume of Distribution (V/F) of Artesunate (AS) |
— | — |
| SECONDARY To Determine the Volume of Distribution (V/F) of Dihydroartemisinin (DHA) |
— | — |
| SECONDARY Type, Frequency, Severity, and Duration of Adverse Events |
3; 8; 1; 1; 1 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT06263582). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.