Clinical trial · Interventional
Pharmacokinetics of Intravaginal, Self-administered Artesunate Vaginal Pessaries Among Women in Kenya
NCT06263582CI-TRIAL-00093845completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervix Cancer | — | UNRESOLVED | — |
| Cervix Intraepithelial Neoplasia Grade 3 | — | UNRESOLVED | — |
| Cervix; Intraepithelial Neoplasia, Grade I | Cervical Intraepithelial Neoplasia | ALIAS | 0.85 |
| Cervix; Intraepithelial Neoplasia, Grade II | Cervical Intraepithelial Neoplasia | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Artesunate pessary | Drug | — | UNRESOLVED |
| blood draws for pharmacokinetics of the study drug | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Artesunate vaginal inserts/ pessaries
- description
- Artesunate vaginal inserts/pessaries are used as a treatment for cervical precancerous lesions.
- interventionNames
- Drug: Artesunate pessary
- Diagnostic Test: blood draws for pharmacokinetics of the study drug
Primary outcomes (1)
- measure
- To Determine the Area Under the Plasma Concentration Versus Time Curve (AUC) of Dihydroartemisinin
- timeFrame
- Day 5
- description
- To determine the area under the plasma concentration versus time curve (AUC) of dihydroartemisinin (DHA) following five consecutive days of self-administration of 200mg Artesunate vaginal inserts (pessaries). Mean DHA AUC will be submitted.
Secondary outcomes (12)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria 1. Age 18 years or older 2. Negative pregnancy test at screening 3. Willingness to use contraception (hormonal or barrier) during the 5-day study dosing phase if of childbearing age (less than 50 years of age) 4. Ability and willingness to provide informed consent. Exclusion Criteria 1. Current pregnancy or breastfeeding status 2. History of total hysterectomy 3. Known allergy to Artesunate. 4. Have a medical comorbidity that in the opinion of the investigator would interfere with study participation. 5. Currently receiving artemisinin-based agents for malaria treatment or completed artemisinin-based treatment within the previous 3 days.
References
Publications (0)
Data not yet available
No reference posted for this study.