ArticlePloS one2025
Phase I study on the pharmacokinetics of intravaginal, self-administered artesunate vaginal pessaries among women in Kenya.
Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
4 citing papers in PubMed.
- Heme as activator and target for artemisinin: Towards multiple pharmacological bioactivity.Biochemistry and biophysics reports · 2026Review
- Artemisinin and Its Derivatives from Molecular Mechanisms to Clinical Applications: New Horizons Beyond Antimalarials.International journal of molecular sciences · 2025Review
- Feasibility of Intravaginal Artesunate as an Adjuvant HPV & Cervical Precancer Treatment Among Women Living With HIV in Kenya: Study Protocol for a Phase II Clinical Trial.Cancer control : journal of the Moffitt Cancer CenterArticle
- Persistent human papillomavirus after thermal ablation in Malawian women with and without HIV: Implications for risk-based cervical cancer prevention in low- and middle-income countries.Women's health (London, England)Article
Corrections and comments
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Authors and funding
10 authors.
Funding
Abstract
objectivesThe primary objective of this study is to investigate the pharmacokinetics of Artesunate (AS) and its active metabolite, dihydroartemisinin (DHA) following intravaginal use at the dosing and frequency intended for cervical precancer treatment. A secondary objective is to assess safety among study participants.
methodsWe are conducting a single-arm, phase I trial with a sample size of 12 female volunteers. Participants will self-administer artesunate vaginal pessaries in the study clinic daily for 5 consecutive days. Participants will have their blood drawn prior to receiving the first dose of artesunate on day one of the study and then will receive 8 blood draws on study day five, prior to artesunate administration and at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours after pessary administration. Pharmacokinetic parameters of artesunate and DHA will be calculated by way of quantitative analysis of with determination of maximum concentration (Cmax), time to Cmax (Tmax), area under the serum concentration versus time curve (AUC), apparent clearance, and elimination half-life (t1/2).
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