NCT06263582CompletedPhase 1
Pharmacokinetics of Intravaginal, Self-administered Artesunate Vaginal Pessaries Among Women in Kenya
Source: ClinicalTrials.gov · Last updated 19 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 8 Feb 2024
- Start date
- 29 May 2024
- Primary completion date
- 14 Aug 2024
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Diseases
- Cervical cancer
- NCT number
- NCT06263582
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 12
- From 29 May 2024 to the primary completion date, 14 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving artemisinin-based agents for malaria treatment or completed artemisinin-based treatment within the previous 3 days.
Other illness
- History of total hysterectomy
- Known allergy to Artesunate.
Other
- Current pregnancy or breastfeeding status
- Have a medical comorbidity that in the opinion of the investigator would interfere with study participation.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lumumba Sub-County Hospital Coordinator of this site? Confirm its status | Kisumu | Kenya | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.