NCT06165614CompletedPhase 1
Artesunate Pessaries (Vaginal Inserts) for Cervical Precancer in Kenya
Self-administered Artesunate Pessaries for Treatment of Cervical Precancer in Kenya
Source: ClinicalTrials.gov · Last updated 19 Aug 2025
Brief summary (registry, in English)
To investigate the use of self-administered artesunate vaginal pessaries as treatment for cervical precancer in low and middle-income countries (LMIC). The central hypothesis of this study is that self-administered intravaginal Artesunate will be safe, and result in a clinical response among both HIV-positive and HIV-negative women with cervical precancer in LMICs.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- First submitted
- 21 Nov 2023
- Start date
- 4 Mar 2024
- Primary completion date
- 30 Jan 2025
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Diseases
- Cervical cancer
- NCT number
- NCT06165614
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 17
- From 4 Mar 2024 to the primary completion date, 30 Jan 2025
- 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 systemic chemotherapy or radiation therapy for another cancer
- Current use of systemic immunosuppressants or steroids (\>10 mg of prednisone or equivalent)
- Prior chemotherapy within 1 month prior to day 1 of study treatment
Other illness
- Current or past history of invasive cervical cancer.
- History of total hysterectomy.
Lab values
- CD4 count less than 200 cells/mm3.
Other
- Current pregnancy or breastfeeding status.
- Presence of adenocarcinoma in situ on cervical biopsy
- Have a medical comorbidity that in the opinion of the investigator would interfere with study participation.
- Male at birth
Who the study is looking for
- Cervical lesions referred for excision with CIN2/3 diagnosis on biopsy
- Weight ≥50 kg
- Agreement to use contraception (barriers or hormonal) through week 24 of the study if of childbearing age.
- Ability and willingness to provide informed consent.
Age in the registry: 18 years to - · Sex: Female · Does not accept 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 |
Related publications
- "When a Thorn Comes Into Your Body, You Must Remove It". A Socio-Ecological Analysis of the Acceptability of Intravaginal Artesunate as Cervical Precancer Treatment in a Phase 1 Clinical Trial.Int J Womens Health · 2026 · PMID 42403515
- Trying to Heal Without "Bringing Problems": Navigating Cervical Precancer Stigma in a Phase I Clinical Trial in Western Kenya.medRxiv · 2025 · PMID 41415498
This page is information, not medical advice. Discuss any trial with your doctor.