Artesunate Pessaries (Vaginal Inserts) for Cervical Precancer in Kenya

NCT06165614 | Completed Phase 1 DMC

• 1 other identifier: LCCC2236
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervix Cancer; Cervix Neoplasm; Precancerous Conditions; Cervical Precancer

Keywords

vaginal pessaries; artesunate

Outcome Measures

Primary Outcomes (1)

• the type, frequency, severity and duration of adverse events

  Safety will be assessed by evaluating the type, frequency, severity, and duration of adverse events (AEs) using the U.S National Cancer Institute Common Terminology Criteria for Adverse Events, v5.0 (CTCAE 5.0). The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology that can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.

  From the first day of the study treatment to week 14 ( 8 weeks after artesunate use)

Secondary Outcomes (4)

• Adherence

  From the first day of the study treatment to week 14 ( 8 weeks after artesunate use)

• Change in lesion

  From the first day of the study treatment to week 24

• Histologic regression

  From the first day of the study treatment to week 24

• Acceptability

  At week 8

Study Arms (1)

Artesunate vaginal inserts/ pessaries

EXPERIMENTAL

Artesunate vaginal inserts/pessaries are used as a treatment for cervical precancerous lesions.

Drug: Artesunate pessary; Procedure: Colposcopy

Interventions

Artesunate pessary DRUG

Subjects will self-administer 200 mg of Artesunate pessary (vaginal insert) daily for 5 days, on weeks 1, 3, 5, 7.

Artesunate vaginal inserts/ pessaries

Colposcopy PROCEDURE

Colposcopy is a procedure that allows close examination of the cervix, vagina, and vulva, performed on weeks 8 and 14.

Artesunate vaginal inserts/ pessaries

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Current pregnancy or breastfeeding status.
• Current or past history of invasive cervical cancer.
• History of total hysterectomy.
• CD4 count less than 200 cells/mm3.
• Presence of adenocarcinoma in situ on cervical biopsy
• Currently receiving systemic chemotherapy or radiation therapy for another cancer
• Current use of systemic immunosuppressants or steroids (\>10 mg of prednisone or equivalent)
• Have a medical comorbidity that in the opinion of the investigator would interfere with study participation.
• Prior chemotherapy within 1 month prior to day 1 of study treatment
• Male at birth

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Gilead Sciences: collaborator

Study Sites (1)

Lumumba Sub-County Hospital

Kisumu, Kenya

Location

Related Publications (1)

• Guliam A, Sadana A, Opiyo E, Adundo F, Sorgi K, Agha E, Mungo C. Trying to Heal Without "Bringing Problems": Navigating Cervical Precancer Stigma in a Phase I Clinical Trial in Western Kenya. medRxiv [Preprint]. 2025 Dec 17:2025.10.24.25338728. doi: 10.1101/2025.10.24.25338728.

  PMID: 41415498 DERIVED

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Precancerous Conditions; Uterine Cervical Dysplasia

Interventions

Colposcopy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Chemtai Mungo, MD, MPH, FACOG

  Lineberger Comprehensive Cancer Center, The University of North Carolina Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 11, 2023
• Study Start: March 4, 2024
• Primary Completion: January 30, 2025
• Study Completion: April 10, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)