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Artesunate Pessaries (Vaginal Inserts) for Cervical Precancer in Kenya

NCT06165614 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-08-19

No results posted yet for this study

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

Interventions

DRUG

Artesunate pessary

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

PROCEDURE

Colposcopy

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

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Chemtai Mungo, MD, MPH, FACOG · Lineberger Comprehensive Cancer Center, The University of North Carolina Chapel Hill

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-04
Primary Completion
2025-01-30
Completion
2025-04-10

Countries

  • Kenya

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06165614 on ClinicalTrials.gov