Artesunate Pessaries (Vaginal Inserts) for Cervical Precancer in Kenya

NCT ID: NCT06165614

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-04
• Study Completion Date: 2025-04-10

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.

Detailed Description

Despite being preventable, cancer of the cervix is a leading cause of cancer death in Kenya and other low- and middle-income countries (LMIC). Cervical cancer can be prevented if early changes in the cervix, called cervical precancer, are detected through screening, and adequately treated. Cervical precancer treatment includes a surgical procedure called Loop Electrosurgical Excision Procedure (LEEP), which removed the involved area of the cervix.

In countries like Kenya, this LEEP procedure is only available in referral hospitals which have trained consultants, and hence is difficult to access for most women who live in rural areas and away from tertiary facilities. Additionally, the LEEP procedure also increases the chance of a woman not being able to carry a pregnancy to full term, because the cervix is shorter after the procedure. For these reasons, alternative treatments, including self-administered treatments such as Artesunate are being investigated as alternative cervical precancer treatment that can be self-administered.

Conditions

Cervix Cancer; Cervix Neoplasm; Precancerous Conditions; Cervical Precancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Artesunate vaginal inserts/ pessaries

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

Group Type: EXPERIMENTAL

Artesunate pessary

Intervention Type: DRUG

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

Colposcopy

Intervention Type: PROCEDURE

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

Interventions

Artesunate pessary

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

Intervention Type: DRUG

Colposcopy

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Cervical lesions referred for excision with CIN2/3 diagnosis on biopsy

2. Weight ≥50 kg

3. Agreement to use contraception (barriers or hormonal) through week 24 of the study if of childbearing age.

4. Ability and willingness to provide informed consent.

Exclusion Criteria

1. Current pregnancy or breastfeeding status.

2. Current or past history of invasive cervical cancer.

3. History of total hysterectomy.

4. CD4 count less than 200 cells/mm3.

5. Presence of adenocarcinoma in situ on cervical biopsy

6. Currently receiving systemic chemotherapy or radiation therapy for another cancer

7. Current use of systemic immunosuppressants or steroids (>10 mg of prednisone or equivalent)

8. Have a medical comorbidity that in the opinion of the investigator would interfere with study participation.

9. Prior chemotherapy within 1 month prior to day 1 of study treatment

10. Male at birth

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chemtai Mungo, MD, MPH, FACOG

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Lumumba Sub-County Hospital

Kisumu, , Kenya

Countries

Kenya

Related Links

http://unclineberger.org/patientcare/clinical-trials/clinical-trials

University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Other Identifiers

LCCC2236

Identifier Type: -

Identifier Source: org_study_id