AzTrials
AzTrials

Cervix CancerPhase 1NCT06165614

Artesunate Pessaries (Vaginal Inserts) for Cervical Precancer in Kenya

A Phase 1 study testing Artesunate pessary and Colposcopy in people with Cervix Cancer and Cervix Neoplasm, run by UNC Lineberger Comprehensive Cancer Center at 1 site in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Artesunate pessary and Colposcopy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteKenya
Study dates
4 Mar 2024to 10 Apr 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Kenya1 site

  • Lumumba Sub-County Hospital

    Kisumu

Other trials in Kenya

About this study

Official title: Self-administered Artesunate Pessaries for Treatment of Cervical Precancer in Kenya

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.

Read the 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.

Being tested
Artesunate pessary, Colposcopy
Keywords
vaginal pessaries, artesunate
Medical subject headings
Uterine Cervical Neoplasms, Precancerous Conditions, Uterine Cervical Dysplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Artesunate pessaryDrug

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

  • ColposcopyProcedure or surgery

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

Study groups in NCT06165614
Study groupRoleWhat they receive
Artesunate vaginal inserts/ pessariesExperimentalArtesunate vaginal inserts/pessaries are used as a treatment for cervical precancerous lesions.
Receives: Drug: Artesunate pessary; Procedure: Colposcopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (4)

  1. Adherence

    Adherence will be evaluated based on participant self-report, returned packaging for used pessaries, and inspection of vaginal applicators under ultraviolet light for evidence of intravaginal insertion. A participant will be considered adherent if both methods support use of 80% (16 of 20) of the pessaries.

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

  2. Change in lesion

    Change in lesion size will be assessed by comparing colposcopic images of cervical lesions at baseline compared to the time of excision or week 24, whichever comes earlier, noting changes in the number and size of lesions and cervical quadrants involved. Blinded before and after treatment images will be evaluated by two gynecologists not involved in the study for evidence of a reduction in lesion size (Yes/No). A third gynecologist will be used as a tiebreaker if the two do not agree. The difference in proportions with the reduction in lesion size between the HIV-positive and HIV-negative groups will be reported.

    Measured: From the first day of the study treatment to week 24

  3. Histologic regression

    Histologic regression will be evaluated by comparing the initial diagnostic biopsy at study entry with the exit biopsy or excisional specimen final diagnosis. Participants who have complete regression at follow-up will have a confirmatory biopsy at the lesion site which will be used for final diagnosis. Regression will be defined as CIN1 or less in the resection or biopsy specimen. All specimens will be reviewed by a pathologist in-country and slides scanned for review by a 2nd pathologist at UNC. A 3rd pathologist will be utilized for consensus if the first two pathologists disagree. The difference in proportions with the histologic regression between the HIV-positive and HIV-negative groups will be reported.

    Measured: From the first day of the study treatment to week 24

  4. Acceptability

    Acceptability will be assessed using a questionnaire with study participants using Artesunate. Responses to questions will be graded on a Likert scale. The Likert scale has questions from 1 to 6. Higher scores represent better QOL.

    Measured: At week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2023
  2. Study start4 Mar 2024
  3. Primary completion30 Jan 2025
  4. Study completion10 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06165614
Sponsor's protocol ID
LCCC2236
Status last verified
Aug 2025
First submitted
21 Nov 2023
Last updated
19 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This can be requested and provided under reasonable request.

Publications

  • Sadana A, Guliam A, Opiyo EA, Adundo F, Sorgi K, Agha E, Mungo C. "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 Jun 29;18:573262. doi: 10.2147/IJWH.S573262. eCollection 2026.

    PubMed 42403515

  • 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.

    PubMed 41415498

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Artesunate pessary and Colposcopy in people with Cervix Cancer and Cervix Neoplasm, run by UNC Lineberger Comprehensive Cancer Center at 1 site in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the type, frequency, severity and duration of adverse events (time frame: From the first day of the study treatment to week 14 ( 8 weeks after artesunate use)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06165614, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in