Cervix CancerPhase 1NCT06263582
Pharmacokinetics of Intravaginal, Self-administered Artesunate Vaginal Pessaries Among Women in Kenya
A Phase 1 study testing Artesunate pessary and blood draws for pharmacokinetics of the study drug in people with Cervix Cancer and Cervix Intraepithelial Neoplasia Grade 3, run by UNC Lineberger Comprehensive Cancer Center at 1 site in Kenya.
Trial summary
This study investigates the pharmacokinetics of Artesunate (AS) and dihydroartemisinin (DHA), the active metabolite of Artesunate, following intravaginal use at the dosing and frequency being studied for cervical precancer treatment. A secondary objective is to investigate safety among study participants. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervix Cancer, Cervix Intraepithelial Neoplasia Grade 3, Cervix; Intraepithelial Neoplasia, Grade I
- What is being tested?
- Artesunate pessary and blood draws for pharmacokinetics of the study drug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteKenya
- Study dates
- 29 May 2024to 14 Aug 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Negative pregnancy test at screening
- Willingness to use contraception (hormonal or barrier) during the 5-day study dosing phase if of childbearing age (less than 50 years of age)
- Ability and willingness to provide informed consent.
Who cannot join
- Current pregnancy or breastfeeding status
- History of total hysterectomy
- Known allergy to Artesunate.
- Have a medical comorbidity that in the opinion of the investigator would interfere with study participation.
- Currently receiving artemisinin-based agents for malaria treatment or completed artemisinin-based treatment within the previous 3 days.
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates the pharmacokinetics of Artesunate (AS) and dihydroartemisinin (DHA), the active metabolite of Artesunate, following intravaginal use at the dosing and frequency being studied for cervical precancer treatment. A secondary objective is to investigate safety among study participants.
Read the detailed description
Due to lack of access to primary and secondary prevention, women living in low-and middle-income countries bear a disproportionate burden of cervical cancer, accounting for 90% of new cases and 85% of deaths globally. Cervical cancer can be prevented through vaccination against Human papillomavirus (HPV), whose infection is required to develop cervical cancer. Among unvaccinated women, screening for HPV or cervical precancer allows identification of precancerous lesions - primarily cervical intraepithelial neoplasia grade 2 or 3 (CIN2/3), that can be treated and cured, to prevent progression to cancer. Most CIN2/3 lesions that are left untreated will progress to invasive cervical cancer. Current treatments for CIN2/3 in both high- and low-resource countries (LMICs) require trained health care providers, who are often out of reach for many women, particularly in rural areas in LMICs. Lack of access to precancer treatment following screening in LMICs in part accounts for the high burden of incident cervical cancer. Preclinical data have demonstrated pro-apoptotic effects of Artesunate (AS), a commonly available drug with an excellent safety profile in oral, rectal and intravenous routes primarily used to treat malaria in LMICs. This led to a recent Phase I study in the United States that demonstrated that self-administered vaginal artesunate inserts (pessaries) are safe, well-tolerated, and demonstrate efficacy for treatment of CIN2/3. Based on the mechanism of action, the clinical safety profile, and widespread availability as a generic drug on the World Health Organization (WHO) List of Essential Medications, vaginal artesunate inserts (pessaries), if backed by data from randomized trials, may offer patient-controlled and access cervical precancer treatment method for women in LMICs who face the greatest burden of cervical cancer and have difficulty accessing skilled providers for precancer treatment. However, given that artesunate is a well-known drug used in malaria treatment, it is critical to ensure that vaginal application of the drug will not promote resistance for use in malaria treatment.
- Conditions
- Cervix Cancer, Cervix Intraepithelial Neoplasia Grade 3, Cervix; Intraepithelial Neoplasia, Grade I, Cervix; Intraepithelial Neoplasia, Grade II
- Being tested
- Artesunate pessary, blood draws for pharmacokinetics of the study drug
- Keywords
- Artesunate, dihydroartemisinin, pharmacokinetics
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia, Carcinoma in Situ, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artesunate pessaryDrug
Subjects will use the study pessaries, placed in the vagina every day for 5 consecutive days.
blood draws for pharmacokinetics of the study drugDiagnostic test
On day 5, all participants will have their blood draws before they use the pessary, and at 15 min, 30 mins, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours after inserting the pessary. Blood samples will be tested for the pharmacokinetics of the study drug.
| Study group | Role | What they receive |
|---|---|---|
| Artesunate vaginal inserts/ pessaries | Experimental | Artesunate vaginal inserts/pessaries are used as a treatment for cervical precancerous lesions. Receives: Drug: Artesunate pessary; Diagnostic Test: blood draws for pharmacokinetics of the study drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Determine the Area Under the Plasma Concentration Versus Time Curve (AUC) of Dihydroartemisinin
To determine the area under the plasma concentration versus time curve (AUC) of dihydroartemisinin (DHA) following five consecutive days of self-administration of 200mg Artesunate vaginal inserts (pessaries). Mean DHA AUC will be submitted.
Measured: Day 5
Secondary outcomes (12)
To Determine the Area Under the Plasma Concentration Versus Time Curve (AUC) of Artesunate (AS)
To determine the area under the plasma concentration versus time curve (AUC) of Artesunate (AS) following five consecutive days of self-administration of 200mg Artesunate vaginal inserts (pessaries). Mean artesunate AUC will be submitted.
Measured: Day 5
To Determine the Maximum Concentration of Artesunate (AS)
To determine the maximum concentration of Artesunate (AS) (Cmax) following five consecutive days of self-administration of 200mg Artesunate vaginal inserts (pessaries) among healthy women.
Mean artesunate Cmax (ng/ml) value will be submitted.
Measured: Day 5
To Determine the Maximum Concentration of Dihydroartemisinin (DHA) (Cmax)
To determine the maximum concentration of dihydroartemisinin (DHA) (Cmax) following five consecutive days of self-administration of 200mg Artesunate vaginal inserts (pessaries) among healthy women.
Mean DHA Cmax (ng/ml) value will be submitted.
Measured: Day 5
To Determine the Time to Maximum Concentration (Tmax) of Artesunate (AS) Following Five Consecutive Days
To determine the time to maximum concentration (Tmax) of Artesunate (AS) following five consecutive days of self-administration of 200mg Artesunate vaginal inserts (pessaries) among healthy women.
Mean DHA Tmax (hours) value will be submitted.
Measured: Day 5
To Determine the Time to Maximum Concentration (Tmax) of Dihydroartemisinin (DHA
To determine the time to maximum concentration (Tmax) of dihydroartemisinin (DHA) following five consecutive days of self-administration of 200mg Artesunate vaginal inserts (pessaries) among healthy women.
Mean (Tmax) will be submitted.
Measured: Day 5
To Determine the Half-life (t1/2) of Artesunate (AS)
To determine the half-life (t1/2) of Artesunate (AS) following five consecutive days of self-administration of 200mg Artesunate vaginal inserts (pessaries) among healthy women. Mean Artesunate half-life (t1/2) (mins) will be submitted.
Measured: Day 5
To Determine the Half-life (t1/2) of Dihydroartemisinin (DHA)
To determine the half-life (t1/2) of dihydroartemisinin (DHA) following five consecutive days of self-administration of 200mg Artesunate vaginal inserts (pessaries) among healthy women.
Mean DHA half-life (mins) will be submitted.
Measured: Day 5
To Determine the Apparent Clearance (CL/F) of Artesunate (AS)
To determine the apparent clearance (CL/F) of Artesunate (AS) following five consecutive days of self-administration of 200mg Artesunate vaginal inserts (pessaries) among healthy women.
Mean Artesunate clearance (L/Kg/hr) will be submitted.
Measured: Day 5
To Determine the Apparent Clearance (CL/F) of Dihydroartemisinin (DHA)
To determine the apparent clearance (CL/F) of dihydroartemisinin (DHA) following five consecutive days of self-administration of 200mg Artesunate vaginal inserts (pessaries) among healthy women.
Mean DHA clearance (L/Kg/hr) will be submitted.
Measured: Day 5
To Determine the Volume of Distribution (V/F) of Artesunate (AS)
To determine the volume of distribution (V/F) of Artesunate (AS) following five consecutive days of self-administration of 200mg Artesunate vaginal inserts (pessaries) among healthy women.
Mean Artesunate volume of distribution (L/Kg) will be submitted.
Measured: Day 5
To Determine the Volume of Distribution (V/F) of Dihydroartemisinin (DHA)
To determine the volume of distribution (V/F) of dihydroartemisinin (DHA) following five consecutive days of self-administration of 200mg Artesunate vaginal inserts (pessaries) among healthy women.
Mean dihydroartemisinin (DHA) of distribution (V/F) will be submitted.
Measured: Day 5
Type, Frequency, Severity, and Duration of Adverse Events
To investigate the safety of a 5-day course of self-administered intravaginal artesunate vaginal inserts (pessary) in women. Type, frequency, severity, and duration of reported and observed adverse events (AEs) using the U.S National Cancer Institute Common Terminology Criteria for Adverse Events, v5.0 (CTCAE 5.0) and the Division of AIDS Female Genital Adverse Events Grading Table will be submitted.
Measured: Up to day 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start29 May 2024
- Primary completion14 Aug 2024
- Study completion14 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervix CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Chemtai Mungo, MD, MPH, FACOG, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263582
- Sponsor's protocol ID
- IGHID12333
- Other IDs
- K12HD103085
- Status last verified
- Jul 2025
- First submitted
- 8 Feb 2024
- Last updated
- 19 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Intravaginal, Self-administered Artesunate Vaginal Pessaries Among Women in Kenya
- ClinicalTrials.gov ID
- NCT06263582
- Acronym / sponsor ID
- IGHID12333
- Conditions
- Cervix Cancer, Cervix Intraepithelial Neoplasia Grade 3, Cervix; Intraepithelial Neoplasia, Grade I, Cervix; Intraepithelial Neoplasia, Grade II
- Keywords
- Artesunate, dihydroartemisinin, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 29 May 2024 (actual)
- Primary completion
- 14 Aug 2024 (actual)
- Study completion
- 14 Aug 2024 (actual)
- First posted
- 16 Feb 2024 (actual)
- Results
- Posted 19 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the pharmacokinetics of Artesunate (AS) and dihydroartemisinin (DHA), the active metabolite of Artesunate, following intravaginal use at the dosing and frequency being studied for cervical precancer treatment. A secondary objective is to investigate safety among study participants.
Detailed description
Due to lack of access to primary and secondary prevention, women living in low-and middle-income countries bear a disproportionate burden of cervical cancer, accounting for 90% of new cases and 85% of deaths globally. Cervical cancer can be prevented through vaccination against Human papillomavirus (HPV), whose infection is required to develop cervical cancer. Among unvaccinated women, screening for HPV or cervical precancer allows identification of precancerous lesions - primarily cervical intraepithelial neoplasia grade 2 or 3 (CIN2/3), that can be treated and cured, to prevent progression to cancer. Most CIN2/3 lesions that are left untreated will progress to invasive cervical cancer. Current treatments for CIN2/3 in both high- and low-resource countries (LMICs) require trained health care providers, who are often out of reach for many women, particularly in rural areas in LMICs. Lack of access to precancer treatment following screening in LMICs in part accounts for the high burden of incident cervical cancer. Preclinical data have demonstrated pro-apoptotic effects of Artesunate (AS), a commonly available drug with an excellent safety profile in oral, rectal and intravenous routes primarily used to treat malaria in LMICs. This led to a recent Phase I study in the United States that demonstrated that self-administered vaginal artesunate inserts (pessaries) are safe, well-tolerated, and demonstrate efficacy for treatment of CIN2/3. Based on the mechanism of action, the clinical safety profile, and widespread availability as a generic drug on the World Health Organization (WHO) List of Essential Medications, vaginal artesunate inserts (pessaries), if backed by data from randomized trials, may offer patient-controlled and access cervical precancer treatment method for women in LMICs who face the greatest burden of cervical cancer and have difficulty accessing skilled providers for precancer treatment. However, given that artesunate is a well-known drug used in malaria treatment, it is critical to ensure that vaginal application of the drug will not promote resistance for use in malaria treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Artesunate vaginal inserts/ pessaries | Experimental | Drug: Artesunate pessary, Diagnostic Test: blood draws for pharmacokinetics of the study drugArtesunate vaginal inserts/pessaries are used as a treatment for cervical precancerous lesions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Negative pregnancy test at screening
- Willingness to use contraception (hormonal or barrier) during the 5-day study dosing phase if of childbearing age (less than 50 years of age)
- Ability and willingness to provide informed consent.
Key exclusion criteria (5 listed)
- Current pregnancy or breastfeeding status
- History of total hysterectomy
- Known allergy to Artesunate.
- Have a medical comorbidity that in the opinion of the investigator would interfere with study participation.
- Currently receiving artemisinin-based agents for malaria treatment or completed artemisinin-based treatment within the previous 3 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artesunate pessarySubjects will use the study pessaries, placed in the vagina every day for 5 consecutive days. | Drug | Artesunate vaginal inserts/ pessaries |
| blood draws for pharmacokinetics of the study drugOn day 5, all participants will have their blood draws before they use the pessary, and at 15 min, 30 mins, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours after inserting the pessary. Blood samples will be tested for the pharmacokinetics of the study drug. | Diagnostic test | Artesunate vaginal inserts/ pessaries |
Primary outcome
To Determine the Area Under the Plasma Concentration Versus Time Curve (AUC) of Dihydroartemisinin
Time frame: Day 5
To determine the area under the plasma concentration versus time curve (AUC) of dihydroartemisinin (DHA) following five consecutive days of self-administration of 200mg Artesunate vaginal inserts (pessaries). Mean DHA AUC will be submitted.
12 secondary outcomes
To Determine the Area Under the Plasma Concentration Versus Time Curve (AUC) of Artesunate (AS)
Time frame: Day 5
To Determine the Maximum Concentration of Artesunate (AS)
Time frame: Day 5
To Determine the Maximum Concentration of Dihydroartemisinin (DHA) (Cmax)
Time frame: Day 5
To Determine the Time to Maximum Concentration (Tmax) of Artesunate (AS) Following Five Consecutive Days
Time frame: Day 5
To Determine the Time to Maximum Concentration (Tmax) of Dihydroartemisinin (DHA
Time frame: Day 5
To Determine the Half-life (t1/2) of Artesunate (AS)
Time frame: Day 5
To Determine the Half-life (t1/2) of Dihydroartemisinin (DHA)
Time frame: Day 5
To Determine the Apparent Clearance (CL/F) of Artesunate (AS)
Time frame: Day 5
To Determine the Apparent Clearance (CL/F) of Dihydroartemisinin (DHA)
Time frame: Day 5
To Determine the Volume of Distribution (V/F) of Artesunate (AS)
Time frame: Day 5
To Determine the Volume of Distribution (V/F) of Dihydroartemisinin (DHA)
Time frame: Day 5
Type, Frequency, Severity, and Duration of Adverse Events
Time frame: Up to day 10 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chemtai Mungo, MD, MPH, FACOG principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Artesunate pessary and blood draws for pharmacokinetics of the study drug in people with Cervix Cancer and Cervix Intraepithelial Neoplasia Grade 3, 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 5 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?
Yes. Results are posted in the registry (first posted 19 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Determine the Area Under the Plasma Concentration Versus Time Curve (AUC) of Dihydroartemisinin (time frame: Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.