A Phase 1 interventional study of Artesunate pessary and blood draws for pharmacokinetics of the study drug in Cervix Cancer, Cervix Intraepithelial Neoplasia Grade 3 and Cervix; Intraepithelial Neoplasia, Grade I, sponsored by UNC Lineberger Comprehensive Cancer Center. Completed at 1 site in Kenya. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-19.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Phase 1, Interventional, and Treatment
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.
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.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's enrollment of 12 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 414 studies on the registry; 96 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 25 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Artesunate vaginal inserts/pessaries are used as a treatment for cervical precancerous lesions.
Drug: Artesunate pessary · Diagnostic Test: blood draws for pharmacokinetics of the study drug
Subjects will use the study pessaries, placed in the vagina every day for 5 consecutive days.
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.
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.
Time frame: Day 5
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to day 10 days
Participants were recruited in one center in Kenya.
| Milestone | Artesunate Vaginal Inserts/ Pessaries |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
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.
| ng/mL-h | Artesunate Vaginal Inserts/ Pessaries |
|---|---|
| To Determine the Area Under the Plasma Concentration Versus Time Curve (AUC) of Dihydroartemisinin | 464.90 ± 228.70 |
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.
| ng/mL-h | Artesunate Vaginal Inserts/ Pessaries |
|---|---|
| To Determine the Area Under the Plasma Concentration Versus Time Curve (AUC) of Artesunate (AS) | 504.21 ± 281.11 |
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.
| ng/mL | Artesunate Vaginal Inserts/ Pessaries |
|---|---|
| To Determine the Maximum Concentration of Artesunate (AS) | 83.74 ± 42.73 |
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.
| ng/mL | Artesunate Vaginal Inserts/ Pessaries |
|---|---|
| To Determine the Maximum Concentration of Dihydroartemisinin (DHA) (Cmax) | 97.00 ± 53.12 |
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.
| hours | Artesunate Vaginal Inserts/ Pessaries |
|---|---|
| To Determine the Time to Maximum Concentration (Tmax) of Artesunate (AS) Following Five Consecutive Days | 4.17 ± 1.59 |
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.
| hours | Artesunate Vaginal Inserts/ Pessaries |
|---|---|
| To Determine the Time to Maximum Concentration (Tmax) of Dihydroartemisinin (DHA | 6.33 ± 1.67 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
| Participants | Artesunate Vaginal Inserts/ Pessaries |
|---|---|
| abdominal pain Grade 1 | 3 |
| vaginal discharge Grade 1 | 8 |
| Toothache- Grade 1 | 1 |
| vaginal fistula- Grade 2 | 1 |
| vaginal pruritis- Grade 1 | 1 |
Collected over Up to ten days after the study intervention (vaginal insertion of Artesunate pessaries).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Artesunate Vaginal Inserts/ Pessaries | 0/12 (0%) | 0/12 (0%) | 8/12 (66.7%) |
| Event | Artesunate Vaginal Inserts/ Pessaries |
|---|---|
| Vaginal dischargeReproductive system and breast disorders | 8/12 |
| Abdominal PainGastrointestinal disorders | 3/12 |
| ToothacheGastrointestinal disorders | 1/12 |
| Vaginal fistulaReproductive system and breast disorders | 1/12 |
| Pain in the extremityMusculoskeletal and connective tissue disorders | 1/12 |
| Vaginal pruritisReproductive system and breast disorders | 1/12 |
| Age, Continuous(years) | Artesunate Vaginal Inserts/ Pessaries |
|---|---|
| Mean | 23.3 ± 5.1 |
| Sex: Female, Male(Participants) | Artesunate Vaginal Inserts/ Pessaries |
|---|---|
| Female | 12 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Artesunate Vaginal Inserts/ Pessaries |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 12 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Artesunate Vaginal Inserts/ Pessaries |
|---|---|
| Kenya | 12 |
| Level of education(Participants) | Artesunate Vaginal Inserts/ Pessaries |
|---|---|
| College or higher | 2 |
| Completed Secondary | 10 |
| Occupation(Participants) | Artesunate Vaginal Inserts/ Pessaries |
|---|---|
| Salaried work | 1 |
| other | 1 |
| student | 10 |
| Marital Status(Participants) | Artesunate Vaginal Inserts/ Pessaries |
|---|---|
| Single/Never Married | 12 |
| Married | 0 |
| Electricity available(Participants) | Artesunate Vaginal Inserts/ Pessaries |
|---|---|
| yes | 11 |
| no | 1 |
3 further baseline measures are reported on the registry.
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