NCT06263582 · REGISTRY CONDITION SEARCH

Pharmacokinetics of Intravaginal, Self-administered Artesunate Vaginal Pessaries Among Women in Kenya

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1
Status at capture: COMPLETED
Registry last update: 2025-08-19

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

To Determine the Area Under the Plasma Concentration Versus Time Curve (AUC) of Dihydroartemisinin

→

outcome · POSTED

To Determine the Area Under the Plasma Concentration Versus Time Curve (AUC) of Artesunate (AS)

→

outcome · POSTED

To Determine the Maximum Concentration of Artesunate (AS)

→

outcome · POSTED

To Determine the Maximum Concentration of Dihydroartemisinin (DHA) (Cmax)

→

outcome · POSTED

To Determine the Time to Maximum Concentration (Tmax) of Artesunate (AS) Following Five Consecutive Days

→

outcome · POSTED

To Determine the Time to Maximum Concentration (Tmax) of Dihydroartemisinin (DHA

→

outcome · POSTED

To Determine the Half-life (t1/2) of Artesunate (AS)

→

outcome · POSTED

To Determine the Half-life (t1/2) of Dihydroartemisinin (DHA)

→

outcome · POSTED

To Determine the Apparent Clearance (CL/F) of Artesunate (AS)

→

outcome · POSTED

To Determine the Apparent Clearance (CL/F) of Dihydroartemisinin (DHA)

→

outcome · POSTED

To Determine the Volume of Distribution (V/F) of Artesunate (AS)

→

outcome · POSTED

To Determine the Volume of Distribution (V/F) of Dihydroartemisinin (DHA)

→

outcome · POSTED

Type, Frequency, Severity, and Duration of Adverse Events

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: Inclusion Criteria 1. Age 18 years or older 2. Negative pregnancy test at screening 3. Willingness to use contraception (hormonal or barrier) during the 5-day study dosing phase if of childbearing age (less than 50 years of age) 4. Ability and willingness to provide informed consent. Exclusion Criteria 1. Current pregnancy or breastfeeding status 2. History of total hysterectomy 3. Known allergy to Artesunate. 4. Have a medical comorbidity that in the opinion of the investigator would interfere with study participation. 5. Currently receiving artemisinin-based agents for malaria treatment or completed artemisinin-based treatment within the previous 3 days.
gender Based: true
gender Description: Women are eligible
healthy Volunteers: true
maximum Age: 65 Years
minimum Age: 18 Years
sex: FEMALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Artesunate vaginal inserts/pessaries are used as a treatment for cervical precancerous lesions.
intervention Names
Drug: Artesunate pessary
Diagnostic Test: blood draws for pharmacokinetics of the study drug
label
Artesunate vaginal inserts/ pessaries
type
EXPERIMENTAL

interventions

arm Group Labels
Artesunate vaginal inserts/ pessaries
description
Subjects will use the study pessaries, placed in the vagina every day for 5 consecutive days.
name
Artesunate pessary
type
DRUG
arm Group Labels
Artesunate vaginal inserts/ pessaries
description
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.
name
blood draws for pharmacokinetics of the study drug
type
DIAGNOSTIC_TEST

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 12
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
To Determine the Area Under the Plasma Concentration Versus Time Curve (AUC) of Dihydroartemisinin
time Frame
Day 5

secondary Outcomes

description
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.
measure
To Determine the Area Under the Plasma Concentration Versus Time Curve (AUC) of Artesunate (AS)
time Frame
Day 5
description
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.
measure
To Determine the Maximum Concentration of Artesunate (AS)
time Frame
Day 5
description
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.
measure
To Determine the Maximum Concentration of Dihydroartemisinin (DHA) (Cmax)
time Frame
Day 5
description
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.
measure
To Determine the Time to Maximum Concentration (Tmax) of Artesunate (AS) Following Five Consecutive Days
time Frame
Day 5
description
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.
measure
To Determine the Time to Maximum Concentration (Tmax) of Dihydroartemisinin (DHA
time Frame
Day 5
description
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.
measure
To Determine the Half-life (t1/2) of Artesunate (AS)
time Frame
Day 5
description
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.
measure
To Determine the Half-life (t1/2) of Dihydroartemisinin (DHA)
time Frame
Day 5
description
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.
measure
To Determine the Apparent Clearance (CL/F) of Artesunate (AS)
time Frame
Day 5
description
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.
measure
To Determine the Apparent Clearance (CL/F) of Dihydroartemisinin (DHA)
time Frame
Day 5
description
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.
measure
To Determine the Volume of Distribution (V/F) of Artesunate (AS)
time Frame
Day 5
description
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.
measure
To Determine the Volume of Distribution (V/F) of Dihydroartemisinin (DHA)
time Frame
Day 5
description
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.
measure
Type, Frequency, Severity, and Duration of Adverse Events
time Frame
Up to day 10 days

Full study description

brief 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.
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.

Source references