Trial Outcomes & Findings for Pharmacokinetics of Intravaginal, Self-administered Artesunate Vaginal Pessaries Among Women in Kenya (NCT NCT06263582)
NCT ID: NCT06263582
Last Updated: 2025-08-19
Results Overview
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.
COMPLETED
PHASE1
12 participants
Day 5
2025-08-19
Participant Flow
Participants were recruited in one center in Kenya.
Twelve participants consented and found eligible.
Participant milestones
| Measure |
Artesunate Vaginal Inserts/ Pessaries
Artesunate vaginal inserts/pessaries are used as a treatment for cervical precancerous lesions.
Artesunate pessary: Subjects will use the study pessaries, placed in the vagina every day for 5 consecutive days.
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|---|---|
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Overall Study
STARTED
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12
|
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Overall Study
COMPLETED
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12
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics of Intravaginal, Self-administered Artesunate Vaginal Pessaries Among Women in Kenya
Baseline characteristics by cohort
| Measure |
Artesunate Vaginal Inserts/ Pessaries
n=12 Participants
Artesunate vaginal inserts/pessaries are used as a treatment for cervical precancerous lesions.
Artesunate pessary: Subjects will use the study pessaries, placed in the vagina every day for 5 consecutive days.
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|---|---|
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Age, Continuous
|
23.3 years
STANDARD_DEVIATION 5.1 • n=99 Participants
|
|
Sex: Female, Male
Female
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12 Participants
n=99 Participants
|
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Sex: Female, Male
Male
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
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12 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
Kenya
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12 participants
n=99 Participants
|
|
Level of education
College or higher
|
2 Participants
n=99 Participants
|
|
Level of education
Completed Secondary
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10 Participants
n=99 Participants
|
|
Occupation
Salaried work
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1 Participants
n=99 Participants
|
|
Occupation
other
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1 Participants
n=99 Participants
|
|
Occupation
student
|
10 Participants
n=99 Participants
|
|
Marital Status
Single/Never Married
|
12 Participants
n=99 Participants
|
|
Marital Status
Married
|
0 Participants
n=99 Participants
|
|
Electricity available
yes
|
11 Participants
n=99 Participants
|
|
Electricity available
no
|
1 Participants
n=99 Participants
|
|
Tap water available
yes
|
10 Participants
n=99 Participants
|
|
Tap water available
No
|
2 Participants
n=99 Participants
|
|
Current or prior tobacco use
yes
|
2 Participants
n=99 Participants
|
|
Current or prior tobacco use
No
|
10 Participants
n=99 Participants
|
|
Current or prior alcohol use
Yes
|
9 Participants
n=99 Participants
|
|
Current or prior alcohol use
No
|
3 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 5To 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.
Outcome measures
| Measure |
Artesunate Vaginal Inserts/ Pessaries
n=12 Participants
Artesunate vaginal inserts/pessaries are used as a treatment for cervical precancerous lesions.
Artesunate pessary: Subjects will use the study pessaries, placed in the vagina every day for 5 consecutive days.
|
|---|---|
|
To Determine the Area Under the Plasma Concentration Versus Time Curve (AUC) of Dihydroartemisinin
|
464.90 ng/mL-h
Standard Deviation 228.70
|
SECONDARY outcome
Timeframe: Day 5To 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.
Outcome measures
| Measure |
Artesunate Vaginal Inserts/ Pessaries
n=12 Participants
Artesunate vaginal inserts/pessaries are used as a treatment for cervical precancerous lesions.
Artesunate pessary: Subjects will use the study pessaries, placed in the vagina every day for 5 consecutive days.
|
|---|---|
|
To Determine the Area Under the Plasma Concentration Versus Time Curve (AUC) of Artesunate (AS)
|
504.21 ng/mL-h
Standard Deviation 281.11
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SECONDARY outcome
Timeframe: Day 5To 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.
Outcome measures
| Measure |
Artesunate Vaginal Inserts/ Pessaries
n=12 Participants
Artesunate vaginal inserts/pessaries are used as a treatment for cervical precancerous lesions.
Artesunate pessary: Subjects will use the study pessaries, placed in the vagina every day for 5 consecutive days.
|
|---|---|
|
To Determine the Maximum Concentration of Artesunate (AS)
|
83.74 ng/mL
Standard Deviation 42.73
|
SECONDARY outcome
Timeframe: Day 5To 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.
Outcome measures
| Measure |
Artesunate Vaginal Inserts/ Pessaries
n=12 Participants
Artesunate vaginal inserts/pessaries are used as a treatment for cervical precancerous lesions.
Artesunate pessary: Subjects will use the study pessaries, placed in the vagina every day for 5 consecutive days.
|
|---|---|
|
To Determine the Maximum Concentration of Dihydroartemisinin (DHA) (Cmax)
|
97.00 ng/mL
Standard Deviation 53.12
|
SECONDARY outcome
Timeframe: Day 5To 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.
Outcome measures
| Measure |
Artesunate Vaginal Inserts/ Pessaries
n=12 Participants
Artesunate vaginal inserts/pessaries are used as a treatment for cervical precancerous lesions.
Artesunate pessary: Subjects will use the study pessaries, placed in the vagina every day for 5 consecutive days.
|
|---|---|
|
To Determine the Time to Maximum Concentration (Tmax) of Artesunate (AS) Following Five Consecutive Days
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4.17 hours
Standard Deviation 1.59
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SECONDARY outcome
Timeframe: Day 5To 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.
Outcome measures
| Measure |
Artesunate Vaginal Inserts/ Pessaries
n=12 Participants
Artesunate vaginal inserts/pessaries are used as a treatment for cervical precancerous lesions.
Artesunate pessary: Subjects will use the study pessaries, placed in the vagina every day for 5 consecutive days.
|
|---|---|
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To Determine the Time to Maximum Concentration (Tmax) of Dihydroartemisinin (DHA
|
6.33 hours
Standard Deviation 1.67
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SECONDARY outcome
Timeframe: Day 5Population: The plasma half-life of Artesunate could not be estimated because the concentration versus time profiles did not reach an elimination phase (i.e., the concentration versus time profile did not decrease) from 0 to 8h post administration of intravaginal artesunate.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 5Population: The plasma half-life of dihydroartemisinin (DHA) could not be estimated because the concentration versus time profiles did not reach an elimination phase (i.e., the concentration versus time profile did not decrease) from 0 to 8h post administration.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 5Population: The plasma apparent clearance (CL/F) of Artesunate could not be estimated because the concentration versus time profiles of both forms did not reach an elimination phase (i.e., the concentration versus time profile did not decrease) from 0 to 8h post administration of intravaginal artesunate.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 5Population: The plasma apparent clearance (CL/F) of dihydroartemisinin (DHA) could not be estimated because the concentration versus time profiles of both forms did not reach an elimination phase (i.e., the concentration versus time profile did not decrease) from 0 to 8h post administration.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 5Population: The plasma volume of distribution (V/F) of Artesunate (AS) could not be estimated because the concentration versus time profiles of both forms did not reach an elimination phase (i.e., the concentration versus time profile did not decrease) from 0 to 8h post administration of intravaginal artesunate.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 5Population: The plasma volume of distribution (V/F) of dihydroartemisinin (DHA) could not be estimated because the concentration versus time profiles of both forms did not reach an elimination phase (i.e., the concentration versus time profile did not decrease) from 0 to 8h post administration.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to day 10 daysTo 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.
Outcome measures
| Measure |
Artesunate Vaginal Inserts/ Pessaries
n=12 Participants
Artesunate vaginal inserts/pessaries are used as a treatment for cervical precancerous lesions.
Artesunate pessary: Subjects will use the study pessaries, placed in the vagina every day for 5 consecutive days.
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|---|---|
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Type, Frequency, Severity, and Duration of Adverse Events
abdominal pain Grade 1
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3 Participants
|
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Type, Frequency, Severity, and Duration of Adverse Events
vaginal discharge Grade 1
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8 Participants
|
|
Type, Frequency, Severity, and Duration of Adverse Events
Toothache- Grade 1
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1 Participants
|
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Type, Frequency, Severity, and Duration of Adverse Events
vaginal fistula- Grade 2
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1 Participants
|
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Type, Frequency, Severity, and Duration of Adverse Events
vaginal pruritis- Grade 1
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1 Participants
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Adverse Events
Artesunate Vaginal Inserts/ Pessaries
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Artesunate Vaginal Inserts/ Pessaries
n=12 participants at risk
Artesunate vaginal inserts/pessaries are used as a treatment for cervical precancerous lesions.
Artesunate pessary: Subjects will use the study pessaries, placed in the vagina every day for 5 consecutive days.
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|---|---|
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Gastrointestinal disorders
Abdominal Pain
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25.0%
3/12 • Up to ten days after the study intervention (vaginal insertion of Artesunate pessaries).
AEs were collected according to National Cancer Institute Common Terminology Criteria for Adverse Events, v5.0 (CTCAE 5.0)
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Reproductive system and breast disorders
Vaginal discharge
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66.7%
8/12 • Up to ten days after the study intervention (vaginal insertion of Artesunate pessaries).
AEs were collected according to National Cancer Institute Common Terminology Criteria for Adverse Events, v5.0 (CTCAE 5.0)
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Gastrointestinal disorders
Toothache
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8.3%
1/12 • Up to ten days after the study intervention (vaginal insertion of Artesunate pessaries).
AEs were collected according to National Cancer Institute Common Terminology Criteria for Adverse Events, v5.0 (CTCAE 5.0)
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Reproductive system and breast disorders
Vaginal fistula
|
8.3%
1/12 • Up to ten days after the study intervention (vaginal insertion of Artesunate pessaries).
AEs were collected according to National Cancer Institute Common Terminology Criteria for Adverse Events, v5.0 (CTCAE 5.0)
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Musculoskeletal and connective tissue disorders
Pain in the extremity
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8.3%
1/12 • Up to ten days after the study intervention (vaginal insertion of Artesunate pessaries).
AEs were collected according to National Cancer Institute Common Terminology Criteria for Adverse Events, v5.0 (CTCAE 5.0)
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Reproductive system and breast disorders
Vaginal pruritis
|
8.3%
1/12 • Up to ten days after the study intervention (vaginal insertion of Artesunate pessaries).
AEs were collected according to National Cancer Institute Common Terminology Criteria for Adverse Events, v5.0 (CTCAE 5.0)
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place