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NCT06263582 · OUTCOME

To Determine the Maximum Concentration of Artesunate (AS)

Pharmacokinetics of Intravaginal, Self-administered Artesunate Vaginal Pessaries Among Women in Kenya · Source last updated 2025-08-19

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Day 5

What was measured

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.

Groups in this outcome

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. blood draws for pharmacokinetics of the study drug: 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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Artesunate Vaginal Inserts/ Pessaries12

Reported measurements

Source class 1
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Artesunate Vaginal Inserts/ Pessaries83.7442.73Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        42.73
        value
        83.74
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
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.
dispersion Type
Standard Deviation
groups
  1. description
    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. blood draws for pharmacokinetics of the study drug: 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.
    id
    OG000
    title
    Artesunate Vaginal Inserts/ Pessaries
param Type
MEAN
reporting Status
POSTED
time Frame
Day 5
title
To Determine the Maximum Concentration of Artesunate (AS)
type
SECONDARY
unit Of Measure
ng/mL

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice