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NCT06263582 · OUTCOME

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

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
hours
Interval / dispersion
Standard Deviation
Time frame
Day 5

What was measured

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.

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.

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 hours · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Artesunate Vaginal Inserts/ Pessaries4.171.59Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.59
        value
        4.17
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
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.
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.
    id
    OG000
    title
    Artesunate Vaginal Inserts/ Pessaries
param Type
MEAN
reporting Status
POSTED
time Frame
Day 5
title
To Determine the Time to Maximum Concentration (Tmax) of Artesunate (AS) Following Five Consecutive Days
type
SECONDARY
unit Of Measure
hours

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

Preserved source evidence · Not medical advice