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NCT01370551 · OUTCOME

Calculation of Pharmacokinetic Parameters Estriol: Tmax

Clinical Study of Vaginal Lactobacilli and Estriol (Gynoflor®) for Atrophic Vaginitis in Breast Cancer Patients · Source last updated 2024-10-15

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
Days 0 and 28

What was measured

Tmax is the peak time at which the Cmax (maximum concentration) was measured

Groups in this outcome

Gynoflor

Gynoflor: Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; Once daily for 28 days then 3 times per week for 8 weeks;

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

Analysis denominator · Participants

GroupSource count
Gynoflor16

Reported measurements

Tmax (Day 0)
Values in hours · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Gynoflor2.50.5Not reportedNot reportedNot reported
Tmax (Day 28)
Values in hours · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Gynoflor7.21.5Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.5
        value
        2.5
    title
    Tmax (Day 0)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.5
        value
        7.2
    title
    Tmax (Day 28)
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    units
    Participants
description
Tmax is the peak time at which the Cmax (maximum concentration) was measured
dispersion Type
Standard Deviation
groups
  1. description
    Gynoflor: Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; Once daily for 28 days then 3 times per week for 8 weeks;
    id
    OG000
    title
    Gynoflor
param Type
MEAN
reporting Status
POSTED
time Frame
Days 0 and 28
title
Calculation of Pharmacokinetic Parameters Estriol: Tmax
type
PRIMARY
unit Of Measure
hours

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

Preserved source evidence · Not medical advice