Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02413008 · OUTCOME

Changes in Vaginal Maturation Value

A Clinical Trial to Assess the Safety of 0.005 % Estriol Vaginal Gel in Hormone Receptor-Positive Postmenopausal Women With Early Stage Breast Cancer in Treatment With Aromatase Inhibitor in the Adjuvant Setting · Source last updated 2019-08-05

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

Measure
MEDIAN
Unit
% of cells
Interval / dispersion
Inter-Quartile Range
Time frame
week 3 and week 12 vs baseline

What was measured

Vaginal cytology sample to evaluate the vaginal Maturation Value. For the cytologic evaluation, the number of parabasal, intermediate and superficial cells will be calculated in duplicate on 100 consecutive cells of vaginal cytology. The average of the two percentages obtained for each cell type will be calculated, which will serve to determine the maturation value (MV) based on the following formula: 0.2 x (% parabasal) + 0.6 x (% intermediate) + 1.0 x (% superficial).

Analysis population: postmenopausal women

Groups in this outcome

0.005% Estriol Vaginal Gel

Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration

Placebo Vaginal Gel

Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration Placebo

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

Analysis denominator · Participants

GroupSource count
0.005% Estriol Vaginal Gel50
Placebo Vaginal Gel11

Reported measurements

Change between baseline and week 3
Values in % of cells · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
0.005% Estriol Vaginal Gel-62.0Not reported-70.04-37.8Not reported
Placebo Vaginal Gel-0.6Not reported-11.62.0Not reported
Change between baseline and week 12
Values in % of cells · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
0.005% Estriol Vaginal Gel-37.2Not reported-55.0-5.4Not reported
Placebo Vaginal Gel-1.0Not reported-36.41.4Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Description
    Change in maturation value from baseline to week 3
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    <0.0001
    statistical Method
    Wilcoxon (Mann-Whitney)
  2. group Description
    Change in maturation value from baseline to week 12
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.006
    statistical Method
    Wilcoxon (Mann-Whitney)
Complete source fields
analyses
  1. group Description
    Change in maturation value from baseline to week 3
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    <0.0001
    statistical Method
    Wilcoxon (Mann-Whitney)
  2. group Description
    Change in maturation value from baseline to week 12
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.006
    statistical Method
    Wilcoxon (Mann-Whitney)
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -70.04
        upper Limit
        -37.8
        value
        -62.0
      2. group Id
        OG001
        lower Limit
        -11.6
        upper Limit
        2.0
        value
        -0.6
    title
    Change between baseline and week 3
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -55.0
        upper Limit
        -5.4
        value
        -37.2
      2. group Id
        OG001
        lower Limit
        -36.4
        upper Limit
        1.4
        value
        -1.0
    title
    Change between baseline and week 12
denoms
  1. counts
    1. group Id
      OG000
      value
      50
    2. group Id
      OG001
      value
      11
    units
    Participants
description
Vaginal cytology sample to evaluate the vaginal Maturation Value. For the cytologic evaluation, the number of parabasal, intermediate and superficial cells will be calculated in duplicate on 100 consecutive cells of vaginal cytology. The average of the two percentages obtained for each cell type will be calculated, which will serve to determine the maturation value (MV) based on the following formula: 0.2 x (% parabasal) + 0.6 x (% intermediate) + 1.0 x (% superficial).
dispersion Type
Inter-Quartile Range
groups
  1. description
    Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration
    id
    OG000
    title
    0.005% Estriol Vaginal Gel
  2. description
    Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration Placebo
    id
    OG001
    title
    Placebo Vaginal Gel
param Type
MEDIAN
population Description
postmenopausal women
reporting Status
POSTED
time Frame
week 3 and week 12 vs baseline
title
Changes in Vaginal Maturation Value
type
SECONDARY
unit Of Measure
% of cells

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

Preserved source evidence · Not medical advice