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NCT02413008 · OUTCOME

Changes in Fragility of the Mucosa [Time Frame: Week 3 and Week 12 vs Baseline]

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
score on a scale
Interval / dispersion
Inter-Quartile Range
Time frame
from baseline to week 3 and 12

What was measured

It will be scored by the investigator on a numerical scale in accordance with their presence and degree of severity as follows: 0 Absence. The sign is not present. 1. The sign is present and is considered a mild alteration 2. The sign is present and is considered a moderate alteration 3. The sign is present and is considered a severe alteration

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

Changes from baseline to week 3
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
0.005% Estriol Vaginal Gel1.0Not reported0.02.0Not reported
Placebo Vaginal Gel0.0Not reported0.01.0Not reported
Changes from baseline to week 12
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
0.005% Estriol Vaginal Gel1.5Not reported1.02.0Not reported
Placebo Vaginal Gel0.5Not reported0.01.0Not reported

Source statistical analyses

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

  1. group Description
    Changes in dryness of the mucosa between baseline and week 3
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.13
    statistical Method
    Wilcoxon (Mann-Whitney)
  2. group Description
    Changes in dryness of the mucosa between baseline and week 12
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    <0.01
    statistical Method
    Wilcoxon (Mann-Whitney)
Complete source fields
analyses
  1. group Description
    Changes in dryness of the mucosa between baseline and week 3
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.13
    statistical Method
    Wilcoxon (Mann-Whitney)
  2. group Description
    Changes in dryness of the mucosa between baseline and week 12
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    <0.01
    statistical Method
    Wilcoxon (Mann-Whitney)
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        2.0
        value
        1.0
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        1.0
        value
        0.0
    title
    Changes from baseline to week 3
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.0
        upper Limit
        2.0
        value
        1.5
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        1.0
        value
        0.5
    title
    Changes from baseline to week 12
denoms
  1. counts
    1. group Id
      OG000
      value
      50
    2. group Id
      OG001
      value
      11
    units
    Participants
description
It will be scored by the investigator on a numerical scale in accordance with their presence and degree of severity as follows: 0 Absence. The sign is not present. 1. The sign is present and is considered a mild alteration 2. The sign is present and is considered a moderate alteration 3. The sign is present and is considered a severe alteration
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
from baseline to week 3 and 12
title
Changes in Fragility of the Mucosa [Time Frame: Week 3 and Week 12 vs Baseline]
type
SECONDARY
unit Of Measure
score on a scale

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

Preserved source evidence · Not medical advice