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NCT02413008 · OUTCOME

Variation in Serum Levels of FSH at Week 1, Week 3 and Week 8

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
MEAN
Unit
mIU/ml
Interval / dispersion
Inter-Quartile Range
Time frame
Change from baseline to week 1, week 3 and week 8

What was measured

Change from Baseline (mean screening-baseline) to Week 1, Week 3 and Week 8 in Serum Levels of Follicle Stimulating Hormone (FSH) compare to natural physiological variability ( screening-baseline variation)

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 estriol: 0.005% estriol vaginal gel

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: placebo vaginal gel

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 from baseline to week 1
Values in mIU/ml · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
0.005% Estriol Vaginal Gel-4.8Not reported-11.62.6Not reported
Placebo Vaginal Gel4.2Not reported-7.87.3Not reported
change from baseline to week 3
Values in mIU/ml · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
0.005% Estriol Vaginal Gel-4.2Not reported-12.03.5Not reported
Placebo Vaginal Gel-0.9Not reported-4.02.3Not reported
change from baseline to week 8
Values in mIU/ml · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
0.005% Estriol Vaginal Gel-2.6Not reported-10.17.9Not reported
Placebo Vaginal Gel5.2Not reported-11.89Not reported

Source statistical analyses

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

  1. group Description
    Variation in serum levels of FSH at week 1
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    <0.05
    statistical Method
    Dunn Test
  2. group Description
    Variation in serum levels of FSH at week 3
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    <0.05
    statistical Method
    Dunn Test
  3. group Description
    Variation in serum levels of FSH at week 8
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    >0.05
    statistical Method
    Dunn Test
Complete source fields
analyses
  1. group Description
    Variation in serum levels of FSH at week 1
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    <0.05
    statistical Method
    Dunn Test
  2. group Description
    Variation in serum levels of FSH at week 3
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    <0.05
    statistical Method
    Dunn Test
  3. group Description
    Variation in serum levels of FSH at week 8
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    >0.05
    statistical Method
    Dunn Test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -11.6
        upper Limit
        2.6
        value
        -4.8
      2. group Id
        OG001
        lower Limit
        -7.8
        upper Limit
        7.3
        value
        4.2
    title
    change from baseline to week 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -12.0
        upper Limit
        3.5
        value
        -4.2
      2. group Id
        OG001
        lower Limit
        -4.0
        upper Limit
        2.3
        value
        -0.9
    title
    change from baseline to week 3
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -10.1
        upper Limit
        7.9
        value
        -2.6
      2. group Id
        OG001
        lower Limit
        -11.8
        upper Limit
        9
        value
        5.2
    title
    change from baseline to week 8
denoms
  1. counts
    1. group Id
      OG000
      value
      50
    2. group Id
      OG001
      value
      11
    units
    Participants
description
Change from Baseline (mean screening-baseline) to Week 1, Week 3 and Week 8 in Serum Levels of Follicle Stimulating Hormone (FSH) compare to natural physiological variability ( screening-baseline variation)
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 estriol: 0.005% estriol vaginal gel
    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: placebo vaginal gel
    id
    OG001
    title
    Placebo Vaginal Gel
param Type
MEAN
population Description
postmenopausal women
reporting Status
POSTED
time Frame
Change from baseline to week 1, week 3 and week 8
title
Variation in Serum Levels of FSH at Week 1, Week 3 and Week 8
type
SECONDARY
unit Of Measure
mIU/ml

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

Preserved source evidence · Not medical advice