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NCT02413008 · OUTCOME

Variation in Serum Levels of Luteinizing Hormone (LH)

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
mIU/ml
Interval / dispersion
Inter-Quartile Range
Time frame
Change from baseline to week 1, week 3, week 8 and week 12

What was measured

Change from (mean screening-baseline) in plasma levels of LH to Week 1, Week 3, Week 8 and Week 12 in Serum Levels of LH 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

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 from LH baseline to week 1
Values in mIU/ml · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
0.005% Estriol Vaginal Gel-0.6Not reported-3.72.8Not reported
Placebo Vaginal Gel0.2Not reported-1.88.1Not reported
change from LH baseline to week 3
Values in mIU/ml · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
0.005% Estriol Vaginal Gel-0.5Not reported-4.13.5Not reported
Placebo Vaginal Gel0.3Not reported-1.87.7Not reported
change from LH baseline to week 8
Values in mIU/ml · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
0.005% Estriol Vaginal Gel-0.3Not reported-4.93.1Not reported
Placebo Vaginal Gel-1.3Not reported-2.06.0Not reported
change from LH baseline to week 12
Values in mIU/ml · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
0.005% Estriol Vaginal Gel-0.8Not reported-5.32.9Not reported
Placebo Vaginal Gel1.3Not reported-1.67.1Not reported

Source statistical analyses

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

  1. group Description
    Change in serum levels of Luteinizing hormone (LH) from baseline to week 1
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    >0.05
    statistical Method
    Dunn Test
  2. group Description
    Change in serum levels of Luteinizing hormone (LH) from baseline to week 3
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    >0.05
    statistical Method
    Dunn Test
  3. group Description
    Change in serum levels of Luteinizing hormone (LH) from baseline to week 8
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    >0.05
    statistical Method
    Dunn Test
  4. group Description
    Change in serum levels of Luteinizing hormone (LH) from baseline to week 12
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.135
    statistical Method
    Wilcoxon (Mann-Whitney)
Complete source fields
analyses
  1. group Description
    Change in serum levels of Luteinizing hormone (LH) from baseline to week 1
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    >0.05
    statistical Method
    Dunn Test
  2. group Description
    Change in serum levels of Luteinizing hormone (LH) from baseline to week 3
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    >0.05
    statistical Method
    Dunn Test
  3. group Description
    Change in serum levels of Luteinizing hormone (LH) from baseline to week 8
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    >0.05
    statistical Method
    Dunn Test
  4. group Description
    Change in serum levels of Luteinizing hormone (LH) from baseline to week 12
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.135
    statistical Method
    Wilcoxon (Mann-Whitney)
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -3.7
        upper Limit
        2.8
        value
        -0.6
      2. group Id
        OG001
        lower Limit
        -1.8
        upper Limit
        8.1
        value
        0.2
    title
    change from LH baseline to week 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -4.1
        upper Limit
        3.5
        value
        -0.5
      2. group Id
        OG001
        lower Limit
        -1.8
        upper Limit
        7.7
        value
        0.3
    title
    change from LH baseline to week 3
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -4.9
        upper Limit
        3.1
        value
        -0.3
      2. group Id
        OG001
        lower Limit
        -2.0
        upper Limit
        6.0
        value
        -1.3
    title
    change from LH baseline to week 8
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -5.3
        upper Limit
        2.9
        value
        -0.8
      2. group Id
        OG001
        lower Limit
        -1.6
        upper Limit
        7.1
        value
        1.3
    title
    change from LH baseline to week 12
denoms
  1. counts
    1. group Id
      OG000
      value
      50
    2. group Id
      OG001
      value
      11
    units
    Participants
description
Change from (mean screening-baseline) in plasma levels of LH to Week 1, Week 3, Week 8 and Week 12 in Serum Levels of LH 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
    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
Change from baseline to week 1, week 3, week 8 and week 12
title
Variation in Serum Levels of Luteinizing Hormone (LH)
type
SECONDARY
unit Of Measure
mIU/ml

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Preserved source evidence · Not medical advice