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NCT00931528 · OUTCOME

Partner Marital Adjustment as Measured by the Locke's Marital Adjustment Test

Tadalafil in Preventing Erectile Dysfunction in Patients With Prostate Cancer Treated With Radiation Therapy · Source last updated 2018-02-14

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

Measure
MEAN
Unit
change in LMAT score
Interval / dispersion
Standard Error
Time frame
Baseline, week 30 and years 1 and 2 after the start of treatment

What was measured

The Locke Marital Adjustment Test (LMAT) is a 16-item questionnaire with scores ranging from 48 to 138 for participants. Higher scores indicate greater sexual function, sexual wellbeing, or marital adjustment. The change in LMAT score is calculated by subtracting the baseline score from the follow-up score.

Analysis population: Consenting spouses of randomized, eligible patients with data at baseline and time point of interest

Groups in this outcome

Tadalafil

Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.

Placebo

Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 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
Tadalafil34
Placebo27

Reported measurements

Week 30

Analysis denominator · Participants

GroupSource count
Tadalafil19
Placebo12
Values in change in LMAT score · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Tadalafil-1.56.3Not reportedNot reportedNot reported
Placebo-2.66.4Not reportedNot reportedNot reported
Year 1

Analysis denominator · Participants

GroupSource count
Tadalafil16
Placebo12
Values in change in LMAT score · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Tadalafil-2.35.1Not reportedNot reportedNot reported
Placebo1.27.3Not reportedNot reportedNot reported
Year 2

Analysis denominator · Participants

GroupSource count
Tadalafil13
Placebo9
Values in change in LMAT score · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Tadalafil-2.85.8Not reportedNot reportedNot reported
Placebo-4.77.1Not reportedNot reportedNot reported

Source statistical analyses

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

  1. group Description
    Week 30
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.86
    statistical Comment
    Significance level = 0.05
    statistical Method
    t-test, 2 sided
  2. group Description
    Year 1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.93
    statistical Comment
    Significance level = 0.05
    statistical Method
    t-test, 2 sided
  3. group Description
    Year 2
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.52
    statistical Comment
    Significance level = 0.05
    statistical Method
    t-test, 2 sided
Complete source fields
analyses
  1. group Description
    Week 30
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.86
    statistical Comment
    Significance level = 0.05
    statistical Method
    t-test, 2 sided
  2. group Description
    Year 1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.93
    statistical Comment
    Significance level = 0.05
    statistical Method
    t-test, 2 sided
  3. group Description
    Year 2
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.52
    statistical Comment
    Significance level = 0.05
    statistical Method
    t-test, 2 sided
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.3
        value
        -1.5
      2. group Id
        OG001
        spread
        6.4
        value
        -2.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        12
      units
      Participants
    title
    Week 30
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.1
        value
        -2.3
      2. group Id
        OG001
        spread
        7.3
        value
        1.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        12
      units
      Participants
    title
    Year 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.8
        value
        -2.8
      2. group Id
        OG001
        spread
        7.1
        value
        -4.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        9
      units
      Participants
    title
    Year 2
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    2. group Id
      OG001
      value
      27
    units
    Participants
description
The Locke Marital Adjustment Test (LMAT) is a 16-item questionnaire with scores ranging from 48 to 138 for participants. Higher scores indicate greater sexual function, sexual wellbeing, or marital adjustment. The change in LMAT score is calculated by subtracting the baseline score from the follow-up score.
dispersion Type
Standard Error
groups
  1. description
    Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.
    id
    OG000
    title
    Tadalafil
  2. description
    Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
    id
    OG001
    title
    Placebo
param Type
MEAN
population Description
Consenting spouses of randomized, eligible patients with data at baseline and time point of interest
reporting Status
POSTED
time Frame
Baseline, week 30 and years 1 and 2 after the start of treatment
title
Partner Marital Adjustment as Measured by the Locke's Marital Adjustment Test
type
SECONDARY
unit Of Measure
change in LMAT score

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Preserved source evidence · Not medical advice