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NCT03085095 · OUTCOME

Change From Baseline In QoL Total Score As Assessed By The EORTC-QLQ-PR25 Sexual Activity And Functioning And Hormonal-Treatment-Related Symptom Subdomains

A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer · Source last updated 2022-01-18

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

Measure
MEAN
Unit
score on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline, Week 49 Day 1 (Day 337)

What was measured

Subscales for assessment of hormonal treatment-related symptoms (6 items) and sexual activity and function (6 items) from the EORTC-QLQ-PR25 25-item prostate cancer module of the EORTC are presented. Questions used 4 point scale (1 'Not at all' to 4 'Very much'). All raw domain scores are linearly transformed to a 0-100 scale. An increase in activity or functioning scores indicates improvement (higher/healthier level of functioning) and a decrease in symptom scores indicates improvement (lower level of symptoms/problems).

Analysis population: All randomized participants who received at least 1 dose of study drug and had analyzable data at the specified timepoint.

Groups in this outcome

Relugolix

Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.

Leuprolide Acetate

Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.

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

Analysis denominator · Participants

GroupSource count
Relugolix537
Leuprolide Acetate256

Reported measurements

Sexual activity
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Relugolix13.926.51Not reportedNot reportedNot reported
Leuprolide Acetate10.827.90Not reportedNot reportedNot reported
Sexual functioning
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Relugolix-9.023.37Not reportedNot reportedNot reported
Leuprolide Acetate-10.421.10Not reportedNot reportedNot reported
Hormonal treatment-related symptoms
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Relugolix10.612.25Not reportedNot reportedNot reported
Leuprolide Acetate11.413.30Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        26.51
        value
        13.9
      2. group Id
        OG001
        spread
        27.90
        value
        10.8
    title
    Sexual activity
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.37
        value
        -9.0
      2. group Id
        OG001
        spread
        21.10
        value
        -10.4
    title
    Sexual functioning
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.25
        value
        10.6
      2. group Id
        OG001
        spread
        13.30
        value
        11.4
    title
    Hormonal treatment-related symptoms
denoms
  1. counts
    1. group Id
      OG000
      value
      537
    2. group Id
      OG001
      value
      256
    units
    Participants
description
Subscales for assessment of hormonal treatment-related symptoms (6 items) and sexual activity and function (6 items) from the EORTC-QLQ-PR25 25-item prostate cancer module of the EORTC are presented. Questions used 4 point scale (1 'Not at all' to 4 'Very much'). All raw domain scores are linearly transformed to a 0-100 scale. An increase in activity or functioning scores indicates improvement (higher/healthier level of functioning) and a decrease in symptom scores indicates improvement (lower level of symptoms/problems).
dispersion Type
Standard Deviation
groups
  1. description
    Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
    id
    OG000
    title
    Relugolix
  2. description
    Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
    id
    OG001
    title
    Leuprolide Acetate
param Type
MEAN
population Description
All randomized participants who received at least 1 dose of study drug and had analyzable data at the specified timepoint.
reporting Status
POSTED
time Frame
Baseline, Week 49 Day 1 (Day 337)
title
Change From Baseline In QoL Total Score As Assessed By The EORTC-QLQ-PR25 Sexual Activity And Functioning And Hormonal-Treatment-Related Symptom Subdomains
type
SECONDARY
unit Of Measure
score on a scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice