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NCT03085095 · OUTCOME

Percent Change From Baseline In Serum Concentrations Of FSH

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
percent change
Interval / dispersion
Standard Deviation
Time frame
Week 1 Day 4 (Day 4), Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337)

What was measured

Blood samples were collected from participants for hormonal measurements.

Analysis population: All randomized participants who received at least 1 dose of study drug.

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
Relugolix622
Leuprolide Acetate308

Reported measurements

Week 1 Day 4 (Day 4)
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Relugolix-62.599.051Not reportedNot reportedNot reported
Leuprolide Acetate-4.7436.121Not reportedNot reportedNot reported
Week 5 Day 1 (Day 29)
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Relugolix-90.808.151Not reportedNot reportedNot reported
Leuprolide Acetate-67.7327.311Not reportedNot reportedNot reported
Week 25 Day 1 (Day 169)
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Relugolix-86.3210.699Not reportedNot reportedNot reported
Leuprolide Acetate-47.5332.560Not reportedNot reportedNot reported
Week 49 Day 1 (Day 337)
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Relugolix-79.3921.987Not reportedNot reportedNot reported
Leuprolide Acetate-47.2330.112Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.051
        value
        -62.59
      2. group Id
        OG001
        spread
        36.121
        value
        -4.74
    title
    Week 1 Day 4 (Day 4)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.151
        value
        -90.80
      2. group Id
        OG001
        spread
        27.311
        value
        -67.73
    title
    Week 5 Day 1 (Day 29)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.699
        value
        -86.32
      2. group Id
        OG001
        spread
        32.560
        value
        -47.53
    title
    Week 25 Day 1 (Day 169)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.987
        value
        -79.39
      2. group Id
        OG001
        spread
        30.112
        value
        -47.23
    title
    Week 49 Day 1 (Day 337)
denoms
  1. counts
    1. group Id
      OG000
      value
      622
    2. group Id
      OG001
      value
      308
    units
    Participants
description
Blood samples were collected from participants for hormonal measurements.
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.
reporting Status
POSTED
time Frame
Week 1 Day 4 (Day 4), Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337)
title
Percent Change From Baseline In Serum Concentrations Of FSH
type
SECONDARY
unit Of Measure
percent change

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

Preserved source evidence · Not medical advice