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NCT03085095 · OUTCOME

Follicle-stimulating Hormone (FSH) Level

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
IU/L
Interval / dispersion
Standard Deviation
Time frame
Week 25 Day 1 (Day 169)

What was measured

To evaluate the effect of relugolix and leuprolide acetate on FSH suppression.

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

Source class 1
Values in IU/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Relugolix1.721.376Not reportedNot reportedNot reported
Leuprolide Acetate5.953.071Not reportedNot reportedNot reported

Source statistical analyses

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

  1. group Description
    Alpha-protected statistical analysis.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.0001
    p Value Comment
    Statistically significance was met if p-value \< 0.05.
    statistical Comment
    Two-sided type I error rate of 0.05.
    statistical Method
    t-test, 2 sided
Complete source fields
analyses
  1. group Description
    Alpha-protected statistical analysis.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.0001
    p Value Comment
    Statistically significance was met if p-value \< 0.05.
    statistical Comment
    Two-sided type I error rate of 0.05.
    statistical Method
    t-test, 2 sided
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.376
        value
        1.72
      2. group Id
        OG001
        spread
        3.071
        value
        5.95
denoms
  1. counts
    1. group Id
      OG000
      value
      622
    2. group Id
      OG001
      value
      308
    units
    Participants
description
To evaluate the effect of relugolix and leuprolide acetate on FSH suppression.
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 25 Day 1 (Day 169)
title
Follicle-stimulating Hormone (FSH) Level
type
SECONDARY
unit Of Measure
IU/L

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

Preserved source evidence · Not medical advice