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NCT00451958 · OUTCOME

Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56

A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy · Source last updated 2013-03-21

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

Measure
MEDIAN
Unit
International units/Liter (IU/L)
Interval / dispersion
Full Range
Time frame
From time of switch to Day 56

Analysis population: All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.

Groups in this outcome

Leuprolide 7.5 mg/ Degarelix 240/80 mg

During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.

Leuprolide 7.5 mg/ Degarelix 240/160 mg

During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.

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

Analysis denominator · Participants

GroupSource count
Leuprolide 7.5 mg/ Degarelix 240/80 mg69
Leuprolide 7.5 mg/ Degarelix 240/160 mg65

Reported measurements

Baseline
Values in International units/Liter (IU/L) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Leuprolide 7.5 mg/ Degarelix 240/80 mg4.8Not reported1.215.8Not reported
Leuprolide 7.5 mg/ Degarelix 240/160 mg4.4Not reported1.512.2Not reported
Day 3
Values in International units/Liter (IU/L) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Leuprolide 7.5 mg/ Degarelix 240/80 mg2.7Not reported0.811.1Not reported
Leuprolide 7.5 mg/ Degarelix 240/160 mg2.8Not reported0.57.6Not reported
Day 7
Values in International units/Liter (IU/L) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Leuprolide 7.5 mg/ Degarelix 240/80 mg2.6Not reported0.711.8Not reported
Leuprolide 7.5 mg/ Degarelix 240/160 mg2.6Not reported0.46.9Not reported
Day 14
Values in International units/Liter (IU/L) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Leuprolide 7.5 mg/ Degarelix 240/80 mg2.2Not reported0.157.9Not reported
Leuprolide 7.5 mg/ Degarelix 240/160 mg2.3Not reported0.158.3Not reported
Day 28
Values in International units/Liter (IU/L) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Leuprolide 7.5 mg/ Degarelix 240/80 mg1.8Not reported0.157.6Not reported
Leuprolide 7.5 mg/ Degarelix 240/160 mg1.7Not reported0.156.7Not reported
Day 56
Values in International units/Liter (IU/L) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Leuprolide 7.5 mg/ Degarelix 240/80 mg1.3Not reported0.156.7Not reported
Leuprolide 7.5 mg/ Degarelix 240/160 mg1.55Not reported0.155.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.2
        upper Limit
        15.8
        value
        4.8
      2. group Id
        OG001
        lower Limit
        1.5
        upper Limit
        12.2
        value
        4.4
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.8
        upper Limit
        11.1
        value
        2.7
      2. group Id
        OG001
        lower Limit
        0.5
        upper Limit
        7.6
        value
        2.8
    title
    Day 3
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.7
        upper Limit
        11.8
        value
        2.6
      2. group Id
        OG001
        lower Limit
        0.4
        upper Limit
        6.9
        value
        2.6
    title
    Day 7
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.15
        upper Limit
        7.9
        value
        2.2
      2. group Id
        OG001
        lower Limit
        0.15
        upper Limit
        8.3
        value
        2.3
    title
    Day 14
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.15
        upper Limit
        7.6
        value
        1.8
      2. group Id
        OG001
        lower Limit
        0.15
        upper Limit
        6.7
        value
        1.7
    title
    Day 28
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.15
        upper Limit
        6.7
        value
        1.3
      2. group Id
        OG001
        lower Limit
        0.15
        upper Limit
        5.6
        value
        1.55
    title
    Day 56
denoms
  1. counts
    1. group Id
      OG000
      value
      69
    2. group Id
      OG001
      value
      65
    units
    Participants
dispersion Type
Full Range
groups
  1. description
    During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
    id
    OG000
    title
    Leuprolide 7.5 mg/ Degarelix 240/80 mg
  2. description
    During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
    id
    OG001
    title
    Leuprolide 7.5 mg/ Degarelix 240/160 mg
param Type
MEDIAN
population Description
All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.
reporting Status
POSTED
time Frame
From time of switch to Day 56
title
Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56
type
SECONDARY
unit Of Measure
International units/Liter (IU/L)

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

Preserved source evidence · Not medical advice