NCT00451958 · OUTCOME

Serum Levels of Luteinizing Hormone (LH) 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

Group	Source count
Leuprolide 7.5 mg/ Degarelix 240/80 mg	69
Leuprolide 7.5 mg/ Degarelix 240/160 mg	65

Reported measurements

Baseline

Values in International units/Liter (IU/L) · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Leuprolide 7.5 mg/ Degarelix 240/80 mg	0.035	Not reported	0.035	1.12	Not reported
Leuprolide 7.5 mg/ Degarelix 240/160 mg	0.035	Not reported	0.035	0.40	Not reported

Day 3

Values in International units/Liter (IU/L) · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Leuprolide 7.5 mg/ Degarelix 240/80 mg	0.035	Not reported	0.035	0.11	Not reported
Leuprolide 7.5 mg/ Degarelix 240/160 mg	0.035	Not reported	0.035	0.12	Not reported

Day 7

Values in International units/Liter (IU/L) · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Leuprolide 7.5 mg/ Degarelix 240/80 mg	0.035	Not reported	0.035	0.11	Not reported
Leuprolide 7.5 mg/ Degarelix 240/160 mg	0.035	Not reported	0.035	0.08	Not reported

Day 14

Values in International units/Liter (IU/L) · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Leuprolide 7.5 mg/ Degarelix 240/80 mg	0.035	Not reported	0.035	0.47	Not reported
Leuprolide 7.5 mg/ Degarelix 240/160 mg	0.035	Not reported	0.035	0.12	Not reported

Day 28

Values in International units/Liter (IU/L) · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Leuprolide 7.5 mg/ Degarelix 240/80 mg	0.035	Not reported	0.035	0.16	Not reported
Leuprolide 7.5 mg/ Degarelix 240/160 mg	0.035	Not reported	0.035	0.19	Not reported

Day 56

Values in International units/Liter (IU/L) · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Leuprolide 7.5 mg/ Degarelix 240/80 mg	0.035	Not reported	0.035	0.17	Not reported
Leuprolide 7.5 mg/ Degarelix 240/160 mg	0.035	Not reported	0.035	0.22	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.035
upper Limit
1.12
value
0.035
group Id
OG001
lower Limit
0.035
upper Limit
0.40
value
0.035
title
Baseline
categories
measurements
group Id
OG000
lower Limit
0.035
upper Limit
0.11
value
0.035
group Id
OG001
lower Limit
0.035
upper Limit
0.12
value
0.035
title
Day 3
categories
measurements
group Id
OG000
lower Limit
0.035
upper Limit
0.11
value
0.035
group Id
OG001
lower Limit
0.035
upper Limit
0.08
value
0.035
title
Day 7
categories
measurements
group Id
OG000
lower Limit
0.035
upper Limit
0.47
value
0.035
group Id
OG001
lower Limit
0.035
upper Limit
0.12
value
0.035
title
Day 14
categories
measurements
group Id
OG000
lower Limit
0.035
upper Limit
0.16
value
0.035
group Id
OG001
lower Limit
0.035
upper Limit
0.19
value
0.035
title
Day 28
categories
measurements
group Id
OG000
lower Limit
0.035
upper Limit
0.17
value
0.035
group Id
OG001
lower Limit
0.035
upper Limit
0.22
value
0.035
title
Day 56

denoms

counts
group Id
OG000
value
69
group Id
OG001
value
65
units
Participants

dispersion Type

Full Range

groups

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
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 Luteinizing Hormone (LH) 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