Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486

This study has been completed.

Sponsor:

Information provided by:

Ferring Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00117949

First received: June 30, 2005

Last updated: May 18, 2011

Last verified: May 2011

History of Changes

Results First Received: January 22, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Prostate Cancer
Intervention:	Drug: Degarelix

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The patients were followed until they met a pre-defined criterion for insufficient testosterone or prostate-specific antigen (PSA).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Degarelix 40 mg	Degarelix 40 mg (10 mg/mL)
Degarelix 80 mg	Degarelix 80 mg (20 mg/mL)
Degarelix 120 mg	Degarelix 120 mg (30 mg/mL)
Degarelix 160 mg	Degarelix 160 mg (40 mg/mL)

Participant Flow: Overall Study

	Degarelix 40 mg	Degarelix 80 mg	Degarelix 120 mg	Degarelix 160 mg
STARTED	10 ^[1]	24	24	24
COMPLETED	0	0	0	0
NOT COMPLETED	10	24	24	24
Testosterone >1.0 ng/mL	10	18	17	15
Testosterone 0.5 - 1.0 ng/mL	0	1	3	2
Prostate-specific antigen increase >=25%	0	1	1	2
PSA increase >=10ng/mL	0	1	1	0
PSA reduction <=50%	0	2	2	4
Hepatic abnormalities	0	1	0	1

^[1]	Dose level terminated prematurely due to inadequate testosterone response

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Degarelix 40 mg	Degarelix 40 mg (10 mg/mL)
Degarelix 80 mg	Degarelix 80 mg (20 mg/mL)
Degarelix 120 mg	Degarelix 120 mg (30 mg/mL)
Degarelix 160 mg	Degarelix 160 mg (40 mg/mL)
Total	Total of all reporting groups

Baseline Measures

Degarelix 40 mg

Degarelix 80 mg

Degarelix 120 mg

Degarelix 160 mg

Total

Overall Participants Analyzed
[Units: Participants]

Age
[Units: Participants]

<=18 years

Between 18 and 65 years

>=65 years

Age
[Units: Years]
Mean (Standard Deviation)

72.0 (5.7)

77.5 (6.4)

75.9 (5.8)

74.7 (8.4)

75.6 (6.9)

Gender
[Units: Participants]

Female

Male

Race/Ethnicity, Customized
[Units: Participants]

Oriental/Asian

Black

Caucasian

Other

Gleason score ^[1]
[Units: Participants]

Unknown

2-4

5-6

7-10

^[1]	The Gleason score is a system of grading the aggressiveness of the prostate cancer and how fast it is likely to grow and spread. Scale is 2-10, with low numbers being the least aggressive and 10 being the most aggressive.

Stage of prostate cancer ^[1]
[Units: Participants]

Localized

Locally advanced

Metastatic

Not classifiable

^[1]	Prostate cancer stage was classified to describe the extent of cancer. Localized refers to tumors without involvement of lymph nodes or metastasis. Advanced localized can be larger tumors that may involve the lymph nodes but no metastasis. Metastatic are more advanced cancers that are spreading beyond the original tumor.

Body mass index ^[1]
[Units: Kilogram per square meter]
Mean (Standard Deviation)

26.70 (5.72)

26.61 (3.55)

27.22 (3.16)

26.64 (3.38)

26.70 (5.72)

^[1]	Body mass index is a measure of body fat based on height and weight.

Serum prostate-specific antigen levels
[Units: Nanogram per milliliter]
Median (Full Range)

9.30
(2.3 to 36.3)

13.40
(3.6 to 765)

9.10
(2.2 to 50.9)

6.40
(2.2 to 154)

9.35
(2.2 to 765)

Serum testosterone levels
[Units: Nanogram per milliliter]
Median (Full Range)

3.98
(2.29 to 5.31)

4.10
(1.79 to 8.53)

3.96
(2.02 to 7.22)

3.89
(1.79 to 8.53)

3.93
(1.79 to 8.53)

Time since prostate cancer diagnosis ^[1]
[Units: Days]
Mean (Standard Deviation)

851 (1077)

954 (1328)

1609 (1836)

1095 (1385)

1181 (1494)

^[1]	The mean number of days since a diagnosis of prostate cancer was made for the patients in each study group.

Weight
[Units: Kilogram]
Mean (Standard Deviation)

78.97 (11.73)

81.73 (11.50)

80.77 (12.83)

81.40 (14.36)

81.01 (12.61)

Outcome Measures

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1. Primary:

Time to Meet Insufficient Testosterone Response [ Time Frame: 3 months ]

Measure Type	Primary
Measure Title	Time to Meet Insufficient Testosterone Response
Measure Description	Figures in the table are Kaplan-Meier estimates of the time to meeting insufficient testosterone response. Insufficient testosterone response was defined as testosterone >1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits.
Time Frame	3 months

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients who withdrew without meeting the insufficient testosterone (T) suppression criteria were censored as of the time for last available T measurement prior to discontinuation. For the 40 mg group the 95% confidence interval around the time estimate was non-estimable and no statistical analysis is presented (the estimate was 14 days).

Reporting Groups

	Description
Degarelix 40 mg	Degarelix 40 mg (10 mg/mL)
Degarelix 80 mg	Degarelix 80 mg (20 mg/mL)
Degarelix 120 mg	Degarelix 120 mg (30 mg/mL)
Degarelix 160 mg	Degarelix 160 mg (40 mg/mL)

Measured Values

	Degarelix 40 mg	Degarelix 80 mg	Degarelix 120 mg	Degarelix 160 mg
Participants Analyzed [Units: Participants]	10	24	24	24
Time to Meet Insufficient Testosterone Response [Units: Days] Median (Full Range)	14 (14 to 70)	77 (14 to 140)	98 (14 to 219)	28 (14 to 126)

Statistical Analysis 1 for Time to Meet Insufficient Testosterone Response

Groups ^[1]	All groups
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	Log Rank
P Value ^[4]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Time to Meet Insufficient Testosterone Response

Groups ^[1]	Degarelix 80 mg
Statistical Test Type ^[2]	Superiority or Other
Median days to insufficient T response ^[3]	84
95% Confidence Interval	35 to 112

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Kaplan-Meier estimates of the time to meet insufficient testosterone (T) response.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Time to Meet Insufficient Testosterone Response

Groups ^[1]	Degarelix 120 mg
Statistical Test Type ^[2]	Superiority or Other
Median days to insufficient T response ^[3]	98
95% Confidence Interval	70 to 126

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Kaplan-Meier estimates of the time to meet insufficient testosterone (T) response
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for Time to Meet Insufficient Testosterone Response

Groups ^[1]	Degarelix 160 mg
Statistical Test Type ^[2]	Superiority or Other
Median days to insufficient T response ^[3]	35
95% Confidence Interval	14 to 98

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Kaplan-Meier estimates of the time to meet insufficient testosterone (T) response
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant estimation information:
	No text entered.

2. Primary:

Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days [ Time Frame: 28 days ]

Measure Type	Primary
Measure Title	Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days
Measure Description	The number of participants suppressed for at least 28 days was defined as the estimated "survival probability" at time=Day 28.
Time Frame	28 days

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Degarelix 40 mg	Degarelix 40 mg (10 mg/mL)
Degarelix 80 mg	Degarelix 80 mg (20 mg/mL)
Degarelix 120 mg	Degarelix 120 mg (30 mg/mL)
Degarelix 160 mg	Degarelix 160 mg (40 mg/mL)

Measured Values

	Degarelix 40 mg	Degarelix 80 mg	Degarelix 120 mg	Degarelix 160 mg
Participants Analyzed [Units: Participants]	10	24	24	24
Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days [Units: Participants]	1	17	19	13

Statistical Analysis 1 for Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days

Groups ^[1]	All groups
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	Cochran-Armitage Trend Test.
P Value ^[4]	0.181

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days

Groups ^[1]	Degarelix 40 mg
Statistical Test Type ^[2]	Superiority or Other
Percentage of participants ^[3]	10
95% Confidence Interval	0.3 to 44.5

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days

Groups ^[1]	Degarelix 80 mg
Statistical Test Type ^[2]	Superiority or Other
Percentage of participants ^[3]	70.8
95% Confidence Interval	48.9 to 87.4

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days

Groups ^[1]	Degarelix 120 mg
Statistical Test Type ^[2]	Superiority or Other
Percentage of participants ^[3]	79.2
95% Confidence Interval	57.8 to 92.9

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant estimation information:
	No text entered.

Statistical Analysis 5 for Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days

Groups ^[1]	Degarelix 160 mg
Statistical Test Type ^[2]	Superiority or Other
Percentage of participants ^[3]	54.2
95% Confidence Interval	32.8 to 74.4

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant estimation information:
	No text entered.

3. Secondary:

Time to Testosterone Castration (Testosterone ≤0.5 ng/mL). [ Time Frame: 1, 3, 7, 14, 21, 28, 42 days ]

Measure Type	Secondary
Measure Title	Time to Testosterone Castration (Testosterone ≤0.5 ng/mL).
Measure Description	Time to testosterone castration was calculated as the number of days from dosing to the first scheduled visit when testosterone was less than 0.5 ng/mL. The figures in the table present the number of participants who were castrated after 1, 3, 7, 14, 21, 28, and 42 days.
Time Frame	1, 3, 7, 14, 21, 28, 42 days

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Half participants in the 40 mg group were not castrated and the median was not calculated (no statistical anaylsis was made). Two participants out of 24 in the 80 mg, 1/24 in the 120 mg, and 3/24 in the 160 mg groups were not castrated. For the 160 mg group the 95% CI was non-estimable and no statistical anaylsis was made.

Reporting Groups

	Description
Degarelix 40 mg	Degarelix 40 mg (10 mg/mL)
Degarelix 80 mg	Degarelix 80 mg (20 mg/mL)
Degarelix 120 mg	Degarelix 120 mg (30 mg/mL)
Degarelix 160 mg	Degarelix 160 mg (40 mg/mL)

Measured Values

	Degarelix 40 mg	Degarelix 80 mg	Degarelix 120 mg	Degarelix 160 mg
Participants Analyzed [Units: Participants]	10	24	24	24
Time to Testosterone Castration (Testosterone ≤0.5 ng/mL). [Units: Days]
1 day	1	3	11	6
3 days	3	12	12	14
7 days	1	2	0	1
14 days	0	2	0	0
21 days	0	1	0	0
28 days	0	1	0	0
42 days	0	1	0	0

Statistical Analysis 1 for Time to Testosterone Castration (Testosterone ≤0.5 ng/mL).

Groups ^[1]	All groups
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	Log Rank
P Value ^[4]	0.003

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	Participants not castrated were censored as of the days from dosing for the last available observation.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Time to Testosterone Castration (Testosterone ≤0.5 ng/mL).

Groups ^[1]	Degarelix 80 mg
Statistical Test Type ^[2]	Superiority or Other
Median time to castration (days) ^[3]	3
95% Confidence Interval	3 to 7

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Kaplan-Meier estimates of the median time to testosterone castration.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Time to Testosterone Castration (Testosterone ≤0.5 ng/mL).

Groups ^[1]	Degarelix 120 mg
Statistical Test Type ^[2]	Superiority or Other
Median time to castration (days) ^[3]	3
95% Confidence Interval	1 to 3

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Kaplan-Meier estimates of the time to testosterone castration.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant estimation information:
	No text entered.

4. Secondary:

Number of Participants With Sufficient Testosterone Suppression for at Least 84 Days [ Time Frame: 3 months ]

Measure Type	Secondary
Measure Title	Number of Participants With Sufficient Testosterone Suppression for at Least 84 Days
Measure Description	Sufficient testosterone suppression was defined as not meeting an insufficient testosterone response criterion. Insufficient testosterone response was defined as testosterone >1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits.
Time Frame	3 months

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Degarelix 40 mg	Degarelix 40 mg (10 mg/mL)
Degarelix 80 mg	Degarelix 80 mg (20 mg/mL)
Degarelix 120 mg	Degarelix 120 mg (30 mg/mL)
Degarelix 160 mg	Degarelix 160 mg (40 mg/mL)

Measured Values

	Degarelix 40 mg	Degarelix 80 mg	Degarelix 120 mg	Degarelix 160 mg
Participants Analyzed [Units: Participants]	10	24	24	24
Number of Participants With Sufficient Testosterone Suppression for at Least 84 Days [Units: Participants]	0	9	14	7

Statistical Analysis 1 for Number of Participants With Sufficient Testosterone Suppression for at Least 84 Days

Groups ^[1]	Degarelix 40 mg
Statistical Test Type ^[2]	Superiority or Other
Percentage of participants ^[3]	0
95% Confidence Interval	0 to 0

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Number of Participants With Sufficient Testosterone Suppression for at Least 84 Days

Groups ^[1]	Degarelix 80 mg
Statistical Test Type ^[2]	Superiority or Other
Percentage of participants ^[3]	42.7
95% Confidence Interval	22 to 63.4

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Number of Participants With Sufficient Testosterone Suppression for at Least 84 Days

Groups ^[1]	Degarelix 120 mg
Statistical Test Type ^[2]	Superiority or Other
Percentage of participants ^[3]	61.6
95% Confidence Interval	41.8 to 81.3

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for Number of Participants With Sufficient Testosterone Suppression for at Least 84 Days

Groups ^[1]	Degarelix 160 mg
Statistical Test Type ^[2]	Superiority or Other
Percentage of participants ^[3]	35.6
95% Confidence Interval	15.8 to 55.5

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant estimation information:
	No text entered.

5. Secondary:

Time to 50% Reduction in Prostate-specific Antigen Levels [ Time Frame: 3 months ]

Measure Type	Secondary
Measure Title	Time to 50% Reduction in Prostate-specific Antigen Levels
Measure Description	The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the median number of days from dosing to the first visit where a 50% reduction in PSA level was reached.
Time Frame	3 months

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation. In the 40 mg group only two participants reached a 50% reduction in PSA and the Kaplan-Meier estimate could not be calculated (ie no statistical analysis is presented for this group).

Reporting Groups

	Description
Degarelix 40 mg	Degarelix 40 mg (10 mg/mL)
Degarelix 80 mg	Degarelix 80 mg (20 mg/mL)
Degarelix 120 mg	Degarelix 120 mg (30 mg/mL)
Degarelix 160 mg	Degarelix 160 mg (40 mg/mL)

Measured Values

	Degarelix 40 mg	Degarelix 80 mg	Degarelix 120 mg	Degarelix 160 mg
Participants Analyzed [Units: Participants]	10	24	24	24
Time to 50% Reduction in Prostate-specific Antigen Levels [Units: Days] Median (Full Range)	10.5 (7 to 14)	14 (7 to 42)	14 (7 to 35)	14 (7 to 42)

Statistical Analysis 1 for Time to 50% Reduction in Prostate-specific Antigen Levels

Groups ^[1]	All groups
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	Log Rank
P Value ^[4]	0.046

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Time to 50% Reduction in Prostate-specific Antigen Levels

Groups ^[1]	Degarelix 80 mg
Statistical Test Type ^[2]	Superiority or Other
days ^[3]	14
95% Confidence Interval	14 to 28

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Kaplan-Meier estimates of the time (days) to 50% reduction in PSA
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Time to 50% Reduction in Prostate-specific Antigen Levels

Groups ^[1]	Degarelix 120 mg
Statistical Test Type ^[2]	Superiority or Other
days ^[3]	14
95% Confidence Interval	14 to 28

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Kaplan-Meier estimates of the time (days) to 50% reduction in PSA
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for Time to 50% Reduction in Prostate-specific Antigen Levels

Groups ^[1]	Degarelix 160 mg
Statistical Test Type ^[2]	Superiority or Other
days ^[3]	28
95% Confidence Interval	14 to 41

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Kaplan-Meier estimates of the time (days) to 50% reduction in PSA
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant estimation information:
	No text entered.

6. Secondary:

Time to 90% Reduction in Prostate-specific Antigen Levels [ Time Frame: 3 months ]

Measure Type	Secondary
Measure Title	Time to 90% Reduction in Prostate-specific Antigen Levels
Measure Description	The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the median number of days from dosing to the first visit where a 90% reduction in PSA level was reached.
Time Frame	3 months

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation. In the 40 mg group only one participant reached a 90% reduction in PSA and the Kaplan-Meier estimate could not be calculated (ie no statistical analysis is presented for this group).

Reporting Groups

	Description
Degarelix 40 mg	Degarelix 40 mg (10 mg/mL)
Degarelix 80 mg	Degarelix 80 mg (20 mg/mL)
Degarelix 120 mg	Degarelix 120 mg (30 mg/mL)
Degarelix 160 mg	Degarelix 160 mg (40 mg/mL)

Measured Values

	Degarelix 40 mg	Degarelix 80 mg	Degarelix 120 mg	Degarelix 160 mg
Participants Analyzed [Units: Participants]	10	24	24	24
Time to 90% Reduction in Prostate-specific Antigen Levels [Units: Days] Median (Full Range)	28 (28 to 28)	35 (28 to 98)	35 (28 to 84)	31.5 (14 to 56)

Statistical Analysis 1 for Time to 90% Reduction in Prostate-specific Antigen Levels

Groups ^[1]	All groups
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	Log Rank
P Value ^[4]	0.926

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Time to 90% Reduction in Prostate-specific Antigen Levels

Groups ^[1]	Degarelix 80 mg
Statistical Test Type ^[2]	Superiority or Other
days ^[3]	56
95% Confidence Interval	35 to 56

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Kaplan-Meier estimates of the time (days) to 90% reduction in PSA.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Time to 90% Reduction in Prostate-specific Antigen Levels

Groups ^[1]	Degarelix 120 mg
Statistical Test Type ^[2]	Superiority or Other
days ^[3]	56
95% Confidence Interval	35 to 84

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Kaplan-Meier estimates of the time (days) to 90% reduction in PSA.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for Time to 90% Reduction in Prostate-specific Antigen Levels

Groups ^[1]	Degarelix 160 mg
Statistical Test Type ^[2]	Superiority or Other
days ^[3]	56
95% Confidence Interval	35 to 100

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Kaplan-Meier estimates of the time (days) to 90% reduction in PSA.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant estimation information:
	The upper confidence interval limit could not be calculated. For technical reasons it has been entered as 100.

7. Secondary:

Liver Function Tests [ Time Frame: 3 months ]

Measure Type	Secondary
Measure Title	Liver Function Tests
Measure Description	The number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferas levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.
Time Frame	3 months

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Degarelix 40 mg	Degarelix 40 mg (10 mg/mL)
Degarelix 80 mg	Degarelix 80 mg (20 mg/mL)
Degarelix 120 mg	Degarelix 120 mg (30 mg/mL)
Degarelix 160 mg	Degarelix 160 mg (40 mg/mL)

Measured Values

	Degarelix 40 mg	Degarelix 80 mg	Degarelix 120 mg	Degarelix 160 mg
Participants Analyzed [Units: Participants]	10	24	24	24
Liver Function Tests [Units: Participants]
Abnormal alanine aminotransferase (ALAT)	0	3	3	6
Abnormal aspartate aminotransferase	1	11	13	9
Abnormal bilirubin	2	0	2	2
ALAT >3x upper limit of normal (ULN)	0	1	0	0
ALAT >3x ULN, bilirubin >1.5x ULN	0	0	0	0

No statistical analysis provided for Liver Function Tests

Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript.

Results Point of Contact:

Name/Title: Clinical Development Support
Organization: Ferring Pharmaceuticals
e-mail: DK0-Disclosure@ferring.com

Responsible Party:	Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00117949 History of Changes
Other Study ID Numbers:	FE200486 CS06
Study First Received:	June 30, 2005
Results First Received:	January 22, 2009
Last Updated:	May 18, 2011

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