Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486

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
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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

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.
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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]	10	24	24	24	82
Age  [Units: Participants]
<=18 years	0	0	0	0	0
Between 18 and 65 years	1	1	2	4	8
>=65 years	9	23	22	20	74
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	0	0	0	0	0
Male	10	24	24	24	82
Race/Ethnicity, Customized  [Units: Participants]
Oriental/Asian	0	0	0	0	0
Black	2	1	2	1	6
Caucasian	5	23	15	20	63
Other	3	0	7	3	13
Gleason score [1]  [Units: Participants]
Unknown	0	1	0	0	1
2-4	1	1	1	0	3
5-6	3	14	12	13	42
7-10	6	8	11	11	36
[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	5	11	12	10	38
Locally advanced	0	6	5	5	16
Metastatic	2	4	2	2	10
Not classifiable	3	3	5	7	18
[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)

1.  Primary:

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

2.  Primary:

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

3.  Secondary:

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

4.  Secondary:

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

5.  Secondary:

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

6.  Secondary:

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

7.  Secondary:

Liver Function Tests   [ Time Frame: 3 months ]

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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