Trial Outcomes & Findings for Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Ablation Therapy (NCT NCT00468286)

NCT ID: NCT00468286

Last Updated: 2011-03-23

Results Overview

Kaplan-Maier estimates of the cumulative probabilities of testosterone \<=0.5 ng/mL from Day 28 to Day 364.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 133 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2011-03-23

Participant Flow

Participant milestones

Measure	Degarelix 240/360 mg Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.	Degarelix 240/480 mg Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.
Overall Study STARTED	67	66
Overall Study COMPLETED	60	54
Overall Study NOT COMPLETED	7	12

Reasons for withdrawal

Measure	Degarelix 240/360 mg Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.	Degarelix 240/480 mg Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.
Overall Study Adverse Event	1	6
Overall Study Protocol Violation	2	2
Overall Study Withdrawal by Subject	4	3
Overall Study Physician Decision	0	1

Baseline Characteristics

Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Ablation Therapy

Baseline characteristics by cohort

Measure	Degarelix 240/360 mg n=67 Participants Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.	Degarelix 240/480 mg n=66 Participants Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.	Total n=133 Participants Total of all reporting groups
Age Continuous	74.1 years STANDARD_DEVIATION 7.3 • n=5 Participants	72.7 years STANDARD_DEVIATION 8.5 • n=7 Participants	73.4 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	67 Participants n=5 Participants	66 Participants n=7 Participants	133 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	64 Participants n=5 Participants	63 Participants n=7 Participants	127 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Weight	78.9 kilogram STANDARD_DEVIATION 12.9 • n=5 Participants	82.4 kilogram STANDARD_DEVIATION 13.4 • n=7 Participants	80.6 kilogram STANDARD_DEVIATION 13.2 • n=5 Participants
Body mass index	27 kilogram per square meter STANDARD_DEVIATION 4.0 • n=5 Participants	27.4 kilogram per square meter STANDARD_DEVIATION 3.4 • n=7 Participants	27.2 kilogram per square meter STANDARD_DEVIATION 3.7 • n=5 Participants
Curative intent Yes	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants
Curative intent No	60 participants n=5 Participants	60 participants n=7 Participants	120 participants n=5 Participants
Gleason Score 2-4	8 participants n=5 Participants	3 participants n=7 Participants	11 participants n=5 Participants
Gleason Score 5-6	19 participants n=5 Participants	24 participants n=7 Participants	43 participants n=5 Participants
Gleason Score 7-10	39 participants n=5 Participants	39 participants n=7 Participants	78 participants n=5 Participants
Gleason Score Data missing	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Stage of Prostate Cancer Localized	26 participants n=5 Participants	19 participants n=7 Participants	45 participants n=5 Participants
Stage of Prostate Cancer Locally advanced	17 participants n=5 Participants	22 participants n=7 Participants	39 participants n=5 Participants
Stage of Prostate Cancer Metastatic	14 participants n=5 Participants	16 participants n=7 Participants	30 participants n=5 Participants
Stage of Prostate Cancer Not classifiable	10 participants n=5 Participants	9 participants n=7 Participants	19 participants n=5 Participants
Time Since Prostate Cancer Diagnosis	370 days STANDARD_DEVIATION 1011 • n=5 Participants	265 days STANDARD_DEVIATION 499 • n=7 Participants	319 days STANDARD_DEVIATION 802 • n=5 Participants
Serum Testosterone	4.1 ng/mL n=5 Participants	4.1 ng/mL n=7 Participants	4.1 ng/mL n=5 Participants
Serum PSA	22.9 ng/mL n=5 Participants	18.2 ng/mL n=7 Participants	20.3 ng/mL n=5 Participants
Serum FSH	8.4 IU/L n=5 Participants	6.9 IU/L n=7 Participants	7.0 IU/L n=5 Participants
Serum LH	5.9 IU/L n=5 Participants	4.6 IU/L n=7 Participants	5.3 IU/L n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 28 to Day 364.

Outcome measures

Measure	Degarelix 240/360 mg n=67 Participants Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.	Degarelix 240/480 mg n=66 Participants Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.
Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 28 Through Day 364	89.0 percentage of participants Interval 78.3 to 94.6	93.3 percentage of participants Interval 83.1 to 97.4

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	Degarelix 240/360 mg n=67 Participants Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.	Degarelix 240/480 mg n=66 Participants Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.
Serum Levels of Testosterone Over Time Day 28	0.1 ng/mL Interval 0.0 to 0.5	0.1 ng/mL Interval 0.0 to 4.6
Serum Levels of Testosterone Over Time Day 84	0.1 ng/mL Interval 0.0 to 0.4	0.1 ng/mL Interval 0.0 to 1.1
Serum Levels of Testosterone Over Time Day 364	0.1 ng/mL Interval 0.0 to 2.4	0.1 ng/mL Interval 0.0 to 0.7

SECONDARY outcome

Timeframe: 1 year

Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 56 to Day 364.

Outcome measures

Measure	Degarelix 240/360 mg n=67 Participants Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.	Degarelix 240/480 mg n=66 Participants Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.
Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 56 Through Day 364	89.0 percentage of participants Interval 78.3 to 94.6	93.3 percentage of participants Interval 83.0 to 97.4

SECONDARY outcome

Timeframe: 1 year

Cumulative probability (%) and 95% confidence interval (CI) for completing the study without PSA failure. PSA failure was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (lowest level of PSA achieved).

Outcome measures

Measure	Degarelix 240/360 mg n=67 Participants Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.	Degarelix 240/480 mg n=66 Participants Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.
Probability of no PSA Failure	93.5 percentage of participants Interval 83.6 to 97.5	94.6 percentage of participants Interval 84.3 to 98.2

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	Degarelix 240/360 mg n=67 Participants Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.	Degarelix 240/480 mg n=66 Participants Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.
Serum Levels of PSA Over Time Day 28	3.5 ng/mL Interval 0.0 to 274.6	3.1 ng/mL Interval 0.2 to 91.3
Serum Levels of PSA Over Time Day 84	1.2 ng/mL Interval 0.0 to 37.2	1.2 ng/mL Interval 0.0 to 47.4
Serum Levels of PSA Over Time Day 364	0.4 ng/mL Interval 0.0 to 354.4	0.7 ng/mL Interval 0.0 to 135.5

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	Degarelix 240/360 mg n=67 Participants Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.	Degarelix 240/480 mg n=66 Participants Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.
Serum Levels of Follicle Stimulating Hormone (FSH) Over Time Day 28	0.3 IU/L Interval 0.2 to 3.2	0.4 IU/L Interval 0.2 to 8.1
Serum Levels of Follicle Stimulating Hormone (FSH) Over Time Day 84	0.6 IU/L Interval 0.2 to 3.9	0.5 IU/L Interval 0.2 to 7.2
Serum Levels of Follicle Stimulating Hormone (FSH) Over Time Day 364	1.6 IU/L Interval 0.2 to 7.9	1.0 IU/L Interval 0.2 to 9.2

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	Degarelix 240/360 mg n=67 Participants Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.	Degarelix 240/480 mg n=66 Participants Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.
Serum Levels of Luteinizing Hormone (LH) Over Time Day 28	0.1 IU/L Interval 0.0 to 1.6	0.1 IU/L Interval 0.0 to 4.7
Serum Levels of Luteinizing Hormone (LH) Over Time Day 84	0.1 IU/L Interval 0.0 to 1.4	0.1 IU/L Interval 0.0 to 2.5
Serum Levels of Luteinizing Hormone (LH) Over Time Day 364	0.3 IU/L Interval 0.0 to 3.6	0.2 IU/L Interval 0.0 to 2.1

SECONDARY outcome

Timeframe: Baseline up to 1 year

This outcome measure included incidence of markedly abnormal values in blood pressure (systolic and diastolic), pulse, and body weight during the trial. The table presents the number of participants with a normal baseline value and at least one post-baseline markedly abnormal value.

Outcome measures

Measure	Degarelix 240/360 mg n=67 Participants Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.	Degarelix 240/480 mg n=66 Participants Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight Diastolic blood pressure <=50 and decrease >=15	0 participants	0 participants
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight Diastolic blood pressure >=105 and increase >=15	0 participants	0 participants
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight Systolic blood pressure <=90 and decrease >=20	0 participants	0 participants
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight Systolic blood pressure >=180 and increase >=20	1 participants	1 participants
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight Heart rate <=50 and decrease >=15	0 participants	0 participants
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight Heart rate >=120 and increase >=15	0 participants	0 participants
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight Body weight decrease of >=7 percent	6 participants	0 participants
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight Body weight increase of >=7 percent	8 participants	4 participants

SECONDARY outcome

Timeframe: 1 year

The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase 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.

Outcome measures

Measure	Degarelix 240/360 mg n=67 Participants Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.	Degarelix 240/480 mg n=66 Participants Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.
Liver Function Tests Abnormal alanine aminotransferase (ALAT)	22 participants	21 participants
Liver Function Tests Abnormal aspartate aminotransferase	33 participants	23 participants
Liver Function Tests Abnormal bilirubin	3 participants	1 participants
Liver Function Tests ALAT >3x upper limit of normal (ULN)	1 participants	3 participants
Liver Function Tests ALAT >3x ULN, bilirubin >1.5x ULN	0 participants	0 participants

Adverse Events

Degarelix 240/360 mg

Serious events: 7 serious events

Other events: 49 other events

Deaths: 0 deaths

Degarelix 240/480 mg

Serious events: 11 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Measure	Degarelix 240/360 mg n=67 participants at risk Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.	Degarelix 240/480 mg n=66 participants at risk Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.
Blood and lymphatic system disorders Anaemia	1.5% 1/67 • Number of events 2 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	0.00% 0/66 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.00% 0/67 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	1.5% 1/66 • Number of events 1 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Cardiac disorders Atrial fibrillation	1.5% 1/67 • Number of events 1 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	1.5% 1/66 • Number of events 1 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Cardiac disorders Atrial flutter	1.5% 1/67 • Number of events 1 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	0.00% 0/66 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Cardiac disorders Cardiac arrest	0.00% 0/67 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	1.5% 1/66 • Number of events 1 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Cardiac disorders Myocardial infarction	0.00% 0/67 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	1.5% 1/66 • Number of events 1 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Cardiac disorders Ventricular tachycardia	1.5% 1/67 • Number of events 1 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	0.00% 0/66 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Gastrointestinal disorders Inguinal hernia	0.00% 0/67 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	1.5% 1/66 • Number of events 1 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Gastrointestinal disorders Inguinal hernia strangulated	0.00% 0/67 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	1.5% 1/66 • Number of events 1 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Gastrointestinal disorders Mechanical ileus	0.00% 0/67 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	1.5% 1/66 • Number of events 1 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
General disorders Death	0.00% 0/67 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	1.5% 1/66 • Number of events 1 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Hepatobiliary disorders Bile duct obstruction	1.5% 1/67 • Number of events 1 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	0.00% 0/66 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Hepatobiliary disorders Cholecystitis	1.5% 1/67 • Number of events 1 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	0.00% 0/66 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Infections and infestations Bronchopneumonia	0.00% 0/67 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	1.5% 1/66 • Number of events 1 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Infections and infestations Lyme disease	0.00% 0/67 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	1.5% 1/66 • Number of events 1 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/67 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	1.5% 1/66 • Number of events 1 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/67 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	1.5% 1/66 • Number of events 1 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple myeloma	1.5% 1/67 • Number of events 1 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	0.00% 0/66 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Nervous system disorders Depressed level of consciousness	0.00% 0/67 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	1.5% 1/66 • Number of events 1 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Nervous system disorders Syncope	1.5% 1/67 • Number of events 1 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	0.00% 0/66 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Renal and urinary disorders Renal failure acute	0.00% 0/67 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	1.5% 1/66 • Number of events 1 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Renal and urinary disorders Tubulointerstitial nephritis	0.00% 0/67 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	1.5% 1/66 • Number of events 1 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Renal and urinary disorders Urinary retention	0.00% 0/67 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	1.5% 1/66 • Number of events 1 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Vascular disorders Deep vein thrombosis	1.5% 1/67 • Number of events 1 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	0.00% 0/66 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.

Other adverse events

Measure	Degarelix 240/360 mg n=67 participants at risk Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.	Degarelix 240/480 mg n=66 participants at risk Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.
General disorders Injection site pain	14.9% 10/67 • Number of events 19 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	19.7% 13/66 • Number of events 29 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
General disorders Injection site erythema	6.0% 4/67 • Number of events 4 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	7.6% 5/66 • Number of events 10 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
General disorders Asthenia	6.0% 4/67 • Number of events 4 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	4.5% 3/66 • Number of events 3 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
General disorders Fatigue	3.0% 2/67 • Number of events 2 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	6.1% 4/66 • Number of events 4 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
General disorders Pyrexia	0.00% 0/67 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	7.6% 5/66 • Number of events 5 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Investigations Weight increased	13.4% 9/67 • Number of events 9 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	7.6% 5/66 • Number of events 5 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Investigations Weight decreased	6.0% 4/67 • Number of events 4 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	3.0% 2/66 • Number of events 2 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Musculoskeletal and connective tissue disorders Arthralgia	6.0% 4/67 • Number of events 4 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	3.0% 2/66 • Number of events 2 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Reproductive system and breast disorders Testicular atrophy	6.0% 4/67 • Number of events 4 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	6.1% 4/66 • Number of events 5 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Reproductive system and breast disorders Gynaecomastia	6.0% 4/67 • Number of events 4 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	3.0% 2/66 • Number of events 2 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Vascular disorders Hot flush	35.8% 24/67 • Number of events 25 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	31.8% 21/66 • Number of events 23 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Vascular disorders Hypertension	9.0% 6/67 • Number of events 6 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	7.6% 5/66 • Number of events 5 • 1 year. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.

Additional Information

Ferring Pharmaceuticals

Clinical Development Support

Email: DK0-Disclosure@ferring.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER