Trial Outcomes & Findings for A Trial of Degarelix in Men With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) (NCT NCT00947882)

Last Updated: 2015-06-08

Results Overview

This outcome measure was used to assess the dose-response of the 3 degarelix dose groups in terms of severity of lower urinary tract symptoms (LUTS) and progress of the disease process, versus the placebo group. One treatment month equals 28 days. The IPSS questionnaire is a tool commonly used to assess the severity of LUTS, and to monitor the progress of the symptoms during treatment. It contains 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5 (i.e. minimum total score is 0 and the maximum score is 35), where "0" corresponds to a response of "not at all" for the first six symptoms and "none" for nocturia, and "5" corresponds to a response of "almost always" for the first six symptoms and "5 times or more" for nocturia. The IPSS also includes a question to evaluate a patient's quality of life in relation to his urinary symptoms, which is not included in the total IPSS score.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

404 participants

Primary outcome timeframe

From Baseline to Month 3 after Dosing

Results posted on

2015-06-08

Participant Flow

Patients who met the eligibility criteria were randomised in a 1:1:1:1 manner to 1 of the 4 treatment groups in this trial. The randomisation was stratified by region (North America and Europe) and prostate volume (\<30 mL and ≥30 mL). 404 patients were randomised and received a single dose of placebo, 10 mg, 20 mg, or 30 mg degarelix.

Participant milestones

Participant milestones
Measure	Placebo Placebo: Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.	Degarelix 10 mg Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.	Degarelix 20 mg Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.	Degarelix 30 mg Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
Overall Study STARTED	100	101	101	102
Overall Study Full Analysis Set (FAS)	100	101	100	102
Overall Study Actual Treatment	98	101	100	105
Overall Study Safety Analysis Set	98	101	100	105
Overall Study Visit 12, Month 6	93	91	90	95
Overall Study COMPLETED	26	24	22	20
Overall Study NOT COMPLETED	74	77	79	82

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo: Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.	Degarelix 10 mg Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.	Degarelix 20 mg Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.	Degarelix 30 mg Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
Overall Study Adverse Event	0	1	4	4
Overall Study Withdrawal by Subject	2	0	8	2
Overall Study Protocol Violation	0	0	1	0
Overall Study Lost to Follow-up	0	2	1	0
Overall Study Other/Unknown	10	13	3	6
Overall Study Trial Terminated by Sponsor	62	61	62	70

Baseline Characteristics

A Trial of Degarelix in Men With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=100 Participants Placebo: Mannitol 50 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.	Degarelix 10 mg n=101 Participants Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.	Degarelix 20 mg n=100 Participants Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.	Degarelix 30 mg n=102 Participants Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.	Total n=403 Participants Total of all reporting groups
Age, Continuous	65.2 years STANDARD_DEVIATION 7.86 • n=5 Participants	64.9 years STANDARD_DEVIATION 7.89 • n=7 Participants	65.7 years STANDARD_DEVIATION 7.12 • n=5 Participants	65.4 years STANDARD_DEVIATION 7.56 • n=4 Participants	65.3 years STANDARD_DEVIATION 7.59 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Male	100 Participants n=5 Participants	101 Participants n=7 Participants	100 Participants n=5 Participants	102 Participants n=4 Participants	403 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	9 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	99 Participants n=5 Participants	97 Participants n=7 Participants	100 Participants n=5 Participants	98 Participants n=4 Participants	394 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 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	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	13 Participants n=21 Participants
Race (NIH/OMB) White	96 Participants n=5 Participants	96 Participants n=7 Participants	96 Participants n=5 Participants	96 Participants n=4 Participants	384 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment North America	59 participants n=5 Participants	60 participants n=7 Participants	61 participants n=5 Participants	60 participants n=4 Participants	240 participants n=21 Participants
Region of Enrollment Europe	41 participants n=5 Participants	41 participants n=7 Participants	39 participants n=5 Participants	42 participants n=4 Participants	163 participants n=21 Participants
Baseline Body Mass Index (BMI)	28.5 (kg/m^2) STANDARD_DEVIATION 3.66 • n=5 Participants	28.4 (kg/m^2) STANDARD_DEVIATION 3.93 • n=7 Participants	27.9 (kg/m^2) STANDARD_DEVIATION 3.84 • n=5 Participants	28.2 (kg/m^2) STANDARD_DEVIATION 4.81 • n=4 Participants	28.2 (kg/m^2) STANDARD_DEVIATION 4.08 • n=21 Participants
Baseline International Prostate Symptom Scores (IPSS)	19.1 units on a scale STANDARD_DEVIATION 4.38 • n=5 Participants	19.9 units on a scale STANDARD_DEVIATION 5.21 • n=7 Participants	19.6 units on a scale STANDARD_DEVIATION 4.42 • n=5 Participants	19.8 units on a scale STANDARD_DEVIATION 4.88 • n=4 Participants	19.6 units on a scale STANDARD_DEVIATION 4.73 • n=21 Participants
Baseline Total Prostate Volume (TPV)	41.6 mL STANDARD_DEVIATION 17.8 • n=5 Participants	42.9 mL STANDARD_DEVIATION 18.8 • n=7 Participants	42.3 mL STANDARD_DEVIATION 20.2 • n=5 Participants	42.1 mL STANDARD_DEVIATION 20.2 • n=4 Participants	42.2 mL STANDARD_DEVIATION 19.2 • n=21 Participants
Baseline Maximum Urinary Flow (Qmax)	10.2 mL/sec STANDARD_DEVIATION 2.51 • n=5 Participants	10.3 mL/sec STANDARD_DEVIATION 2.65 • n=7 Participants	10.6 mL/sec STANDARD_DEVIATION 4.58 • n=5 Participants	10.2 mL/sec STANDARD_DEVIATION 2.44 • n=4 Participants	10.3 mL/sec STANDARD_DEVIATION 3.05 • n=21 Participants

PRIMARY outcome

Timeframe: From Baseline to Month 3 after Dosing

Population: FAS. The "as planned" patient allocation for treatment groups was used in the efficacy analyses (please refer to the Baseline Characteristics section).

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.	Degarelix 10 mg n=101 Participants Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.	Degarelix 20 mg n=100 Participants Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.	Degarelix 30 mg n=102 Participants Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
Mean Change in International Prostate Symptom Score (IPSS)	-4.46 percentage change from baseline Standard Deviation 5.34	-5.65 percentage change from baseline Standard Deviation 6.03	-6.11 percentage change from baseline Standard Deviation 5.7	-5.88 percentage change from baseline Standard Deviation 5.97

SECONDARY outcome

Timeframe: From Baseline to Month 4, Month 5 and Month 6 after Dosing

Population: FAS. The "as planned" patient allocation for treatment groups was used (please refer to the Baseline Characteristics section).

This secondary outcome measure was used to assess the maintained dose-response of the 3 degarelix dose groups in terms of severity of LUTS and progress of the disease process, versus the placebo group.

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.	Degarelix 10 mg n=101 Participants Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.	Degarelix 20 mg n=100 Participants Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.	Degarelix 30 mg n=102 Participants Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
Mean Change in IPSS Mean Percentage Change at Month 5	-4.34 percentage change from baseline Standard Deviation 5.94	-5.59 percentage change from baseline Standard Deviation 6.89	-6.1 percentage change from baseline Standard Deviation 6.46	-5.37 percentage change from baseline Standard Deviation 5.97
Mean Change in IPSS Mean Percentage Change at Month 4	-4.12 percentage change from baseline Standard Deviation 5.65	-5.52 percentage change from baseline Standard Deviation 6.18	-6.3 percentage change from baseline Standard Deviation 6.38	-5.64 percentage change from baseline Standard Deviation 5.6
Mean Change in IPSS Mean Percentage Change at Month 6	-4.3 percentage change from baseline Standard Deviation 5.47	-5.42 percentage change from baseline Standard Deviation 6.7	-5.72 percentage change from baseline Standard Deviation 5.59	-5.62 percentage change from baseline Standard Deviation 5.69

SECONDARY outcome

Timeframe: At Month 3, Month 4, Month 5 and Month 6 after Dosing

Population: FAS. The "as planned" patient allocation for treatment groups was used (please refer to the Baseline Characteristics section).

A 3-point reduction in IPSS score compared to baseline is defined as a clinically meaningful treatment response. Percentage of participants who met criteria for a clinically meaningful treatment response and odds ratios of treatment responses between each degarelix dose group and the placebo group are presented.

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.	Degarelix 10 mg n=101 Participants Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.	Degarelix 20 mg n=100 Participants Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.	Degarelix 30 mg n=102 Participants Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS 3-point reduction in IPSS vs. baseline (Month 3)	59.0 percentage of participants	72.3 percentage of participants	69.0 percentage of participants	68.6 percentage of participants
Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS 3-point reduction in IPSS vs. baseline (Month 4)	57.0 percentage of participants	65.3 percentage of participants	71.0 percentage of participants	70.6 percentage of participants
Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS 3-point reduction in IPSS vs. baseline (Month 5)	61.0 percentage of participants	64.4 percentage of participants	66.0 percentage of participants	67.6 percentage of participants
Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS 3-point reduction in IPSS vs. baseline (Month 6)	62.0 percentage of participants	68.3 percentage of participants	67.0 percentage of participants	71.6 percentage of participants

SECONDARY outcome

Timeframe: From Baseline to Month 3 and Month 6 after Dosing

Population: FAS. The "as planned" patient allocation for treatment groups was used (please refer to the Baseline Characteristics section).

TPV was measured directly by standardised trans-rectal ultrasound (TRUS).

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.	Degarelix 10 mg n=101 Participants Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.	Degarelix 20 mg n=100 Participants Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.	Degarelix 30 mg n=102 Participants Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
Mean Percentage Change in Total Prostate Volume (TPV) Mean Percentage Change at Month 3	3.15 percentage change from baseline Standard Deviation 23.3	-1.46 percentage change from baseline Standard Deviation 32.7	-0.252 percentage change from baseline Standard Deviation 24.5	0.188 percentage change from baseline Standard Deviation 24.4
Mean Percentage Change in Total Prostate Volume (TPV) Mean Percentage Change at Month 6	3.96 percentage change from baseline Standard Deviation 29.3	1.57 percentage change from baseline Standard Deviation 31	2.35 percentage change from baseline Standard Deviation 26.5	-0.0112 percentage change from baseline Standard Deviation 20.9

SECONDARY outcome

Timeframe: From Baseline to Month 3 and Month 6 after Dosing

Population: FAS. The "as planned" patient allocation for treatment groups was used (please refer to the Baseline Characteristics section).

Urinary flow rate (mL/second) was measured using uroflowmetry performed according to the recommendation from the International Continence Society (ICS).

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.	Degarelix 10 mg n=101 Participants Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.	Degarelix 20 mg n=100 Participants Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.	Degarelix 30 mg n=102 Participants Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
Mean Change in Maximum Urinary Flow (Qmax) Mean Percentage Change at Month 3	0.652 percentage change from baseline Standard Deviation 3.8	0.564 percentage change from baseline Standard Deviation 5.08	0.626 percentage change from baseline Standard Deviation 5.68	0.723 percentage change from baseline Standard Deviation 3.91
Mean Change in Maximum Urinary Flow (Qmax) Mean Percentage Change at Month 6	1.04 percentage change from baseline Standard Deviation 5.34	0.516 percentage change from baseline Standard Deviation 4.85	0.582 percentage change from baseline Standard Deviation 5.43	1.43 percentage change from baseline Standard Deviation 5.29

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 31 other events

Deaths: 0 deaths

Degarelix 10 mg

Serious events: 8 serious events

Other events: 35 other events

Deaths: 0 deaths

Degarelix 20 mg

Serious events: 2 serious events

Other events: 39 other events

Deaths: 0 deaths

Degarelix 30 mg

Serious events: 7 serious events

Other events: 56 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=98 participants at risk Placebo: Mannitol 50 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.	Degarelix 10 mg n=101 participants at risk Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.	Degarelix 20 mg n=100 participants at risk Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.	Degarelix 30 mg n=105 participants at risk Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
General disorders Injection site erythema	0.00% 0/98 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	10.9% 11/101 • Number of events 11 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	14.0% 14/100 • Number of events 14 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	17.1% 18/105 • Number of events 18 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.
General disorders Injection site pain	0.00% 0/98 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	2.0% 2/101 • Number of events 2 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	10.0% 10/100 • Number of events 10 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	17.1% 18/105 • Number of events 19 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.
General disorders Injection site induration	0.00% 0/98 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	5.9% 6/101 • Number of events 6 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	7.0% 7/100 • Number of events 7 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	10.5% 11/105 • Number of events 11 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.
Vascular disorders Hypertension	7.1% 7/98 • Number of events 8 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	5.9% 6/101 • Number of events 6 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	4.0% 4/100 • Number of events 5 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	8.6% 9/105 • Number of events 10 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.
Musculoskeletal and connective tissue disorders Back pain	9.2% 9/98 • Number of events 9 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	5.0% 5/101 • Number of events 5 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	5.0% 5/100 • Number of events 5 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	4.8% 5/105 • Number of events 6 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.
Investigations Prostatic specific antigen increased	6.1% 6/98 • Number of events 6 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	4.0% 4/101 • Number of events 4 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	5.0% 5/100 • Number of events 6 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	5.7% 6/105 • Number of events 6 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.
Infections and infestations Nasopharyngitis	5.1% 5/98 • Number of events 5 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	6.9% 7/101 • Number of events 8 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	2.0% 2/100 • Number of events 2 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	4.8% 5/105 • Number of events 5 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.
Vascular disorders Hot flush	1.0% 1/98 • Number of events 2 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	0.99% 1/101 • Number of events 1 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	4.0% 4/100 • Number of events 4 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	7.6% 8/105 • Number of events 10 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.
Infections and infestations Influenza	5.1% 5/98 • Number of events 5 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	5.0% 5/101 • Number of events 5 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	3.0% 3/100 • Number of events 3 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	4.8% 5/105 • Number of events 5 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.
Nervous system disorders Headache	5.1% 5/98 • Number of events 5 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	3.0% 3/101 • Number of events 3 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	3.0% 3/100 • Number of events 3 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	2.9% 3/105 • Number of events 3 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Cough	5.1% 5/98 • Number of events 5 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	3.0% 3/101 • Number of events 3 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	1.0% 1/100 • Number of events 1 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.	1.9% 2/105 • Number of events 2 • This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing. Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.

Additional Information

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Ferring Pharmaceuticals

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