Trial Outcomes & Findings for Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer (NCT NCT00831233)

Last Updated: 2013-11-11

Results Overview

The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

42 participants

Primary outcome timeframe

After treatment of 12 weeks compared to Baseline

Results posted on

2013-11-11

Participant Flow

The participants were recruited by outpatient urologists. 280 participants were to be randomised in a 3:1 ratio to one of two treatment groups (210 patients were to be treated with degarelix; 70 patients were to be treated with goserelin plus bicalutamide). The trial was stopped early due to poor recruitment.

Participant milestones

Participant milestones
Measure	Degarelix 240 mg/80 mg Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)	Goserelin (3.6 mg) + Bicalutamide (50 mg) Goserelin (3.6 mg) + bicalutamide (50 mg)
Overall Study STARTED	29	13
Overall Study Full Analysis Set (FAS)	27	13
Overall Study Per Protocol (PP) Analysis Set	26	11
Overall Study COMPLETED	26	12
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Degarelix 240 mg/80 mg Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)	Goserelin (3.6 mg) + Bicalutamide (50 mg) Goserelin (3.6 mg) + bicalutamide (50 mg)
Overall Study Adverse Event	0	1
Overall Study Protocol Violation	1	0
Overall Study Selection Criteria Not Met	2	0

Baseline Characteristics

Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Degarelix 240 mg/80 mg n=27 Participants Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)	Goserelin (3.6 mg) + Bicalutamide (50 mg) n=13 Participants Goserelin (3.6 mg) + bicalutamide (50 mg)	Total n=40 Participants Total of all reporting groups
Age Continuous	69.9 years STANDARD_DEVIATION 8.68 • n=5 Participants	71.0 years STANDARD_DEVIATION 8.39 • n=7 Participants	70.3 years STANDARD_DEVIATION 8.49 • 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	27 Participants n=5 Participants	13 Participants n=7 Participants	40 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	12 Participants n=7 Participants	39 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
Region of Enrollment Spain	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment Germany	13 participants n=5 Participants	7 participants n=7 Participants	20 participants n=5 Participants
Region of Enrollment United Kingdom	10 participants n=5 Participants	2 participants n=7 Participants	12 participants n=5 Participants
Body weight	81.4 kilogram STANDARD_DEVIATION 14.0 • n=5 Participants	78.2 kilogram STANDARD_DEVIATION 8.5 • n=7 Participants	80.3 kilogram STANDARD_DEVIATION 12.5 • n=5 Participants
Body mass index	26.7 kilogram per square meter STANDARD_DEVIATION 4.06 • n=5 Participants	26.8 kilogram per square meter STANDARD_DEVIATION 3.75 • n=7 Participants	26.7 kilogram per square meter STANDARD_DEVIATION 3.91 • n=5 Participants
Gleason Score 2-4	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Gleason Score 5-6	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Gleason Score 7-10	25 participants n=5 Participants	13 participants n=7 Participants	38 participants n=5 Participants
Stage of Prostate Cancer Localized	4 participants n=5 Participants	0 participants n=7 Participants	4 participants n=5 Participants
Stage of Prostate Cancer Locally Advanced	4 participants n=5 Participants	1 participants n=7 Participants	5 participants n=5 Participants
Stage of Prostate Cancer Metastatic	10 participants n=5 Participants	4 participants n=7 Participants	14 participants n=5 Participants
Stage of Prostate Cancer Not Classifiable	9 participants n=5 Participants	8 participants n=7 Participants	17 participants n=5 Participants

PRIMARY outcome

Timeframe: After treatment of 12 weeks compared to Baseline

Population: Full Analysis Set (FAS) + Per Protocol (PP) Analysis Set, Last Observation Carried Forward (LOCF).

Outcome measures

Outcome measures
Measure	Degarelix 240 mg/80 mg n=27 Participants Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)	Goserelin (3.6 mg) + Bicalutamide (50 mg) n=13 Participants Goserelin (3.6 mg) + bicalutamide (50 mg)
Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12	-11.2 score on scale Standard Deviation 8.29	-7.69 score on scale Standard Deviation 7.61

SECONDARY outcome

Timeframe: After treatment of 4 and 8 weeks compared to Baseline

Population: FAS, LOCF.

Outcome measures

Outcome measures
Measure	Degarelix 240 mg/80 mg n=26 Participants Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)	Goserelin (3.6 mg) + Bicalutamide (50 mg) n=13 Participants Goserelin (3.6 mg) + bicalutamide (50 mg)
Change From Baseline in Total IPSS at Weeks 4 and 8 Week 4	-7.31 score on scale Standard Deviation 5.83	-4.62 score on scale Standard Deviation 5.49
Change From Baseline in Total IPSS at Weeks 4 and 8 Week 8	-9.46 score on scale Standard Deviation 6.94	-8.08 score on scale Standard Deviation 9.00

SECONDARY outcome

Timeframe: After treatment of 4, 8 and 12 weeks compared to Baseline

Population: FAS, LOCF.

Uroflowmetry was used to quantify the maximum urine flow (Qmax; mL/sec)

Outcome measures

Outcome measures
Measure	Degarelix 240 mg/80 mg n=27 Participants Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)	Goserelin (3.6 mg) + Bicalutamide (50 mg) n=13 Participants Goserelin (3.6 mg) + bicalutamide (50 mg)
Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit Week 4	3.63 mL/sec Standard Deviation 7.82	3.55 mL/sec Standard Deviation 3.80
Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit Week 8	4.74 mL/sec Standard Deviation 6.60	3.52 mL/sec Standard Deviation 3.58
Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit Week 12	3.62 mL/sec Standard Deviation 7.37	2.07 mL/sec Standard Deviation 4.57

SECONDARY outcome

Timeframe: After treatment of 4, 8 and 12 weeks compared to Baseline

Population: FAS, LOCF.

Uroflowmetry was used to quantify the residual volume (Vresidual; mL)

Outcome measures

Outcome measures
Measure	Degarelix 240 mg/80 mg n=27 Participants Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)	Goserelin (3.6 mg) + Bicalutamide (50 mg) n=13 Participants Goserelin (3.6 mg) + bicalutamide (50 mg)
Change From Baseline in Residual Volume (Vresidual) at Each Visit Week 4	-36.2 mL Standard Deviation 148	-19.8 mL Standard Deviation 63.5
Change From Baseline in Residual Volume (Vresidual) at Each Visit Week 8	-43.8 mL Standard Deviation 133	-19.6 mL Standard Deviation 85.4
Change From Baseline in Residual Volume (Vresidual) at Each Visit Week 12	-50.7 mL Standard Deviation 135	-13.4 mL Standard Deviation 85.8

SECONDARY outcome

Timeframe: After 12 weeks treatment compared to Baseline

Population: FAS, Observed Cases (OC).

TRUS is a method of measuring the size of the prostate.

Outcome measures

Outcome measures
Measure	Degarelix 240 mg/80 mg n=26 Participants Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)	Goserelin (3.6 mg) + Bicalutamide (50 mg) n=11 Participants Goserelin (3.6 mg) + bicalutamide (50 mg)
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12	-22.4 mL Standard Deviation 14.8	-13.4 mL Standard Deviation 10.0

SECONDARY outcome

Timeframe: After treatment of 4, 8 and 12 weeks compared to Baseline

Population: FAS, OC.

Outcome measures

Outcome measures
Measure	Degarelix 240 mg/80 mg n=27 Participants Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)	Goserelin (3.6 mg) + Bicalutamide (50 mg) n=13 Participants Goserelin (3.6 mg) + bicalutamide (50 mg)
Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit Week 4	26 participants	12 participants
Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit Week 8	25 participants	12 participants
Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit Week 12	27 participants	12 participants

SECONDARY outcome

Timeframe: After treatment of 4, 8 and 12 weeks compared to Baseline

Population: FAS, LOCF.

Outcome measures

Outcome measures
Measure	Degarelix 240 mg/80 mg n=27 Participants Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)	Goserelin (3.6 mg) + Bicalutamide (50 mg) n=12 Participants Goserelin (3.6 mg) + bicalutamide (50 mg)
Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit Week 4	-85.72 percentage Interval -97.87 to 234.97	-93.44 percentage Interval -98.33 to -87.09
Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit Week 8	-89.2 percentage Interval -99.47 to -31.62	-97.26 percentage Interval -99.72 to -87.56
Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit Week 12	-93.87 percentage Interval -99.83 to -64.71	-97.78 percentage Interval -99.72 to -94.52

SECONDARY outcome

Timeframe: After treatment of 4, 8 and 12 weeks compared to Baseline

Population: FAS, OC.

The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6'). The figures in the tables present the change (ie decrease) in IPSS QoL score, i.e. the bigger the decrease the better QoL.

Outcome measures

Outcome measures
Measure	Degarelix 240 mg/80 mg n=27 Participants Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)	Goserelin (3.6 mg) + Bicalutamide (50 mg) n=13 Participants Goserelin (3.6 mg) + bicalutamide (50 mg)
Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit Week 4	-0.96 score on scale Standard Deviation 0.92	-0.54 score on scale Standard Deviation 1.51
Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit Week 12	-1.77 score on scale Standard Deviation 1.73	-0.55 score on scale Standard Deviation 1.69
Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit Week 8	-1.54 score on scale Standard Deviation 1.42	-0.73 score on scale Standard Deviation 2.20

SECONDARY outcome

Timeframe: Baseline to 12 weeks of treatment

Population: FAS. One participant in the degarelix group did not have any assessment of vital signs or body weight (the number of participants in this group is thus 26).

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

Outcome measures

Outcome measures
Measure	Degarelix 240 mg/80 mg n=26 Participants Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)	Goserelin (3.6 mg) + Bicalutamide (50 mg) n=13 Participants Goserelin (3.6 mg) + bicalutamide (50 mg)
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	0 participants	0 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	1 participants	0 participants
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight Body weight increase of >=7 percent	1 participants	0 participants

SECONDARY outcome

Timeframe: Baseline to 12 weeks of treatment

Population: FAS.

The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least on participant with one abnormal value are presented, many more variables were included in the trial.

Outcome measures

Outcome measures
Measure	Degarelix 240 mg/80 mg n=27 Participants Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)	Goserelin (3.6 mg) + Bicalutamide (50 mg) n=13 Participants Goserelin (3.6 mg) + bicalutamide (50 mg)
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables S-Urea nitrogen (mmol/L) >=10.7	1 participants	2 participants
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables B-Haematocrit (Ratio) <=0.37	5 participants	1 participants
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables B-Platelet count (10^9/L) <=75	1 participants	0 participants
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables S-Calcium (mmol/L) <=1.8	1 participants	0 participants
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables S-Potassium (mmol/L) >=5.8	0 participants	1 participants

Adverse Events

Degarelix 240 mg/80 mg

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Goserelin (3.6 mg) + Bicalutamide (50 mg)

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Degarelix 240 mg/80 mg n=27 participants at risk Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)	Goserelin (3.6 mg) + Bicalutamide (50 mg) n=13 participants at risk Goserelin (3.6 mg) + bicalutamide (50 mg)
Hepatobiliary disorders Hepatic failure	0.00% 0/27 • 12 weeks. 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.	7.7% 1/13 • Number of events 1 • 12 weeks. 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) Prostate cancer	0.00% 0/27 • 12 weeks. 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.	7.7% 1/13 • Number of events 1 • 12 weeks. 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	0.00% 0/27 • 12 weeks. 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.	7.7% 1/13 • Number of events 1 • 12 weeks. 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 Prostatic obstruction	0.00% 0/27 • 12 weeks. 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.	7.7% 1/13 • Number of events 1 • 12 weeks. 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

Additional Information

Ferring Pharmaceuticals

Clinical Development Support

Email: [email protected]

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. Additional time may be required to allow Ferring to seek patent protection of the invention.
Publication restrictions are in place

Restriction type: OTHER

Measure	Degarelix 240 mg/80 mg n=27 participants at risk Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)	Goserelin (3.6 mg) + Bicalutamide (50 mg) n=13 participants at risk Goserelin (3.6 mg) + bicalutamide (50 mg)
Blood and lymphatic system disorders Anaemia	7.4% 2/27 • Number of events 2 • 12 weeks. 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% 0/13 • 12 weeks. 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 Leukocytosis	0.00% 0/27 • 12 weeks. 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.	7.7% 1/13 • Number of events 1 • 12 weeks. 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.
Congenital, familial and genetic disorders Reproductive tract hypoplasia, male	7.4% 2/27 • Number of events 2 • 12 weeks. 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% 0/13 • 12 weeks. 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 Constipation	11.1% 3/27 • Number of events 3 • 12 weeks. 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% 0/13 • 12 weeks. 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 pain	22.2% 6/27 • Number of events 16 • 12 weeks. 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% 0/13 • 12 weeks. 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	11.1% 3/27 • Number of events 5 • 12 weeks. 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% 0/13 • 12 weeks. 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	7.4% 2/27 • Number of events 2 • 12 weeks. 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% 0/13 • 12 weeks. 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	3.7% 1/27 • Number of events 1 • 12 weeks. 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.	7.7% 1/13 • Number of events 1 • 12 weeks. 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 Hepatic failure	0.00% 0/27 • 12 weeks. 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.	7.7% 1/13 • Number of events 1 • 12 weeks. 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 Cystitis	11.1% 3/27 • Number of events 4 • 12 weeks. 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.	15.4% 2/13 • Number of events 2 • 12 weeks. 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 Urinary tract infection	3.7% 1/27 • Number of events 1 • 12 weeks. 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.	15.4% 2/13 • Number of events 2 • 12 weeks. 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	11.1% 3/27 • Number of events 3 • 12 weeks. 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% 0/13 • 12 weeks. 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	3.7% 1/27 • Number of events 1 • 12 weeks. 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.	15.4% 2/13 • Number of events 2 • 12 weeks. 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) Prostate cancer	0.00% 0/27 • 12 weeks. 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.	7.7% 1/13 • Number of events 1 • 12 weeks. 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 cyst	0.00% 0/27 • 12 weeks. 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.	7.7% 1/13 • Number of events 1 • 12 weeks. 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	0.00% 0/27 • 12 weeks. 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.	7.7% 1/13 • Number of events 1 • 12 weeks. 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% 0/27 • 12 weeks. 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.	7.7% 1/13 • Number of events 2 • 12 weeks. 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 Prostatic obstruction	0.00% 0/27 • 12 weeks. 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.	7.7% 1/13 • Number of events 1 • 12 weeks. 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	18.5% 5/27 • Number of events 5 • 12 weeks. 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.	15.4% 2/13 • Number of events 2 • 12 weeks. 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.