Trial Outcomes & Findings for A Comparative Study of Degarelix Three-month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer (NCT NCT00116753)

Last Updated: 2010-12-10

Results Overview

Figure in the table give the number of participants with all testosterone values \<=0.5 ng/mL from Day 28 to the end of the study.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

460 participants

Primary outcome timeframe

From Day 28 to 12 or 13 months

Results posted on

2010-12-10

Participant Flow

Participant milestones

Participant milestones
Measure	Degarelix 240@40/240@40 (1,3,6,9) 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.	Degarelix 240@40/240@60 (1,3,6,9) 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.	Degarelix 240@40/240@60 (1,4,7,10) 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
Overall Study STARTED	153	155	152
Overall Study ITT Population	150	150	147
Overall Study COMPLETED	121	125	128
Overall Study NOT COMPLETED	32	30	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Degarelix 240@40/240@40 (1,3,6,9) 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.	Degarelix 240@40/240@60 (1,3,6,9) 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.	Degarelix 240@40/240@60 (1,4,7,10) 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
Overall Study Adverse Event	16	10	7
Overall Study Withdrawal by Subject	11	12	8
Overall Study Lost to Follow-up	0	2	1
Overall Study Protocol Violation	0	0	1
Overall Study Did not Fulfil Eligibility Criteria	1	1	3
Overall Study Disease Progression	3	4	3
Overall Study Abnormal Echocardiogram	0	0	1
Overall Study Progressive Parkinson's Disease	1	0	0
Overall Study Dosing Error	0	1	0

Baseline Characteristics

A Comparative Study of Degarelix Three-month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Degarelix 240@40/240@40 (1,3,6,9) n=150 Participants 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.	Degarelix 240@40/240@60 (1,3,6,9) n=150 Participants 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.	Degarelix 240@40/240@60 (1,4,7,10) n=147 Participants 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.	Total n=447 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	19 Participants n=7 Participants	20 Participants n=5 Participants	60 Participants n=4 Participants
Age, Categorical >=65 years	129 Participants n=5 Participants	131 Participants n=7 Participants	127 Participants n=5 Participants	387 Participants n=4 Participants
Age Continuous	75 years n=5 Participants	75 years n=7 Participants	75 years n=5 Participants	75 years n=4 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
Sex: Female, Male Male	150 Participants n=5 Participants	150 Participants n=7 Participants	147 Participants n=5 Participants	447 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	15 Participants n=7 Participants	8 Participants n=5 Participants	32 Participants n=4 Participants
Race (NIH/OMB) White	141 Participants n=5 Participants	131 Participants n=7 Participants	136 Participants n=5 Participants	408 Participants n=4 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
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
Curative Intent Yes	17 Participants n=5 Participants	22 Participants n=7 Participants	17 Participants n=5 Participants	56 Participants n=4 Participants
Curative Intent No	133 Participants n=5 Participants	128 Participants n=7 Participants	130 Participants n=5 Participants	391 Participants n=4 Participants
Gleason Score 2-4	16 participants n=5 Participants	9 participants n=7 Participants	15 participants n=5 Participants	40 participants n=4 Participants
Gleason Score 5-6	52 participants n=5 Participants	43 participants n=7 Participants	61 participants n=5 Participants	156 participants n=4 Participants
Gleason Score 7-10	82 participants n=5 Participants	97 participants n=7 Participants	70 participants n=5 Participants	249 participants n=4 Participants
Stage of Prostate Cancer Localized	56 participants n=5 Participants	62 participants n=7 Participants	66 participants n=5 Participants	184 participants n=4 Participants
Stage of Prostate Cancer Locally advanced	40 participants n=5 Participants	31 participants n=7 Participants	34 participants n=5 Participants	105 participants n=4 Participants
Stage of Prostate Cancer Metastatic	28 participants n=5 Participants	30 participants n=7 Participants	26 participants n=5 Participants	84 participants n=4 Participants
Stage of Prostate Cancer Not classifiable	26 participants n=5 Participants	27 participants n=7 Participants	21 participants n=5 Participants	74 participants n=4 Participants
Time Since Prostate Cancer Diagnosis	465 days STANDARD_DEVIATION 1041 • n=5 Participants	388 days STANDARD_DEVIATION 968 • n=7 Participants	346 days STANDARD_DEVIATION 738 • n=5 Participants	400 days STANDARD_DEVIATION 925 • n=4 Participants
Body Weight	78.5 kilogram STANDARD_DEVIATION 14.6 • n=5 Participants	78.4 kilogram STANDARD_DEVIATION 13.9 • n=7 Participants	77.4 kilogram STANDARD_DEVIATION 12.9 • n=5 Participants	78.1 kilogram STANDARD_DEVIATION 13.8 • n=4 Participants
Body Mass Index	25.9 kilogram per square meter STANDARD_DEVIATION 4.25 • n=5 Participants	26.3 kilogram per square meter STANDARD_DEVIATION 4.42 • n=7 Participants	26.0 kilogram per square meter STANDARD_DEVIATION 4.24 • n=5 Participants	26.0 kilogram per square meter STANDARD_DEVIATION 4.30 • n=4 Participants
Serum Testosterone Levels	4.43 nanogram per milliliter n=5 Participants	4.00 nanogram per milliliter n=7 Participants	4.07 nanogram per milliliter n=5 Participants	4.23 nanogram per milliliter n=4 Participants
Serum Prostate Specific Antigen Levels	13.8 nanogram per milliliter n=5 Participants	16.6 nanogram per milliliter n=7 Participants	15.6 nanogram per milliliter n=5 Participants	15.6 nanogram per milliliter n=4 Participants

PRIMARY outcome

Timeframe: From Day 28 to 12 or 13 months

Population: Observed Cases in ITT population.

Figure in the table give the number of participants with all testosterone values \<=0.5 ng/mL from Day 28 to the end of the study.

Outcome measures

Outcome measures
Measure	Degarelix 240@40/240@40 (1,3,6,9) n=120 Participants 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.	Degarelix 240@40/240@60 (1,3,6,9) n=127 Participants 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.	Degarelix 240@40/240@60 (1,4,7,10) n=129 Participants 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
Number of Participants With Testosterone Level <=0.5 ng/mL From Day 28 Until the End of the Study	94 participants Interval 69.0 to 86.0	101 participants Interval 71.0 to 87.0	110 participants Interval 77.0 to 91.0

SECONDARY outcome

Timeframe: From after Day 28 to 12 or 13 months

Population: Observed Cases in ITT population.

Figures in the table give the number of participants with all testosterone values \<=0.5 ng/mL after the dose at Day 28 to end of study. Thus, the testosterone response after the initial dose is not included in this outcome measure.

Outcome measures

Outcome measures
Measure	Degarelix 240@40/240@40 (1,3,6,9) n=119 Participants 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.	Degarelix 240@40/240@60 (1,3,6,9) n=126 Participants 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.	Degarelix 240@40/240@60 (1,4,7,10) n=129 Participants 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
Number of Participants With Testosterone Level <=0.5 ng/mL After the Dose at Day 28 Until the End of the Study	96 participants Interval 72.0 to 88.0	101 participants Interval 72.0 to 87.0	111 participants Interval 78.0 to 92.0

SECONDARY outcome

Timeframe: 28 Days

Population: Observed Cases in ITT population.

Figures in the table give number of participants with testosterone \<=0.5 ng/mL 28 days after the initial dose of trial medication.

Outcome measures

Outcome measures
Measure	Degarelix 240@40/240@40 (1,3,6,9) n=146 Participants 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.	Degarelix 240@40/240@60 (1,3,6,9) n=146 Participants 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.	Degarelix 240@40/240@60 (1,4,7,10) n=145 Participants 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
Number of Participants With Testosterone <=0.5 ng/mL at Day 28	142 participants Interval 93.0 to 99.0	143 participants Interval 94.0 to 100.0	142 participants Interval 94.0 to 100.0

SECONDARY outcome

Timeframe: 12 or 13 months

Population: ITT population.

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

Outcome measures
Measure	Degarelix 240@40/240@40 (1,3,6,9) n=150 Participants 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.	Degarelix 240@40/240@60 (1,3,6,9) n=150 Participants 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.	Degarelix 240@40/240@60 (1,4,7,10) n=147 Participants 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
Liver Function Tests ALAT >3x ULN, bilirubin 1.5x ULN	0 participants	0 participants	0 participants
Liver Function Tests Abnormal alanine aminotransferase (ALAT)	60 participants	56 participants	57 participants
Liver Function Tests Abnormal aspartate aminitransferase	40 participants	45 participants	50 participants
Liver Function Tests Abnormal bilirubin	4 participants	7 participants	2 participants
Liver Function Tests ALAT >3x upper limit of normal (ULN)	2 participants	2 participants	6 participants

SECONDARY outcome

Timeframe: 12 or 13 months

Population: ITT population.

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@40/240@40 (1,3,6,9) n=150 Participants 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.	Degarelix 240@40/240@60 (1,3,6,9) n=150 Participants 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.	Degarelix 240@40/240@60 (1,4,7,10) n=147 Participants 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
Number of Participants With Markedly Abnormal Change in Vital Signs and Body Weight as Compared to Baseline Diastolic blood pressure <=50 and decrease >=15	4 participants	6 participants	2 participants
Number of Participants With Markedly Abnormal Change in Vital Signs and Body Weight as Compared to Baseline Diastolic blood pressure >=105 and increase >=15	5 participants	7 participants	7 participants
Number of Participants With Markedly Abnormal Change in Vital Signs and Body Weight as Compared to Baseline Systolic blood pressure <=90 and decrease >=20	1 participants	3 participants	3 participants
Number of Participants With Markedly Abnormal Change in Vital Signs and Body Weight as Compared to Baseline Systolic blood pressure >=180 and increase >=20	5 participants	10 participants	12 participants
Number of Participants With Markedly Abnormal Change in Vital Signs and Body Weight as Compared to Baseline Heart rate <=50 and decrease >=15	6 participants	7 participants	8 participants
Number of Participants With Markedly Abnormal Change in Vital Signs and Body Weight as Compared to Baseline Heart rate >=120 and increase >=15	1 participants	2 participants	0 participants
Number of Participants With Markedly Abnormal Change in Vital Signs and Body Weight as Compared to Baseline Body weight decrease of >=7 percent	5 participants	4 participants	0 participants
Number of Participants With Markedly Abnormal Change in Vital Signs and Body Weight as Compared to Baseline Body weight increase of >=7 percent	21 participants	19 participants	17 participants

Adverse Events

Degarelix 240@40/240@40 (1,3,6,9)

Serious events: 28 serious events

Other events: 117 other events

Deaths: 0 deaths

Degarelix 240@40/240@60 (1,3,6,9)

Serious events: 25 serious events

Other events: 110 other events

Deaths: 0 deaths

Degarelix 240@40/240@60 (1,4,7,10)

Serious events: 19 serious events

Other events: 107 other events

Deaths: 0 deaths

Serious adverse events

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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Degarelix 240@40/240@40 (1,3,6,9) n=150 participants at risk 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.	Degarelix 240@40/240@60 (1,3,6,9) n=150 participants at risk 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.	Degarelix 240@40/240@60 (1,4,7,10) n=147 participants at risk 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
Blood and lymphatic system disorders Anaemia	4.7% 7/150 • Number of events 8 • 12 or 13 months. 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.	2.0% 3/150 • Number of events 3 • 12 or 13 months. 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.	4.1% 6/147 • Number of events 6 • 12 or 13 months. 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	5.3% 8/150 • Number of events 8 • 12 or 13 months. 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.	6.7% 10/150 • Number of events 10 • 12 or 13 months. 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.	3.4% 5/147 • Number of events 9 • 12 or 13 months. 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	30.0% 45/150 • Number of events 85 • 12 or 13 months. 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.	20.7% 31/150 • Number of events 68 • 12 or 13 months. 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.	21.1% 31/147 • Number of events 53 • 12 or 13 months. 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	20.7% 31/150 • Number of events 50 • 12 or 13 months. 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.	10.0% 15/150 • Number of events 29 • 12 or 13 months. 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.	11.6% 17/147 • Number of events 25 • 12 or 13 months. 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	9.3% 14/150 • Number of events 17 • 12 or 13 months. 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.	7.3% 11/150 • Number of events 12 • 12 or 13 months. 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.	7.5% 11/147 • Number of events 12 • 12 or 13 months. 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 nodule	6.7% 10/150 • Number of events 16 • 12 or 13 months. 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.	3.3% 5/150 • Number of events 11 • 12 or 13 months. 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.	7.5% 11/147 • Number of events 22 • 12 or 13 months. 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 swelling	3.3% 5/150 • Number of events 10 • 12 or 13 months. 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.	8.7% 13/150 • Number of events 24 • 12 or 13 months. 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.	2.7% 4/147 • Number of events 6 • 12 or 13 months. 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	8.0% 12/150 • Number of events 18 • 12 or 13 months. 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.	2.0% 3/150 • Number of events 8 • 12 or 13 months. 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.	4.1% 6/147 • Number of events 7 • 12 or 13 months. 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 induration	4.7% 7/150 • Number of events 8 • 12 or 13 months. 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.	2.7% 4/150 • Number of events 5 • 12 or 13 months. 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% 9/147 • Number of events 14 • 12 or 13 months. 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	7.3% 11/150 • Number of events 17 • 12 or 13 months. 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.	6.0% 9/150 • Number of events 11 • 12 or 13 months. 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% 9/147 • Number of events 11 • 12 or 13 months. 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 Nasopharyngitis	6.0% 9/150 • Number of events 12 • 12 or 13 months. 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.	7.3% 11/150 • Number of events 15 • 12 or 13 months. 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.	2.7% 4/147 • Number of events 4 • 12 or 13 months. 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	7.3% 11/150 • Number of events 11 • 12 or 13 months. 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.	6.0% 9/150 • Number of events 10 • 12 or 13 months. 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.	2.0% 3/147 • Number of events 3 • 12 or 13 months. 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 Alanine aminotransferase increased	3.3% 5/150 • Number of events 5 • 12 or 13 months. 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.	4.0% 6/150 • Number of events 7 • 12 or 13 months. 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.	5.4% 8/147 • Number of events 9 • 12 or 13 months. 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	8.0% 12/150 • Number of events 13 • 12 or 13 months. 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.	4.0% 6/150 • Number of events 6 • 12 or 13 months. 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.	4.1% 6/147 • Number of events 9 • 12 or 13 months. 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 Back pain	4.7% 7/150 • Number of events 8 • 12 or 13 months. 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.	5.3% 8/150 • Number of events 10 • 12 or 13 months. 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.	4.8% 7/147 • Number of events 10 • 12 or 13 months. 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 Dizziness	6.7% 10/150 • Number of events 12 • 12 or 13 months. 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.	8.0% 12/150 • Number of events 14 • 12 or 13 months. 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.	2.7% 4/147 • Number of events 4 • 12 or 13 months. 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.
Psychiatric disorders Insomnia	2.7% 4/150 • Number of events 5 • 12 or 13 months. 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.	7.3% 11/150 • Number of events 11 • 12 or 13 months. 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% 0/147 • 12 or 13 months. 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 Pollakiuria	4.7% 7/150 • Number of events 7 • 12 or 13 months. 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.	2.0% 3/150 • Number of events 3 • 12 or 13 months. 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.	1.4% 2/147 • Number of events 2 • 12 or 13 months. 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	38.0% 57/150 • Number of events 60 • 12 or 13 months. 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.	34.7% 52/150 • Number of events 59 • 12 or 13 months. 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.	35.4% 52/147 • Number of events 57 • 12 or 13 months. 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	2.7% 4/150 • Number of events 5 • 12 or 13 months. 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.	4.7% 7/150 • Number of events 7 • 12 or 13 months. 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.	2.0% 3/147 • Number of events 3 • 12 or 13 months. 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.