Trial Outcomes & Findings for The Efficacy and Safety of FE 200486 in Treatment of Patients Suffering From Prostate Cancer (NCT NCT00819247)
NCT ID: NCT00819247
Last Updated: 2023-11-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
129 participants
Primary outcome timeframe
Weeks 1,2,4,8,12,16,20,24
Results posted on
2023-11-09
Participant Flow
One hundred and fifty-nine participants were screened. One hundred and twenty-nine participants were randomised, two of these participants withdrew before receiving any treatment.
Participant milestones
| Measure |
Degarelix 80/80 + 40
Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
|
Degarelix 40/40 + 40
Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
|
Degarelix 80 + 20
Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
|
|---|---|---|---|
|
Overall Study
STARTED
|
43
|
46
|
40
|
|
Overall Study
Randomized
|
43
|
46
|
40
|
|
Overall Study
Intent-to-treat Population
|
42
|
46
|
39
|
|
Overall Study
Per Protocol Population
|
38
|
44
|
38
|
|
Overall Study
COMPLETED
|
32
|
30
|
26
|
|
Overall Study
NOT COMPLETED
|
11
|
16
|
14
|
Reasons for withdrawal
| Measure |
Degarelix 80/80 + 40
Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
|
Degarelix 40/40 + 40
Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
|
Degarelix 80 + 20
Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
5
|
3
|
|
Overall Study
Insufficient testosterone response
|
5
|
8
|
10
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
1
|
|
Overall Study
Mistakenly withdrawn
|
0
|
1
|
0
|
|
Overall Study
Bad prostate-specific antigen response
|
3
|
2
|
0
|
|
Overall Study
Other
|
1
|
0
|
0
|
Baseline Characteristics
The Efficacy and Safety of FE 200486 in Treatment of Patients Suffering From Prostate Cancer
Baseline characteristics by cohort
| Measure |
Degarelix 80/80 + 40
n=43 Participants
Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
|
Degarelix 40/40 + 40
n=46 Participants
Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
|
Degarelix 80 + 20
n=40 Participants
Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
|
Total
n=129 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
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
37 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
|
Age, Continuous
|
72.4 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
73.7 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
71.8 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
72.7 years
STANDARD_DEVIATION 7.0 • 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
|
43 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
129 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
42 participants
n=5 Participants
|
43 participants
n=7 Participants
|
37 participants
n=5 Participants
|
122 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Oriental / Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Afro-carribean
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Indian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
43 participants
n=5 Participants
|
46 participants
n=7 Participants
|
40 participants
n=5 Participants
|
129 participants
n=4 Participants
|
|
Participant Counts by Gleason Score
unknown
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Participant Counts by Gleason Score
2-4
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Participant Counts by Gleason Score
5-6
|
11 participants
n=5 Participants
|
7 participants
n=7 Participants
|
11 participants
n=5 Participants
|
29 participants
n=4 Participants
|
|
Participant Counts by Gleason Score
7-10
|
28 participants
n=5 Participants
|
34 participants
n=7 Participants
|
26 participants
n=5 Participants
|
88 participants
n=4 Participants
|
|
Stage of Prostate Cancer
Localized
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
5 participants
n=5 Participants
|
22 participants
n=4 Participants
|
|
Stage of Prostate Cancer
Locally advanced
|
21 participants
n=5 Participants
|
21 participants
n=7 Participants
|
18 participants
n=5 Participants
|
60 participants
n=4 Participants
|
|
Stage of Prostate Cancer
Metastatic
|
11 participants
n=5 Participants
|
14 participants
n=7 Participants
|
17 participants
n=5 Participants
|
42 participants
n=4 Participants
|
|
Stage of Prostate Cancer
Not classifiable
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Body Mass Index
|
26.2 kilogram per square meter
n=5 Participants
|
26.6 kilogram per square meter
n=7 Participants
|
25.2 kilogram per square meter
n=5 Participants
|
26.1 kilogram per square meter
n=4 Participants
|
|
Days Since Diagnosis of Prostate Cancer
|
52.7 days
STANDARD_DEVIATION 116.0 • n=5 Participants
|
153.8 days
STANDARD_DEVIATION 518.1 • n=7 Participants
|
88.8 days
STANDARD_DEVIATION 370.0 • n=5 Participants
|
99.9 days
STANDARD_DEVIATION 377.2 • n=4 Participants
|
|
Serum Prostate-Specific Antigen level
|
50.3 nanogram/milliliter
n=5 Participants
|
64.6 nanogram/milliliter
n=7 Participants
|
82.9 nanogram/milliliter
n=5 Participants
|
61.1 nanogram/milliliter
n=4 Participants
|
|
Serum Testosterone level
|
3.7 nanogram/milliliter
n=5 Participants
|
4.1 nanogram/milliliter
n=7 Participants
|
4.8 nanogram/milliliter
n=5 Participants
|
4.0 nanogram/milliliter
n=4 Participants
|
PRIMARY outcome
Timeframe: Weeks 1,2,4,8,12,16,20,24Population: Per protocol population
Outcome measures
| Measure |
Degarelix 80/80 + 40
n=38 Participants
Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
|
Degarelix 40/40 + 40
n=44 Participants
Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
|
Degarelix 80 + 20
n=38 Participants
Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
|
|---|---|---|---|
|
Number of Participants With Testosterone <0.5 Nanogram/Milliliter
Week 1 (n=38, 44, 38)
|
38 participants
|
32 participants
|
27 participants
|
|
Number of Participants With Testosterone <0.5 Nanogram/Milliliter
Week 2 (n=38, 44, 38)
|
38 participants
|
36 participants
|
33 participants
|
|
Number of Participants With Testosterone <0.5 Nanogram/Milliliter
Week 4 (n=38, 36, 33)
|
38 participants
|
35 participants
|
31 participants
|
|
Number of Participants With Testosterone <0.5 Nanogram/Milliliter
Week 8 (n=36, 36, 31)
|
36 participants
|
36 participants
|
31 participants
|
|
Number of Participants With Testosterone <0.5 Nanogram/Milliliter
Week 12 (n=34, 34, 31)
|
34 participants
|
34 participants
|
30 participants
|
|
Number of Participants With Testosterone <0.5 Nanogram/Milliliter
Week 16 (n=34, 32, 30)
|
33 participants
|
31 participants
|
27 participants
|
|
Number of Participants With Testosterone <0.5 Nanogram/Milliliter
Week 20 (n=33, 31, 28)
|
31 participants
|
30 participants
|
25 participants
|
|
Number of Participants With Testosterone <0.5 Nanogram/Milliliter
Week 24 (n=31, 29, 25)
|
28 participants
|
27 participants
|
22 participants
|
SECONDARY outcome
Timeframe: Weeks 4-24Population: Per protocol population
Outcome measures
| Measure |
Degarelix 80/80 + 40
n=32 Participants
Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
|
Degarelix 40/40 + 40
n=29 Participants
Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
|
Degarelix 80 + 20
n=27 Participants
Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
|
|---|---|---|---|
|
Number of Participants With Testosterone < 0.5 Nanogram/Milliliter at All Visits Between Weeks 4-24
|
28 participants
|
27 participants
|
20 participants
|
SECONDARY outcome
Timeframe: Weeks 4-24Population: Per protocol population
Participants with one testoterone value \> 1.0 nanogram/millliliter or two consecutive values between 0.5-1.0 nanogram/milliliter were withdrawn from the study due to insufficient response.
Outcome measures
| Measure |
Degarelix 80/80 + 40
n=32 Participants
Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
|
Degarelix 40/40 + 40
n=29 Participants
Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
|
Degarelix 80 + 20
n=27 Participants
Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
|
|---|---|---|---|
|
Number of Participants Not Meeting a Testosterone Withdrawal Criterion Between Weeks 4-24
|
29 participants
|
29 participants
|
25 participants
|
SECONDARY outcome
Timeframe: Six monthsPopulation: per protocol population
Participants who met at least one of the three criteria for inadequate response on prostate-specific antigen levels (PA). (1) \>=25 percent and/or 50 nanogram/milliliter compared to baseline (2) reduction of \<=50% compared to baseline at week 12 (3) increase of \>=10 nanogram/milliliter compared to nadir from week 4.
Outcome measures
| Measure |
Degarelix 80/80 + 40
n=38 Participants
Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
|
Degarelix 40/40 + 40
n=44 Participants
Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
|
Degarelix 80 + 20
n=38 Participants
Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
|
|---|---|---|---|
|
Number of Participants Who Met the Withdrawl Criteria for Prostate-specific Antigen
>=25% and/or 50 ng/mL compared to baseline
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Who Met the Withdrawl Criteria for Prostate-specific Antigen
<=50% compared to baseline
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Who Met the Withdrawl Criteria for Prostate-specific Antigen
>=10 ng/mL compared to nadir
|
1 participants
|
6 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Weeks 12, 24Population: Per Protocol Population
The number of participants whose prostate-specific antigen levels at weeks 12 and 24 were \<= 4 nanogram/millliliter (normal level).
Outcome measures
| Measure |
Degarelix 80/80 + 40
n=38 Participants
Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
|
Degarelix 40/40 + 40
n=44 Participants
Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
|
Degarelix 80 + 20
n=38 Participants
Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
|
|---|---|---|---|
|
Number of Participants With Normal Prostate-specific Antigen Levels During the Study
Week 12 (n=34, 34, 31)
|
18 participants
|
18 participants
|
16 participants
|
|
Number of Participants With Normal Prostate-specific Antigen Levels During the Study
Week 24 (n=31, 29, 25)
|
18 participants
|
18 participants
|
17 participants
|
SECONDARY outcome
Timeframe: Six monthsPopulation: Randomized (Safety) population
The number of participants who had abnormal \[defined as above upper limit of normal range (ULN)\] alanine aminotransferase (ALT), participants with ALT increases \> 3x ULN, and participants with ALT increases \> 3x ULN with concurrent increases in bilirubin \> 1.5 ULN.
Outcome measures
| Measure |
Degarelix 80/80 + 40
n=43 Participants
Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
|
Degarelix 40/40 + 40
n=46 Participants
Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
|
Degarelix 80 + 20
n=40 Participants
Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
|
|---|---|---|---|
|
The Number of Participants With Abnormal Liver Function Tests
Alanine aminotransferase (ALT) above upper limit
|
13 participants
|
14 participants
|
12 participants
|
|
The Number of Participants With Abnormal Liver Function Tests
ALT levels >3x upper limit
|
0 participants
|
1 participants
|
1 participants
|
|
The Number of Participants With Abnormal Liver Function Tests
ALT levels >3x and bilirubin >1.5x upper limit
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline and Six monthsPopulation: Safety population.
Percentage changes in vital signs (systolic and diastolic blood pressure and pulse) and body weight at the end of trial as compared to baseline.
Outcome measures
| Measure |
Degarelix 80/80 + 40
n=43 Participants
Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
|
Degarelix 40/40 + 40
n=46 Participants
Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
|
Degarelix 80 + 20
n=40 Participants
Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
|
|---|---|---|---|
|
Percentage Change in Vital Signs and Body Weight
Diastolic blood pressure
|
0.0 percentage
Interval -24.0 to 43.0
|
-0.6 percentage
Interval -45.0 to 55.0
|
0.0 percentage
Interval -38.0 to 32.0
|
|
Percentage Change in Vital Signs and Body Weight
Systolic blood pressure
|
-3.7 percentage
Interval -19.0 to 23.0
|
-2.4 percentage
Interval -25.0 to 57.0
|
0.0 percentage
Interval -39.0 to 29.0
|
|
Percentage Change in Vital Signs and Body Weight
Pulse
|
-3.1 percentage
Interval -26.0 to 42.0
|
0.0 percentage
Interval -23.0 to 30.0
|
-1.5 percentage
Interval -29.0 to 44.0
|
|
Percentage Change in Vital Signs and Body Weight
Weight
|
2.8 percentage
Interval -11.0 to 24.0
|
2.6 percentage
Interval -7.0 to 17.0
|
3.5 percentage
Interval -23.0 to 17.0
|
Adverse Events
Degarelix 80/80 + 40
Serious events: 3 serious events
Other events: 38 other events
Deaths: 0 deaths
Degarelix 40/40 + 40
Serious events: 8 serious events
Other events: 38 other events
Deaths: 0 deaths
Degarelix 80 + 20
Serious events: 6 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Degarelix 80/80 + 40
Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
|
Degarelix 40/40 + 40
Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
|
Degarelix 80 + 20
Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
1/43 • Number of events 1
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Cardiac disorders
Angina pectoris
|
2.3%
1/43 • Number of events 1
|
0.00%
0/46
|
2.5%
1/40 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
2.3%
1/43 • Number of events 1
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Cardiac disorders
Cardiac failure congestive
|
2.3%
1/43 • Number of events 1
|
0.00%
0/46
|
0.00%
0/40
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/43
|
2.2%
1/46 • Number of events 2
|
0.00%
0/40
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
General disorders
Asthenia
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
General disorders
Catheter related complication
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
General disorders
Condition aggravated
|
0.00%
0/43
|
0.00%
0/46
|
2.5%
1/40 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/43
|
0.00%
0/46
|
2.5%
1/40 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Infections and infestations
Sepsis
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/43
|
0.00%
0/46
|
2.5%
1/40 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/43
|
0.00%
0/46
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Psychiatric disorders
Depression
|
2.3%
1/43 • Number of events 1
|
0.00%
0/46
|
2.5%
1/40 • Number of events 1
|
|
Psychiatric disorders
Alcoholism
|
2.3%
1/43 • Number of events 1
|
0.00%
0/46
|
0.00%
0/40
|
|
Renal and urinary disorders
Bladder obstruction
|
0.00%
0/43
|
0.00%
0/46
|
2.5%
1/40 • Number of events 1
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/43
|
0.00%
0/46
|
2.5%
1/40 • Number of events 1
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/43
|
2.2%
1/46 • Number of events 2
|
0.00%
0/40
|
Other adverse events
| Measure |
Degarelix 80/80 + 40
Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
|
Degarelix 40/40 + 40
Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
|
Degarelix 80 + 20
Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
14.0%
6/43 • Number of events 9
|
4.3%
2/46 • Number of events 2
|
5.0%
2/40 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
7.0%
3/43 • Number of events 3
|
2.2%
1/46 • Number of events 1
|
2.5%
1/40 • Number of events 1
|
|
Gastrointestinal disorders
Inguinal hernia
|
2.3%
1/43 • Number of events 1
|
2.2%
1/46 • Number of events 1
|
5.0%
2/40 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
5.0%
2/40 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/43
|
0.00%
0/46
|
5.0%
2/40 • Number of events 2
|
|
General disorders
Fatigue
|
4.7%
2/43 • Number of events 2
|
8.7%
4/46 • Number of events 5
|
0.00%
0/40
|
|
General disorders
Suprapubic pain
|
0.00%
0/43
|
0.00%
0/46
|
5.0%
2/40 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
11.6%
5/43 • Number of events 6
|
15.2%
7/46 • Number of events 7
|
12.5%
5/40 • Number of events 5
|
|
Infections and infestations
Urinary tract infection
|
7.0%
3/43 • Number of events 5
|
2.2%
1/46 • Number of events 1
|
5.0%
2/40 • Number of events 2
|
|
Investigations
Weight increased
|
0.00%
0/43
|
0.00%
0/46
|
5.0%
2/40 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.0%
3/43 • Number of events 3
|
6.5%
3/46 • Number of events 3
|
5.0%
2/40 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/43
|
6.5%
3/46 • Number of events 3
|
0.00%
0/40
|
|
Nervous system disorders
Headache
|
9.3%
4/43 • Number of events 5
|
4.3%
2/46 • Number of events 2
|
7.5%
3/40 • Number of events 4
|
|
Nervous system disorders
Lethargy
|
4.7%
2/43 • Number of events 2
|
6.5%
3/46 • Number of events 4
|
2.5%
1/40 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
7.0%
3/43 • Number of events 4
|
0.00%
0/46
|
5.0%
2/40 • Number of events 4
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
5.0%
2/40 • Number of events 2
|
|
Reproductive system and breast disorders
Testicular atrophy
|
7.0%
3/43 • Number of events 3
|
4.3%
2/46 • Number of events 2
|
10.0%
4/40 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.7%
2/43 • Number of events 2
|
4.3%
2/46 • Number of events 2
|
5.0%
2/40 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.0%
3/43 • Number of events 3
|
6.5%
3/46 • Number of events 3
|
2.5%
1/40 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
7.0%
3/43 • Number of events 3
|
0.00%
0/46
|
0.00%
0/40
|
|
Vascular disorders
Hot flush
|
48.8%
21/43 • Number of events 22
|
45.7%
21/46 • Number of events 21
|
55.0%
22/40 • Number of events 25
|
|
Vascular disorders
Flushing
|
9.3%
4/43 • Number of events 4
|
13.0%
6/46 • Number of events 6
|
5.0%
2/40 • Number of events 2
|
|
Vascular disorders
Hypertension
|
7.0%
3/43 • Number of events 3
|
4.3%
2/46 • Number of events 2
|
2.5%
1/40 • Number of events 1
|
Additional Information
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