Trial Outcomes & Findings for Explorative Study of Degarelix for Treatment of Benign Prostatic Hyperplasia. (NCT NCT00527488)
NCT ID: NCT00527488
Last Updated: 2015-05-04
Results Overview
The area of the testosterone concentration (ng/mL) vs. time (days) curve that is below the baseline interval concentration( i.e. 0.75 x baseline concentration)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
0-42 Days
Results posted on
2015-05-04
Participant Flow
Participant milestones
| Measure |
Degarelix 16+16 mg
Two doses of Degarelix 16 mg on Day 0 and Day 14
|
Degarelix 32 mg
A single dose of Degarelix 32 mg on Day 0
|
Degarelix 32+32 mg
Two doses of Degarelix 32 mg on Day 0 and Day 14
|
Degarelix 64 mg
A single dose of Degarelix 64 mg on Day 0
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
13
|
13
|
|
Overall Study
COMPLETED
|
13
|
12
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Degarelix 16+16 mg
Two doses of Degarelix 16 mg on Day 0 and Day 14
|
Degarelix 32 mg
A single dose of Degarelix 32 mg on Day 0
|
Degarelix 32+32 mg
Two doses of Degarelix 32 mg on Day 0 and Day 14
|
Degarelix 64 mg
A single dose of Degarelix 64 mg on Day 0
|
|---|---|---|---|---|
|
Overall Study
Withdrawn prior to dosing
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Explorative Study of Degarelix for Treatment of Benign Prostatic Hyperplasia.
Baseline characteristics by cohort
| Measure |
Degarelix 16+16 mg
n=13 Participants
Two doses of Degarelix 16 mg on Day 0 and Day 14
|
Degarelix 32 mg
n=13 Participants
A single dose of Degarelix 32 mg on Day 0
|
Degarelix 32+32 mg
n=13 Participants
Two doses of Degarelix 32 mg on Day 0 and Day 14
|
Degarelix 64 mg
n=13 Participants
A single dose of Degarelix 64 mg on Day 0
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65.7 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
63.0 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
66.3 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
60.4 years
STANDARD_DEVIATION 7.8 • n=4 Participants
|
63.8 years
STANDARD_DEVIATION 6.2 • 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
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
13 participants
n=5 Participants
|
13 participants
n=4 Participants
|
52 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 0-42 DaysThe area of the testosterone concentration (ng/mL) vs. time (days) curve that is below the baseline interval concentration( i.e. 0.75 x baseline concentration)
Outcome measures
| Measure |
Degarelix 16+16 mg
n=13 Participants
Two doses of Degarelix 16 mg on Day 0 and Day 14
|
Degarelix 32 mg
n=12 Participants
A single dose of Degarelix 32 mg on Day 0
|
Degarelix 32+32 mg
n=12 Participants
Two doses of Degarelix 32 mg on Day 0 and Day 14
|
Degarelix 64 mg
n=13 Participants
A single dose of Degarelix 64 mg on Day 0
|
|---|---|---|---|---|
|
Testosterone Area Below Baseline Interval
|
21.0 ng*days/mL
Standard Deviation 19.1
|
16.0 ng*days/mL
Standard Deviation 11.6
|
54.6 ng*days/mL
Standard Deviation 25.7
|
70.6 ng*days/mL
Standard Deviation 53.9
|
PRIMARY outcome
Timeframe: Day 0-42The time from when the testosterone concentration falls below the baseline interval limit (i.e. 0.75 x baseline concentration) until it returns above this limit
Outcome measures
| Measure |
Degarelix 16+16 mg
n=13 Participants
Two doses of Degarelix 16 mg on Day 0 and Day 14
|
Degarelix 32 mg
n=12 Participants
A single dose of Degarelix 32 mg on Day 0
|
Degarelix 32+32 mg
n=12 Participants
Two doses of Degarelix 32 mg on Day 0 and Day 14
|
Degarelix 64 mg
n=13 Participants
A single dose of Degarelix 64 mg on Day 0
|
|---|---|---|---|---|
|
Time of Testosterone Concentration Below Baseline Interval
|
21.2 Days
Standard Deviation 12.8
|
13.2 Days
Standard Deviation 9.3
|
34.3 Days
Standard Deviation 10.8
|
34.0 Days
Standard Deviation 11.7
|
PRIMARY outcome
Timeframe: Day 0-42The lowest concentration of testosterone measured within the time frame
Outcome measures
| Measure |
Degarelix 16+16 mg
n=13 Participants
Two doses of Degarelix 16 mg on Day 0 and Day 14
|
Degarelix 32 mg
n=12 Participants
A single dose of Degarelix 32 mg on Day 0
|
Degarelix 32+32 mg
n=12 Participants
Two doses of Degarelix 32 mg on Day 0 and Day 14
|
Degarelix 64 mg
n=13 Participants
A single dose of Degarelix 64 mg on Day 0
|
|---|---|---|---|---|
|
Minimal Value of Testosterone (Cnadir)
|
1.4 ng/mL
Standard Deviation 0.5
|
0.9 ng/mL
Standard Deviation 0.5
|
0.4 ng/mL
Standard Deviation 0.3
|
0.4 ng/mL
Standard Deviation 0.2
|
PRIMARY outcome
Timeframe: Day 0-42The time point when the lowest testosterone concentration was measured
Outcome measures
| Measure |
Degarelix 16+16 mg
n=13 Participants
Two doses of Degarelix 16 mg on Day 0 and Day 14
|
Degarelix 32 mg
n=12 Participants
A single dose of Degarelix 32 mg on Day 0
|
Degarelix 32+32 mg
n=12 Participants
Two doses of Degarelix 32 mg on Day 0 and Day 14
|
Degarelix 64 mg
n=13 Participants
A single dose of Degarelix 64 mg on Day 0
|
|---|---|---|---|---|
|
Time of Minimal Value of Testosterone (Tnadir)
|
1.1 Days
Standard Deviation 0.6
|
1.3 Days
Standard Deviation 0.8
|
4.3 Days
Standard Deviation 5.3
|
8.8 Days
Standard Deviation 9.9
|
PRIMARY outcome
Timeframe: Day 0-42The time from when the testosterone concentration falls below 0.5 ng/mL until it returns above that level
Outcome measures
| Measure |
Degarelix 16+16 mg
n=13 Participants
Two doses of Degarelix 16 mg on Day 0 and Day 14
|
Degarelix 32 mg
n=12 Participants
A single dose of Degarelix 32 mg on Day 0
|
Degarelix 32+32 mg
n=12 Participants
Two doses of Degarelix 32 mg on Day 0 and Day 14
|
Degarelix 64 mg
n=13 Participants
A single dose of Degarelix 64 mg on Day 0
|
|---|---|---|---|---|
|
Duration of Testosterone Concentration Below 0.5 ng/mL
|
0.0 Days
Interval 0.0 to 0.2
|
0.0 Days
Interval 0.0 to 2.2
|
1.4 Days
Interval 0.0 to 41.1
|
2.0 Days
Interval 0.0 to 41.1
|
PRIMARY outcome
Timeframe: Day 0-42Outcome measures
| Measure |
Degarelix 16+16 mg
n=13 Participants
Two doses of Degarelix 16 mg on Day 0 and Day 14
|
Degarelix 32 mg
n=12 Participants
A single dose of Degarelix 32 mg on Day 0
|
Degarelix 32+32 mg
n=12 Participants
Two doses of Degarelix 32 mg on Day 0 and Day 14
|
Degarelix 64 mg
n=13 Participants
A single dose of Degarelix 64 mg on Day 0
|
|---|---|---|---|---|
|
Number of Subjects With Testosterone Concentration ≤0.5 ng/mL
Day 1
|
0 participants
|
2 participants
|
5 participants
|
8 participants
|
|
Number of Subjects With Testosterone Concentration ≤0.5 ng/mL
Day 5
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
|
Number of Subjects With Testosterone Concentration ≤0.5 ng/mL
Day 14
|
0 participants
|
0 participants
|
1 participants
|
5 participants
|
|
Number of Subjects With Testosterone Concentration ≤0.5 ng/mL
Day 17
|
0 participants
|
0 participants
|
8 participants
|
5 participants
|
|
Number of Subjects With Testosterone Concentration ≤0.5 ng/mL
Day 28
|
0 participants
|
0 participants
|
3 participants
|
5 participants
|
|
Number of Subjects With Testosterone Concentration ≤0.5 ng/mL
Day 42
|
0 participants
|
0 participants
|
3 participants
|
5 participants
|
PRIMARY outcome
Timeframe: Day 0-42The baseline interval concentration is 0.75 x baseline concentration
Outcome measures
| Measure |
Degarelix 16+16 mg
n=13 Participants
Two doses of Degarelix 16 mg on Day 0 and Day 14
|
Degarelix 32 mg
n=12 Participants
A single dose of Degarelix 32 mg on Day 0
|
Degarelix 32+32 mg
n=12 Participants
Two doses of Degarelix 32 mg on Day 0 and Day 14
|
Degarelix 64 mg
n=13 Participants
A single dose of Degarelix 64 mg on Day 0
|
|---|---|---|---|---|
|
Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration
Day 1
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration
Day14
|
11 participants
|
10 participants
|
7 participants
|
2 participants
|
|
Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration
Day 28
|
8 participants
|
9 participants
|
3 participants
|
3 participants
|
|
Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration
Day 42
|
8 participants
|
12 participants
|
3 participants
|
4 participants
|
PRIMARY outcome
Timeframe: Day 0-42Outcome measures
| Measure |
Degarelix 16+16 mg
n=13 Participants
Two doses of Degarelix 16 mg on Day 0 and Day 14
|
Degarelix 32 mg
n=12 Participants
A single dose of Degarelix 32 mg on Day 0
|
Degarelix 32+32 mg
n=12 Participants
Two doses of Degarelix 32 mg on Day 0 and Day 14
|
Degarelix 64 mg
n=13 Participants
A single dose of Degarelix 64 mg on Day 0
|
|---|---|---|---|---|
|
Prostate Specific Antigen (PSA) Concentration
Baseline
|
3.9 ng/mL
Standard Deviation 3.2
|
3.0 ng/mL
Standard Deviation 2.6
|
2.8 ng/mL
Standard Deviation 2.5
|
3.2 ng/mL
Standard Deviation 3.1
|
|
Prostate Specific Antigen (PSA) Concentration
Day 42
|
3.7 ng/mL
Standard Deviation 2.5
|
2.5 ng/mL
Standard Deviation 1.7
|
2.4 ng/mL
Standard Deviation 2.6
|
2.3 ng/mL
Standard Deviation 1.9
|
PRIMARY outcome
Timeframe: Day 0-42The prostatic volume was measured by transrectal ultrasound. The prostatic gland was sonicated from two directions perpendicular to one another resulting in three cursor positions set by the urologist, and the volume automatically calculated.
Outcome measures
| Measure |
Degarelix 16+16 mg
n=13 Participants
Two doses of Degarelix 16 mg on Day 0 and Day 14
|
Degarelix 32 mg
n=12 Participants
A single dose of Degarelix 32 mg on Day 0
|
Degarelix 32+32 mg
n=12 Participants
Two doses of Degarelix 32 mg on Day 0 and Day 14
|
Degarelix 64 mg
n=13 Participants
A single dose of Degarelix 64 mg on Day 0
|
|---|---|---|---|---|
|
Prostate Volume
Baseline
|
42.0 mL
Standard Deviation 12.1
|
48.7 mL
Standard Deviation 21.0
|
38.1 mL
Standard Deviation 7.1
|
38.9 mL
Standard Deviation 9.0
|
|
Prostate Volume
Day 42
|
34.5 mL
Standard Deviation 11.0
|
34.8 mL
Standard Deviation 14.2
|
28.7 mL
Standard Deviation 8.2
|
30.6 mL
Standard Deviation 10.5
|
PRIMARY outcome
Timeframe: Day 0-42Urinary flow was determined by flowmetry using a device that fulfils the International Continence Society standards for maximum urinary flow.
Outcome measures
| Measure |
Degarelix 16+16 mg
n=13 Participants
Two doses of Degarelix 16 mg on Day 0 and Day 14
|
Degarelix 32 mg
n=12 Participants
A single dose of Degarelix 32 mg on Day 0
|
Degarelix 32+32 mg
n=12 Participants
Two doses of Degarelix 32 mg on Day 0 and Day 14
|
Degarelix 64 mg
n=13 Participants
A single dose of Degarelix 64 mg on Day 0
|
|---|---|---|---|---|
|
Maximal Urinary Flow
Baseline
|
10.0 mL/s
Standard Deviation 4.7
|
11.7 mL/s
Standard Deviation 3.4
|
9.7 mL/s
Standard Deviation 4.1
|
9.1 mL/s
Standard Deviation 3.0
|
|
Maximal Urinary Flow
Day 42
|
10.1 mL/s
Standard Deviation 4.3
|
11.2 mL/s
Standard Deviation 4.0
|
12.2 mL/s
Standard Deviation 9.3
|
11.9 mL/s
Standard Deviation 9.1
|
PRIMARY outcome
Timeframe: Day 0-42The post-void residual urine volume in the bladder was evaluated by transabdominal ultrasound. The urine bladder was sonicated from two directions perpendicular to one another, and the volume calculated automatically.
Outcome measures
| Measure |
Degarelix 16+16 mg
n=13 Participants
Two doses of Degarelix 16 mg on Day 0 and Day 14
|
Degarelix 32 mg
n=12 Participants
A single dose of Degarelix 32 mg on Day 0
|
Degarelix 32+32 mg
n=12 Participants
Two doses of Degarelix 32 mg on Day 0 and Day 14
|
Degarelix 64 mg
n=13 Participants
A single dose of Degarelix 64 mg on Day 0
|
|---|---|---|---|---|
|
Post-void Residual Urine Volume
Baseline
|
63.4 mL
Interval 4.8 to 170.0
|
60.7 mL
Interval 0.0 to 157.0
|
56.7 mL
Interval 8.4 to 201.0
|
91.3 mL
Interval 4.6 to 368.0
|
|
Post-void Residual Urine Volume
Day 42
|
58.0 mL
Interval 0.3 to 215.0
|
45.2 mL
Interval 0.0 to 108.0
|
34.6 mL
Interval 0.0 to 165.0
|
75.8 mL
Interval 0.0 to 259.0
|
PRIMARY outcome
Timeframe: Day 0-42The IPSS is a patient-administered questionnaire containing seven items to evaluate symptoms of urinary obstruction (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, nocturia) over the preceding week. Each urinary symptom question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (0-7: mildly symptomatic; 8-19: moderately symptomatic; 20-35: severely symptomatic).
Outcome measures
| Measure |
Degarelix 16+16 mg
n=13 Participants
Two doses of Degarelix 16 mg on Day 0 and Day 14
|
Degarelix 32 mg
n=12 Participants
A single dose of Degarelix 32 mg on Day 0
|
Degarelix 32+32 mg
n=12 Participants
Two doses of Degarelix 32 mg on Day 0 and Day 14
|
Degarelix 64 mg
n=13 Participants
A single dose of Degarelix 64 mg on Day 0
|
|---|---|---|---|---|
|
International Prostate Specific Symptom (IPSS) Score
Baseline
|
17.7 Units on a scale
Standard Deviation 4.5
|
22.3 Units on a scale
Standard Deviation 6.5
|
18.2 Units on a scale
Standard Deviation 5.4
|
21.8 Units on a scale
Standard Deviation 6.2
|
|
International Prostate Specific Symptom (IPSS) Score
Day 42
|
11.6 Units on a scale
Standard Deviation 4.5
|
9.1 Units on a scale
Standard Deviation 6.2
|
8.6 Units on a scale
Standard Deviation 5.7
|
11.8 Units on a scale
Standard Deviation 5.9
|
PRIMARY outcome
Timeframe: Day 0-42Patients were asked about how they would feel if they were to spend the rest of their lives with their prostate symptoms just as they are now. The answers choices range from "delighted" to "terrible" or 0 to 6.
Outcome measures
| Measure |
Degarelix 16+16 mg
n=13 Participants
Two doses of Degarelix 16 mg on Day 0 and Day 14
|
Degarelix 32 mg
n=12 Participants
A single dose of Degarelix 32 mg on Day 0
|
Degarelix 32+32 mg
n=12 Participants
Two doses of Degarelix 32 mg on Day 0 and Day 14
|
Degarelix 64 mg
n=13 Participants
A single dose of Degarelix 64 mg on Day 0
|
|---|---|---|---|---|
|
IPSS Global Quality of Life
Baseline
|
4.2 Units on a scale
Standard Deviation 1.1
|
3.8 Units on a scale
Standard Deviation 1.7
|
4.3 Units on a scale
Standard Deviation 1.3
|
4.7 Units on a scale
Standard Deviation 1.4
|
|
IPSS Global Quality of Life
Day 42
|
2.9 Units on a scale
Standard Deviation 1.4
|
1.8 Units on a scale
Standard Deviation 2.0
|
1.9 Units on a scale
Standard Deviation 1.6
|
2.5 Units on a scale
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: Day 0-42The IIEF contains 15 items in 5 domains: Erectile Function (6 items), Orgasmic Function (2 items), Sexual Desire (2 items), Intercourse Satisfaction (3 items), and Overall Satisfaction (2 items). Item are scored on a scale from 'No sexual activity' to 'Almost always to always'. For the Erectile Function domain, a score of 1-10 indicates severe erectile dysfunction and 26-30 no dysfunction, the minimum score being 1 and the maximum 30. For all other domains, a higher score indicates less dysfunction. The IIEF does not yield a total score.
Outcome measures
| Measure |
Degarelix 16+16 mg
n=13 Participants
Two doses of Degarelix 16 mg on Day 0 and Day 14
|
Degarelix 32 mg
n=12 Participants
A single dose of Degarelix 32 mg on Day 0
|
Degarelix 32+32 mg
n=12 Participants
Two doses of Degarelix 32 mg on Day 0 and Day 14
|
Degarelix 64 mg
n=13 Participants
A single dose of Degarelix 64 mg on Day 0
|
|---|---|---|---|---|
|
Interntional Iindes of Erectile Function (IIEF) Score: Overall Satisfaction
Baseline
|
6.6 Units on a scale
Standard Deviation 1.8
|
6.5 Units on a scale
Standard Deviation 2.5
|
5.8 Units on a scale
Standard Deviation 2.6
|
5.9 Units on a scale
Standard Deviation 2.8
|
|
Interntional Iindes of Erectile Function (IIEF) Score: Overall Satisfaction
Day 42
|
6.8 Units on a scale
Standard Deviation 1.8
|
6.2 Units on a scale
Standard Deviation 3.2
|
6.0 Units on a scale
Standard Deviation 3.0
|
5.1 Units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 0-42 DaysArea under the time-concentration curve (AUCt) was calculated by non-compartmental methods based on data up to Day 42
Outcome measures
| Measure |
Degarelix 16+16 mg
n=13 Participants
Two doses of Degarelix 16 mg on Day 0 and Day 14
|
Degarelix 32 mg
n=12 Participants
A single dose of Degarelix 32 mg on Day 0
|
Degarelix 32+32 mg
n=12 Participants
Two doses of Degarelix 32 mg on Day 0 and Day 14
|
Degarelix 64 mg
n=13 Participants
A single dose of Degarelix 64 mg on Day 0
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters of Degarelix: AUCt
|
70.7 ng*day/mL
Standard Deviation 20.6
|
86.9 ng*day/mL
Standard Deviation 26.9
|
158 ng*day/mL
Standard Deviation 43.7
|
176 ng*day/mL
Standard Deviation 47.2
|
SECONDARY outcome
Timeframe: Day 0-42Cmax was determined for concentration measurements up to Day 42
Outcome measures
| Measure |
Degarelix 16+16 mg
n=13 Participants
Two doses of Degarelix 16 mg on Day 0 and Day 14
|
Degarelix 32 mg
n=12 Participants
A single dose of Degarelix 32 mg on Day 0
|
Degarelix 32+32 mg
n=12 Participants
Two doses of Degarelix 32 mg on Day 0 and Day 14
|
Degarelix 64 mg
n=13 Participants
A single dose of Degarelix 64 mg on Day 0
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters of Degarelix: Cmax
|
4.5 ng/mL
Standard Deviation 1.2
|
6.9 ng/mL
Standard Deviation 1.9
|
9.6 ng/mL
Standard Deviation 3.0
|
15.8 ng/mL
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: Day 0-42The time for maximal concentration (tmax) was determined for data up to Day 42
Outcome measures
| Measure |
Degarelix 16+16 mg
n=13 Participants
Two doses of Degarelix 16 mg on Day 0 and Day 14
|
Degarelix 32 mg
n=12 Participants
A single dose of Degarelix 32 mg on Day 0
|
Degarelix 32+32 mg
n=12 Participants
Two doses of Degarelix 32 mg on Day 0 and Day 14
|
Degarelix 64 mg
n=13 Participants
A single dose of Degarelix 64 mg on Day 0
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters of Degarelix: Tmax
|
1.0 Days
Standard Deviation 0.0
|
1.3 Days
Standard Deviation 0.8
|
1.1 Days
Standard Deviation 0.6
|
1.1 Days
Standard Deviation 0.6
|
Adverse Events
Degarelix 16+16 mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Degarelix 32 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Degarelix 32+32 mg
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Degarelix 64 mg
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Degarelix 16+16 mg
n=13 participants at risk
Two doses of Degarelix 16 mg on Day 0 and Day 14
|
Degarelix 32 mg
n=12 participants at risk
A single dose of Degarelix 32 mg on Day 0
|
Degarelix 32+32 mg
n=12 participants at risk
Two doses of Degarelix 32 mg on Day 0 and Day 14
|
Degarelix 64 mg
n=13 participants at risk
A single dose of Degarelix 64 mg on Day 0
|
|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/13 • Day 0-42
|
0.00%
0/12 • Day 0-42
|
8.3%
1/12 • Number of events 1 • Day 0-42
|
0.00%
0/13 • Day 0-42
|
|
Nervous system disorders
Syncope
|
0.00%
0/13 • Day 0-42
|
0.00%
0/12 • Day 0-42
|
0.00%
0/12 • Day 0-42
|
7.7%
1/13 • Number of events 1 • Day 0-42
|
Other adverse events
| Measure |
Degarelix 16+16 mg
n=13 participants at risk
Two doses of Degarelix 16 mg on Day 0 and Day 14
|
Degarelix 32 mg
n=12 participants at risk
A single dose of Degarelix 32 mg on Day 0
|
Degarelix 32+32 mg
n=12 participants at risk
Two doses of Degarelix 32 mg on Day 0 and Day 14
|
Degarelix 64 mg
n=13 participants at risk
A single dose of Degarelix 64 mg on Day 0
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Injection site reaction
|
84.6%
11/13 • Number of events 29 • Day 0-42
|
91.7%
11/12 • Number of events 25 • Day 0-42
|
100.0%
12/12 • Number of events 39 • Day 0-42
|
100.0%
13/13 • Number of events 37 • Day 0-42
|
|
Nervous system disorders
Headache
|
0.00%
0/13 • Day 0-42
|
8.3%
1/12 • Number of events 1 • Day 0-42
|
0.00%
0/12 • Day 0-42
|
0.00%
0/13 • Day 0-42
|
|
Psychiatric disorders
Loss of libido
|
0.00%
0/13 • Day 0-42
|
0.00%
0/12 • Day 0-42
|
8.3%
1/12 • Number of events 1 • Day 0-42
|
15.4%
2/13 • Number of events 2 • Day 0-42
|
|
Psychiatric disorders
Libido increased
|
0.00%
0/13 • Day 0-42
|
0.00%
0/12 • Day 0-42
|
0.00%
0/12 • Day 0-42
|
7.7%
1/13 • Number of events 1 • Day 0-42
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/13 • Day 0-42
|
8.3%
1/12 • Number of events 2 • Day 0-42
|
0.00%
0/12 • Day 0-42
|
0.00%
0/13 • Day 0-42
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
7.7%
1/13 • Number of events 1 • Day 0-42
|
0.00%
0/12 • Day 0-42
|
8.3%
1/12 • Number of events 1 • Day 0-42
|
7.7%
1/13 • Number of events 1 • Day 0-42
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/13 • Day 0-42
|
0.00%
0/12 • Day 0-42
|
0.00%
0/12 • Day 0-42
|
7.7%
1/13 • Number of events 1 • Day 0-42
|
|
Vascular disorders
Hot flush
|
7.7%
1/13 • Number of events 1 • Day 0-42
|
8.3%
1/12 • Number of events 1 • Day 0-42
|
16.7%
2/12 • Number of events 2 • Day 0-42
|
15.4%
2/13 • Number of events 5 • Day 0-42
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After the end of the study, one or more manuscripts for joint publication may be prepared in collaboration between the investigator(s) offered authorship and Ferring Pharmaceuticals A/S (Ferring). Ferring reserves the right to be last author(s) in all publications related to this study. In the event of any disagreement in the content of any publication, both the Investigator's and Ferring's opinion will be fairly and sufficiently represented in the publication.
- Publication restrictions are in place
Restriction type: OTHER