Trial Outcomes & Findings for Intermittent Treatment With Degarelix of Patients Suffering From Prostate Cancer (NCT NCT00801242)
NCT ID: NCT00801242
Last Updated: 2014-09-03
Results Overview
Blood samples for analyses of serum PSA levels were collected at the Screening Visit, and every two months during the course of the trial, and at the End-of-Trial Visit. Analyses were performed using chemiluminometric immunoassay.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
220 participants
Primary outcome timeframe
Up to 24 months after end of induction period
Results posted on
2014-09-03
Participant Flow
Participant milestones
| Measure |
Degarelix 240 mg / 80 mg
Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
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|---|---|
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Overall Study
STARTED
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220
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Overall Study
Safety Analysis Set
|
216
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Overall Study
Full Analysis Set (FAS), Cycle 1
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213
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Overall Study
FAS, Off-treatment Cycle 1
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191
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Overall Study
Started Cycle 2
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35
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Overall Study
Started Cycle 3
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2
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Overall Study
COMPLETED
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168
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Overall Study
NOT COMPLETED
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52
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Reasons for withdrawal
| Measure |
Degarelix 240 mg / 80 mg
Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
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|---|---|
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Overall Study
Adverse Event
|
10
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Overall Study
Withdrawal by Subject
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13
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Overall Study
Protocol Violation
|
5
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Overall Study
Physician Decision
|
3
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Overall Study
Lost to Follow-up
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1
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Overall Study
Miscellaneous reasons
|
20
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Baseline Characteristics
Intermittent Treatment With Degarelix of Patients Suffering From Prostate Cancer
Baseline characteristics by cohort
| Measure |
Degarelix 240 mg / 80 mg
n=213 Participants
Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
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|---|---|
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Age, Continuous
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73.1 years
STANDARD_DEVIATION 7.73 • n=5 Participants
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Sex: Female, Male
Female
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0 Participants
n=5 Participants
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Sex: Female, Male
Male
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213 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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212 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
France
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43 participants
n=5 Participants
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Region of Enrollment
Spain
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24 participants
n=5 Participants
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Region of Enrollment
Belgium
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26 participants
n=5 Participants
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Region of Enrollment
Netherlands
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25 participants
n=5 Participants
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Region of Enrollment
Germany
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63 participants
n=5 Participants
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Region of Enrollment
Italy
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32 participants
n=5 Participants
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Median Baseline Serum Testosterone Levels
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4.09 ng/mL
n=5 Participants
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Median Baseline Serum Prostate-specific Antigen Levels
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7.9 ng/mL
n=5 Participants
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Baseline EORTC QLQ-PR25 Scores during Cycle 1
Urinary Symptoms
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23.1 units on a scale
STANDARD_DEVIATION 16.0 • n=5 Participants
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Baseline EORTC QLQ-PR25 Scores during Cycle 1
Bother due to Incontinence aid
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18.5 units on a scale
STANDARD_DEVIATION 28.0 • n=5 Participants
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Baseline EORTC QLQ-PR25 Scores during Cycle 1
Bowel Symptoms
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4.05 units on a scale
STANDARD_DEVIATION 9.65 • n=5 Participants
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Baseline EORTC QLQ-PR25 Scores during Cycle 1
Hormonal Treatment-related Symptoms
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7.09 units on a scale
STANDARD_DEVIATION 10.4 • n=5 Participants
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Baseline EORTC QLQ-PR25 Scores during Cycle 1
Sexual Activity
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58.0 units on a scale
STANDARD_DEVIATION 26.8 • n=5 Participants
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Baseline EORTC QLQ-PR25 Scores during Cycle 1
Sexual Functioning
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25.8 units on a scale
STANDARD_DEVIATION 26.7 • n=5 Participants
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Baseline IIEF Scores during Cycle 1
Erectile Function
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7.02 units on a scale
STANDARD_DEVIATION 8.96 • n=5 Participants
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Baseline IIEF Scores during Cycle 1
Orgasmic Function
|
2.31 units on a scale
STANDARD_DEVIATION 3.43 • n=5 Participants
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Baseline IIEF Scores during Cycle 1
Sexual Desire
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4.22 units on a scale
STANDARD_DEVIATION 2.26 • n=5 Participants
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Baseline IIEF Scores during Cycle 1
Intercourse Satisfaction
|
2.65 units on a scale
STANDARD_DEVIATION 4.2 • n=5 Participants
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Baseline IIEF Scores during Cycle 1
Overall Satisfaction
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5.17 units on a scale
STANDARD_DEVIATION 2.91 • n=5 Participants
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PRIMARY outcome
Timeframe: Up to 24 months after end of induction periodPopulation: FAS, Off-treatment Cycle 1, i.e. a subset of all FAS participants who completed the 7 months' induction treatment period of the first cycle and were enrolled in the off-treatment period (of the first cycle) and had at least one efficacy assessment (i.e. PSA or testosterone determination) during the off-treatment period.
Blood samples for analyses of serum PSA levels were collected at the Screening Visit, and every two months during the course of the trial, and at the End-of-Trial Visit. Analyses were performed using chemiluminometric immunoassay.
Outcome measures
| Measure |
Degarelix 240 mg / 80 mg
n=191 Participants
Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
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Median and Between Participant Variability of Time to Prostate-specific Antigen (PSA) >4 ng/mL During the First Cycle of Intermittent Androgen Deprivation (IAD) After 7 Monthly Injections of Degarelix Induction Treatment
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392 days
Interval 336.0 to 448.0
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SECONDARY outcome
Timeframe: 7 monthsPopulation: FAS, Cycle 1.
Outcome measures
| Measure |
Degarelix 240 mg / 80 mg
n=213 Participants
Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
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|---|---|
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Percentage Change in PSA Serum Levels From Baseline to the Last Visit of the Induction Period During the First Cycle of IAD
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-90.8 percentage of baseline
Standard Deviation 16.6
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SECONDARY outcome
Timeframe: Up to 24 months after end of induction periodPopulation: FAS, Off-treatment Cycle 1.
Blood samples for analyses of serum testosterone levels were collected at the Screening Visit, Month 4 and 7 of the induction period of Cycle 1 and the corresponding visits of any additional treatment cycles, every two months during the off-treatment period(s), and at the End-of-Trial Visit. Analyses were performed using Liquid-Liquid Extraction and Liquid Chromatography-Mass Spectrometry/Mass Spectrometry.
Outcome measures
| Measure |
Degarelix 240 mg / 80 mg
n=191 Participants
Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
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|---|---|
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Median and Between Participant Variability of Time to Return to Testosterone >0.5 ng/mL (Above Castration Level) During the First Cycle of IAD After 7 Monthly Injections of Degarelix Induction Treatment
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112 days
Interval 112.0 to 168.0
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SECONDARY outcome
Timeframe: 7 monthsPopulation: FAS, Cycle 1.
Outcome measures
| Measure |
Degarelix 240 mg / 80 mg
n=213 Participants
Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
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|---|---|
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Number of Participants With Testosterone ≤0.5 ng/mL at the Last Visit of the Induction Period During the First Cycle of IAD
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210 participants
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SECONDARY outcome
Timeframe: Up to 31 monthsPopulation: FAS, Cycle 1
The EORTC QLQ-PR25 employs a modular approach towards assessing cancer patients´ health-related Quality of Life (QoL) and assesses urinary, bowel, and sexual symptoms and functioning, and the side-effects of hormonal treatment. It consists of 25 questions distributed on six domains (number of items per domain, ranges from x to y: urinary symptoms (8, 0-100), bother due to use of incontinence aid (1, 0-100), bowel symptoms (4, 0-100), hormonal treatment-related symptoms (6, 0-100), sexual activity (2, 0-100), and sexual functioning (4, 0-100). All raw domain scores are linearly transformed to a 0-100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual).
Outcome measures
| Measure |
Degarelix 240 mg / 80 mg
n=213 Participants
Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
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|---|---|
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Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD
Sexual Activity, End of Induction
|
55.1 units on a scale
Standard Deviation 27.2
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Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD
Urinary Symptoms, End of Induction
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24.5 units on a scale
Standard Deviation 18.0
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|
Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD
Urinary Symptoms, End of Cycle 1
|
21.2 units on a scale
Standard Deviation 16.7
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Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD
Bother, End of Induction
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17.9 units on a scale
Standard Deviation 29.1
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Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD
Bother, End of Cycle 1
|
31 units on a scale
Standard Deviation 34.4
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Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD
Bowel Symptoms, End of Induction
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4.84 units on a scale
Standard Deviation 10.2
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Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD
Bowel Symptoms, End of Cycle 1
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4.98 units on a scale
Standard Deviation 8.34
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Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD
Treatment-related Symptoms, End of Induction
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17.6 units on a scale
Standard Deviation 14.5
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|
Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD
Treatment-related Symptoms, End of Cycle 1
|
13.2 units on a scale
Standard Deviation 13.0
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|
Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD
Sexual Activity, End of Cycle 1
|
56.7 units on a scale
Standard Deviation 26.6
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Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD
Sexual Functioning, End of Induction
|
10.9 units on a scale
Standard Deviation 17.7
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|
Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD
Sexual Functioning, End of Cycle 1
|
17.7 units on a scale
Standard Deviation 22.6
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SECONDARY outcome
Timeframe: Up to 31 monthsPopulation: FAS, Cycle 1.
The IIEF scale addresses the relevant domains of male sexual function (i.e. erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction). The IIEF scale is psychometrically sound, and has been linguistically validated in multiple languages. The IIEF scale demonstrates the sensitivity and specificity for detecting treatment-related changes in patients with erectile dysfunction. It consists of the following domains (number of items per domain; ranges from x to y: erectile function (6; 1-30), orgasmic function (2; 0-10), sexual desire (2; 2-10), intercourse satisfaction (3; 0-15) and overall satisfaction (2; 2-10). For all domains, a higher score represents a better sexual function.
Outcome measures
| Measure |
Degarelix 240 mg / 80 mg
n=213 Participants
Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
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|---|---|
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Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD
Erectile Function, End of Induction
|
3.1 units on a scale
Standard Deviation 5
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|
Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD
Erectile Function, End of Cycle 1
|
5.35 units on a scale
Standard Deviation 8.21
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|
Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD
Orgasmic Function, End of Induction
|
0.665 units on a scale
Standard Deviation 1.81
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|
Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD
Orgasmic Function, End of Cycle 1
|
1.76 units on a scale
Standard Deviation 3.03
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|
Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD
Sexual Desire, End of Induction
|
2.84 units on a scale
Standard Deviation 1.47
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Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD
Sexual Desire, End of Cycle 1
|
3.77 units on a scale
Standard Deviation 2.17
|
|
Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD
Intercourse Satisfaction, End of Induction
|
0.801 units on a scale
Standard Deviation 2.21
|
|
Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD
Intercourse Satisfaction, End of Cycle 1
|
2.01 units on a scale
Standard Deviation 3.69
|
|
Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD
Overall Satisfaction, End of Induction
|
4.5 units on a scale
Standard Deviation 2.9
|
|
Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD
Overall Satisfaction, End of Cycle 1
|
4.97 units on a scale
Standard Deviation 3.12
|
SECONDARY outcome
Timeframe: Up to 3 x 31 monthsPopulation: Safety Analysis Set.
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 during the trial.
Outcome measures
| Measure |
Degarelix 240 mg / 80 mg
n=216 Participants
Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
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|---|---|
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Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment
Systolic blood pressure ≤90 and decrease ≥20
|
4 participants
|
|
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment
Systolic blood pressure ≥180 and increase ≥20
|
13 participants
|
|
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment
Diastolic blood pressure ≤50 and decrease ≥15
|
2 participants
|
|
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment
Diastolic blood pressure ≥105 and increase ≥15
|
8 participants
|
|
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment
Heart rate ≤50 and decrease ≥15
|
4 participants
|
|
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment
Heart rate ≥120 and increase ≥15
|
0 participants
|
|
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment
Body weight decrease of ≥7 percent
|
14 participants
|
|
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment
Body weight increase of ≥7 percent
|
23 participants
|
SECONDARY outcome
Timeframe: Up to 3 x 31 monthsPopulation: Safety Analysis Set.
This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value during the trial. ULN=Upper limit of normal.
Outcome measures
| Measure |
Degarelix 240 mg / 80 mg
n=216 Participants
Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
|
|---|---|
|
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment
S-Alanine Aminotransferase, >3xULN
|
2 participants
|
|
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment
S-Alkaline Phosphatase, >3xULN and 25% increase
|
1 participants
|
|
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment
S-Aspartate Aminotransferase, >3xULN
|
2 participants
|
|
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment
S-Calcium, ≤1.8 mmol/L
|
1 participants
|
|
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment
S-Creatinine, ≥177 (µmol/L)
|
1 participants
|
|
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment
S-Glutamyltransferase, >3xULN
|
1 participants
|
|
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment
S-Potassium, ≥5.8 mmol/L)
|
3 participants
|
|
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment
S-Total Bilirubin, >1.5xULN
|
1 participants
|
|
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment
S-Urea Nitrogen, >10.7 mmol/L
|
24 participants
|
|
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment
S-Sodium, ≤130 mmol/L
|
1 participants
|
Adverse Events
Degarelix 240 mg / 80 mg
Serious events: 51 serious events
Other events: 185 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Degarelix 240 mg / 80 mg
n=216 participants at risk
Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix at a concentration of 40 mg/mL was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix at a concentration of 20 mg/mL were administered 28 days apart via single s.c. injections.
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|---|---|
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Cardiac disorders
Cardiac Failure
|
0.93%
2/216 • 3 x 31 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.
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.93%
2/216 • 3 x 31 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.
|
|
Cardiac disorders
Myocardial Infarction
|
0.93%
2/216 • 3 x 31 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.
|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.46%
1/216 • 3 x 31 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.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.46%
1/216 • 3 x 31 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.
|
|
Cardiac disorders
Diastolic Dysfunction
|
0.46%
1/216 • 3 x 31 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.
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.46%
1/216 • 3 x 31 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.
|
|
Ear and labyrinth disorders
Vertigo
|
0.46%
1/216 • 3 x 31 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.
|
|
Eye disorders
Blindness Transient
|
0.46%
1/216 • 3 x 31 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
Gastric Ulcer
|
0.93%
2/216 • 3 x 31 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
Inguinal Hernia
|
0.93%
2/216 • 3 x 31 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
Gastrointestinal Haemorrhage
|
0.93%
2/216 • 3 x 31 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
Tongue Disorder
|
0.46%
1/216 • 3 x 31 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
Chest Pain
|
0.46%
1/216 • 3 x 31 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 Oedema
|
0.46%
1/216 • 3 x 31 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
|
0.46%
1/216 • 3 x 31 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
|
0.46%
1/216 • 3 x 31 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
Oedema Peripheral
|
0.46%
1/216 • 3 x 31 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.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.46%
1/216 • 3 x 31 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
Pneumonia
|
0.93%
2/216 • 3 x 31 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
Abscess
|
0.46%
1/216 • 3 x 31 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
Gastroenteritis Viral
|
0.46%
1/216 • 3 x 31 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
Lung Infection
|
0.46%
1/216 • 3 x 31 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
Pneumocystis Jiroveci Pneumonia
|
0.46%
1/216 • 3 x 31 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
Pyelonephritis Acute
|
0.46%
1/216 • 3 x 31 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
|
0.46%
1/216 • 3 x 31 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
Erysipelas
|
0.46%
1/216 • 3 x 31 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.
|
|
Injury, poisoning and procedural complications
Dislocation of Joint Prosthesis
|
0.46%
1/216 • 3 x 31 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.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.46%
1/216 • 3 x 31 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
Osteoarthritis
|
1.9%
4/216 • 3 x 31 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
Intervertebral Disc Protrusion
|
0.46%
1/216 • 3 x 31 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
Pain in Extremity
|
0.46%
1/216 • 3 x 31 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
Polyarthritis
|
0.46%
1/216 • 3 x 31 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
Synovial Cyst
|
0.46%
1/216 • 3 x 31 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile Duct Cancer
|
0.46%
1/216 • 3 x 31 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.46%
1/216 • 3 x 31 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's Lymphoma
|
0.46%
1/216 • 3 x 31 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer Recurrent
|
0.46%
1/216 • 3 x 31 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of Skin
|
0.46%
1/216 • 3 x 31 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.46%
1/216 • 3 x 31 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
Carotid Artery Stenosis
|
0.93%
2/216 • 3 x 31 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
Cerebral Infarction
|
0.46%
1/216 • 3 x 31 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
Brain Stem Ischaemia
|
0.46%
1/216 • 3 x 31 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
Cerebral Ischaemia
|
0.46%
1/216 • 3 x 31 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
Dementia
|
0.46%
1/216 • 3 x 31 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
Embolic Cerebral Infarction
|
0.46%
1/216 • 3 x 31 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
Neuropathy
|
0.46%
1/216 • 3 x 31 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
Delirium
|
0.46%
1/216 • 3 x 31 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
Bladder Neck Sclerosis
|
0.46%
1/216 • 3 x 31 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
Haematuria
|
0.46%
1/216 • 3 x 31 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
|
0.46%
1/216 • 3 x 31 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
Renal Artery Stenosis
|
0.46%
1/216 • 3 x 31 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
Renal Failure
|
0.46%
1/216 • 3 x 31 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
Urethral Stenosis
|
0.46%
1/216 • 3 x 31 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
Urinary Retention
|
0.46%
1/216 • 3 x 31 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
Urinary Tract Pain
|
0.46%
1/216 • 3 x 31 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.93%
2/216 • 3 x 31 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.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.46%
1/216 • 3 x 31 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.46%
1/216 • 3 x 31 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
Vascular Pseudoaneurysm
|
0.46%
1/216 • 3 x 31 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
Hypotension
|
0.46%
1/216 • 3 x 31 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.
|
Other adverse events
| Measure |
Degarelix 240 mg / 80 mg
n=216 participants at risk
Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix at a concentration of 40 mg/mL was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix at a concentration of 20 mg/mL were administered 28 days apart via single s.c. injections.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.4%
16/216 • 3 x 31 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
|
33.8%
73/216 • 3 x 31 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
|
29.2%
63/216 • 3 x 31 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
|
22.2%
48/216 • 3 x 31 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
|
14.4%
31/216 • 3 x 31 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
|
13.9%
30/216 • 3 x 31 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
Oedema Peripheral
|
6.0%
13/216 • 3 x 31 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
Asthenia
|
5.6%
12/216 • 3 x 31 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 Pruritus
|
5.1%
11/216 • 3 x 31 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
|
11.1%
24/216 • 3 x 31 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
|
13.4%
29/216 • 3 x 31 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
|
6.9%
15/216 • 3 x 31 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
Headache
|
5.1%
11/216 • 3 x 31 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
|
5.6%
12/216 • 3 x 31 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
|
49.5%
107/216 • 3 x 31 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
|
10.2%
22/216 • 3 x 31 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.
|
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. Additional time may be required to allow Ferring to seek patent protection of the invention.
- Publication restrictions are in place
Restriction type: OTHER