BPH
Conditions
Keywords
Benign Prostate Hyperplasia, BPH, PK/PD, GnRH antagonist
Brief summary
This exploratory study will be conducted open label in a single investigational clinical unit. Altogether 52 patients with benign prostate hyperplasia (BPH) will be randomly assigned to receive 4 different treatments with degarelix.
Detailed description
The present study aims at exploring the potential of the currently available formulation of degarelix to treat BPH with only a short transient lowering of the serum testosterone concentration to or below the castration level defined as 0.5 ng/mL. Two doses and two dosing regimens (32 and 64 mg administered either as a single administration or as two administrations separated by 14 days) will be evaluated for 42 days.
Interventions
DRUGDegarelix
Two doses of 16 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days.
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
55 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Each patient must comply with all of the following inclusion criteria to be allowed to be randomised into the study: 1. Man, 55 to 75 years of age. 2. Clinical diagnose of BPH with a prostate volume more than 30 mL, a maximal uroflow of 12 mL/sec or less and an international prostate sympton score (IPSS) of 13 or more at screening. 3. A prostate specific antigen (PSA) value less than 10 ng/mL and no clinical evidence of adenocarcinoma of the prostate at screening. If a biopsy of the prostate is performed, a period of 6 weeks should be allowed after the biopsy before the patient is enrolled into the study. 4. Has a baseline testosterone level above 3 ng/mL at screening.
Exclusion criteria
Any patient meeting one or more of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interntional Iindes of Erectile Function (IIEF) Score: Overall Satisfaction | Day 0-42 | The 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. |
| Post-void Residual Urine Volume | Day 0-42 | The 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. |
| International Prostate Specific Symptom (IPSS) Score | Day 0-42 | The 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). |
| IPSS Global Quality of Life | Day 0-42 | Patients 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. |
| Time of Minimal Value of Testosterone (Tnadir) | Day 0-42 | The time point when the lowest testosterone concentration was measured |
| Minimal Value of Testosterone (Cnadir) | Day 0-42 | The lowest concentration of testosterone measured within the time frame |
| Testosterone Area Below Baseline Interval | 0-42 Days | 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) |
| Time of Testosterone Concentration Below Baseline Interval | Day 0-42 | The 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 |
| Duration of Testosterone Concentration Below 0.5 ng/mL | Day 0-42 | The time from when the testosterone concentration falls below 0.5 ng/mL until it returns above that level |
| Number of Subjects With Testosterone Concentration ≤0.5 ng/mL | Day 0-42 | — |
| Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration | Day 0-42 | The baseline interval concentration is 0.75 x baseline concentration |
| Prostate Specific Antigen (PSA) Concentration | Day 0-42 | — |
| Prostate Volume | Day 0-42 | The 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. |
| Maximal Urinary Flow | Day 0-42 | Urinary flow was determined by flowmetry using a device that fulfils the International Continence Society standards for maximum urinary flow. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic Parameters of Degarelix: AUCt | 0-42 Days | Area under the time-concentration curve (AUCt) was calculated by non-compartmental methods based on data up to Day 42 |
| Pharmacokinetic Parameters of Degarelix: Cmax | Day 0-42 | Cmax was determined for concentration measurements up to Day 42 |
| Pharmacokinetic Parameters of Degarelix: Tmax | Day 0-42 | The time for maximal concentration (tmax) was determined for data up to Day 42 |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Degarelix 16+16 mg Two doses of Degarelix 16 mg on Day 0 and Day 14 | 13 |
| Degarelix 32 mg A single dose of Degarelix 32 mg on Day 0 | 13 |
| Degarelix 32+32 mg Two doses of Degarelix 32 mg on Day 0 and Day 14 | 13 |
| Degarelix 64 mg A single dose of Degarelix 64 mg on Day 0 | 13 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawn prior to dosing | 0 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Degarelix 16+16 mg | Degarelix 32 mg | Degarelix 32+32 mg | Degarelix 64 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 65.7 years STANDARD_DEVIATION 4.7 | 63.0 years STANDARD_DEVIATION 6.1 | 66.3 years STANDARD_DEVIATION 4.6 | 60.4 years STANDARD_DEVIATION 7.8 | 63.8 years STANDARD_DEVIATION 6.2 |
| Region of Enrollment Germany | 13 participants | 13 participants | 13 participants | 13 participants | 52 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 13 Participants | 13 Participants | 13 Participants | 13 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 13 | 11 / 12 | 12 / 12 | 13 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 12 | 1 / 12 | 1 / 13 |
Outcome results
Primary
Duration of Testosterone Concentration Below 0.5 ng/mL
The time from when the testosterone concentration falls below 0.5 ng/mL until it returns above that level
Time frame: Day 0-42
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Degarelix 16+16 mg | Duration of Testosterone Concentration Below 0.5 ng/mL | 0.0 Days |
| Degarelix 32 mg | Duration of Testosterone Concentration Below 0.5 ng/mL | 0.0 Days |
| Degarelix 32+32 mg | Duration of Testosterone Concentration Below 0.5 ng/mL | 1.4 Days |
| Degarelix 64 mg | Duration of Testosterone Concentration Below 0.5 ng/mL | 2.0 Days |
Primary
International Prostate Specific Symptom (IPSS) Score
The 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).
Time frame: Day 0-42
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Degarelix 16+16 mg | International Prostate Specific Symptom (IPSS) Score | Baseline | 17.7 Units on a scale | Standard Deviation 4.5 |
| Degarelix 16+16 mg | International Prostate Specific Symptom (IPSS) Score | Day 42 | 11.6 Units on a scale | Standard Deviation 4.5 |
| Degarelix 32 mg | International Prostate Specific Symptom (IPSS) Score | Day 42 | 9.1 Units on a scale | Standard Deviation 6.2 |
| Degarelix 32 mg | International Prostate Specific Symptom (IPSS) Score | Baseline | 22.3 Units on a scale | Standard Deviation 6.5 |
| Degarelix 32+32 mg | International Prostate Specific Symptom (IPSS) Score | Baseline | 18.2 Units on a scale | Standard Deviation 5.4 |
| Degarelix 32+32 mg | International Prostate Specific Symptom (IPSS) Score | Day 42 | 8.6 Units on a scale | Standard Deviation 5.7 |
| Degarelix 64 mg | International Prostate Specific Symptom (IPSS) Score | Baseline | 21.8 Units on a scale | Standard Deviation 6.2 |
| Degarelix 64 mg | International Prostate Specific Symptom (IPSS) Score | Day 42 | 11.8 Units on a scale | Standard Deviation 5.9 |
Primary
Interntional Iindes of Erectile Function (IIEF) Score: Overall Satisfaction
The 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.
Time frame: Day 0-42
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Degarelix 16+16 mg | Interntional Iindes of Erectile Function (IIEF) Score: Overall Satisfaction | Baseline | 6.6 Units on a scale | Standard Deviation 1.8 |
| Degarelix 16+16 mg | Interntional Iindes of Erectile Function (IIEF) Score: Overall Satisfaction | Day 42 | 6.8 Units on a scale | Standard Deviation 1.8 |
| Degarelix 32 mg | Interntional Iindes of Erectile Function (IIEF) Score: Overall Satisfaction | Day 42 | 6.2 Units on a scale | Standard Deviation 3.2 |
| Degarelix 32 mg | Interntional Iindes of Erectile Function (IIEF) Score: Overall Satisfaction | Baseline | 6.5 Units on a scale | Standard Deviation 2.5 |
| Degarelix 32+32 mg | Interntional Iindes of Erectile Function (IIEF) Score: Overall Satisfaction | Baseline | 5.8 Units on a scale | Standard Deviation 2.6 |
| Degarelix 32+32 mg | Interntional Iindes of Erectile Function (IIEF) Score: Overall Satisfaction | Day 42 | 6.0 Units on a scale | Standard Deviation 3 |
| Degarelix 64 mg | Interntional Iindes of Erectile Function (IIEF) Score: Overall Satisfaction | Baseline | 5.9 Units on a scale | Standard Deviation 2.8 |
| Degarelix 64 mg | Interntional Iindes of Erectile Function (IIEF) Score: Overall Satisfaction | Day 42 | 5.1 Units on a scale | Standard Deviation 2.3 |
Primary
IPSS Global Quality of Life
Patients 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.
Time frame: Day 0-42
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Degarelix 16+16 mg | IPSS Global Quality of Life | Baseline | 4.2 Units on a scale | Standard Deviation 1.1 |
| Degarelix 16+16 mg | IPSS Global Quality of Life | Day 42 | 2.9 Units on a scale | Standard Deviation 1.4 |
| Degarelix 32 mg | IPSS Global Quality of Life | Day 42 | 1.8 Units on a scale | Standard Deviation 2 |
| Degarelix 32 mg | IPSS Global Quality of Life | Baseline | 3.8 Units on a scale | Standard Deviation 1.7 |
| Degarelix 32+32 mg | IPSS Global Quality of Life | Baseline | 4.3 Units on a scale | Standard Deviation 1.3 |
| Degarelix 32+32 mg | IPSS Global Quality of Life | Day 42 | 1.9 Units on a scale | Standard Deviation 1.6 |
| Degarelix 64 mg | IPSS Global Quality of Life | Baseline | 4.7 Units on a scale | Standard Deviation 1.4 |
| Degarelix 64 mg | IPSS Global Quality of Life | Day 42 | 2.5 Units on a scale | Standard Deviation 1.3 |
Primary
Maximal Urinary Flow
Urinary flow was determined by flowmetry using a device that fulfils the International Continence Society standards for maximum urinary flow.
Time frame: Day 0-42
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Degarelix 16+16 mg | Maximal Urinary Flow | Baseline | 10.0 mL/s | Standard Deviation 4.7 |
| Degarelix 16+16 mg | Maximal Urinary Flow | Day 42 | 10.1 mL/s | Standard Deviation 4.3 |
| Degarelix 32 mg | Maximal Urinary Flow | Day 42 | 11.2 mL/s | Standard Deviation 4 |
| Degarelix 32 mg | Maximal Urinary Flow | Baseline | 11.7 mL/s | Standard Deviation 3.4 |
| Degarelix 32+32 mg | Maximal Urinary Flow | Baseline | 9.7 mL/s | Standard Deviation 4.1 |
| Degarelix 32+32 mg | Maximal Urinary Flow | Day 42 | 12.2 mL/s | Standard Deviation 9.3 |
| Degarelix 64 mg | Maximal Urinary Flow | Baseline | 9.1 mL/s | Standard Deviation 3 |
| Degarelix 64 mg | Maximal Urinary Flow | Day 42 | 11.9 mL/s | Standard Deviation 9.1 |
Primary
Minimal Value of Testosterone (Cnadir)
The lowest concentration of testosterone measured within the time frame
Time frame: Day 0-42
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Degarelix 16+16 mg | Minimal Value of Testosterone (Cnadir) | 1.4 ng/mL | Standard Deviation 0.5 |
| Degarelix 32 mg | Minimal Value of Testosterone (Cnadir) | 0.9 ng/mL | Standard Deviation 0.5 |
| Degarelix 32+32 mg | Minimal Value of Testosterone (Cnadir) | 0.4 ng/mL | Standard Deviation 0.3 |
| Degarelix 64 mg | Minimal Value of Testosterone (Cnadir) | 0.4 ng/mL | Standard Deviation 0.2 |
Primary
Number of Subjects With Testosterone Concentration ≤0.5 ng/mL
Time frame: Day 0-42
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 16+16 mg | Number of Subjects With Testosterone Concentration ≤0.5 ng/mL | Day 5 | 0 participants |
| Degarelix 16+16 mg | Number of Subjects With Testosterone Concentration ≤0.5 ng/mL | Day 42 | 0 participants |
| Degarelix 16+16 mg | Number of Subjects With Testosterone Concentration ≤0.5 ng/mL | Day 14 | 0 participants |
| Degarelix 16+16 mg | Number of Subjects With Testosterone Concentration ≤0.5 ng/mL | Day 28 | 0 participants |
| Degarelix 16+16 mg | Number of Subjects With Testosterone Concentration ≤0.5 ng/mL | Day 1 | 0 participants |
| Degarelix 16+16 mg | Number of Subjects With Testosterone Concentration ≤0.5 ng/mL | Day 17 | 0 participants |
| Degarelix 32 mg | Number of Subjects With Testosterone Concentration ≤0.5 ng/mL | Day 28 | 0 participants |
| Degarelix 32 mg | Number of Subjects With Testosterone Concentration ≤0.5 ng/mL | Day 17 | 0 participants |
| Degarelix 32 mg | Number of Subjects With Testosterone Concentration ≤0.5 ng/mL | Day 1 | 2 participants |
| Degarelix 32 mg | Number of Subjects With Testosterone Concentration ≤0.5 ng/mL | Day 5 | 0 participants |
| Degarelix 32 mg | Number of Subjects With Testosterone Concentration ≤0.5 ng/mL | Day 42 | 0 participants |
| Degarelix 32 mg | Number of Subjects With Testosterone Concentration ≤0.5 ng/mL | Day 14 | 0 participants |
| Degarelix 32+32 mg | Number of Subjects With Testosterone Concentration ≤0.5 ng/mL | Day 1 | 5 participants |
| Degarelix 32+32 mg | Number of Subjects With Testosterone Concentration ≤0.5 ng/mL | Day 5 | 1 participants |
| Degarelix 32+32 mg | Number of Subjects With Testosterone Concentration ≤0.5 ng/mL | Day 14 | 1 participants |
| Degarelix 32+32 mg | Number of Subjects With Testosterone Concentration ≤0.5 ng/mL | Day 17 | 8 participants |
| Degarelix 32+32 mg | Number of Subjects With Testosterone Concentration ≤0.5 ng/mL | Day 28 | 3 participants |
| Degarelix 32+32 mg | Number of Subjects With Testosterone Concentration ≤0.5 ng/mL | Day 42 | 3 participants |
| Degarelix 64 mg | Number of Subjects With Testosterone Concentration ≤0.5 ng/mL | Day 42 | 5 participants |
| Degarelix 64 mg | Number of Subjects With Testosterone Concentration ≤0.5 ng/mL | Day 28 | 5 participants |
| Degarelix 64 mg | Number of Subjects With Testosterone Concentration ≤0.5 ng/mL | Day 5 | 2 participants |
| Degarelix 64 mg | Number of Subjects With Testosterone Concentration ≤0.5 ng/mL | Day 1 | 8 participants |
| Degarelix 64 mg | Number of Subjects With Testosterone Concentration ≤0.5 ng/mL | Day 17 | 5 participants |
| Degarelix 64 mg | Number of Subjects With Testosterone Concentration ≤0.5 ng/mL | Day 14 | 5 participants |
Primary
Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration
The baseline interval concentration is 0.75 x baseline concentration
Time frame: Day 0-42
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 16+16 mg | Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration | Day 28 | 8 participants |
| Degarelix 16+16 mg | Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration | Day 42 | 8 participants |
| Degarelix 16+16 mg | Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration | Day14 | 11 participants |
| Degarelix 16+16 mg | Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration | Day 1 | 0 participants |
| Degarelix 32 mg | Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration | Day14 | 10 participants |
| Degarelix 32 mg | Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration | Day 28 | 9 participants |
| Degarelix 32 mg | Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration | Day 1 | 0 participants |
| Degarelix 32 mg | Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration | Day 42 | 12 participants |
| Degarelix 32+32 mg | Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration | Day14 | 7 participants |
| Degarelix 32+32 mg | Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration | Day 1 | 0 participants |
| Degarelix 32+32 mg | Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration | Day 42 | 3 participants |
| Degarelix 32+32 mg | Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration | Day 28 | 3 participants |
| Degarelix 64 mg | Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration | Day 42 | 4 participants |
| Degarelix 64 mg | Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration | Day 28 | 3 participants |
| Degarelix 64 mg | Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration | Day 1 | 0 participants |
| Degarelix 64 mg | Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration | Day14 | 2 participants |
Primary
Post-void Residual Urine Volume
The 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.
Time frame: Day 0-42
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Degarelix 16+16 mg | Post-void Residual Urine Volume | Baseline | 63.4 mL |
| Degarelix 16+16 mg | Post-void Residual Urine Volume | Day 42 | 58.0 mL |
| Degarelix 32 mg | Post-void Residual Urine Volume | Day 42 | 45.2 mL |
| Degarelix 32 mg | Post-void Residual Urine Volume | Baseline | 60.7 mL |
| Degarelix 32+32 mg | Post-void Residual Urine Volume | Baseline | 56.7 mL |
| Degarelix 32+32 mg | Post-void Residual Urine Volume | Day 42 | 34.6 mL |
| Degarelix 64 mg | Post-void Residual Urine Volume | Baseline | 91.3 mL |
| Degarelix 64 mg | Post-void Residual Urine Volume | Day 42 | 75.8 mL |
Primary
Prostate Specific Antigen (PSA) Concentration
Time frame: Day 0-42
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Degarelix 16+16 mg | Prostate Specific Antigen (PSA) Concentration | Baseline | 3.9 ng/mL | Standard Deviation 3.2 |
| Degarelix 16+16 mg | Prostate Specific Antigen (PSA) Concentration | Day 42 | 3.7 ng/mL | Standard Deviation 2.5 |
| Degarelix 32 mg | Prostate Specific Antigen (PSA) Concentration | Day 42 | 2.5 ng/mL | Standard Deviation 1.7 |
| Degarelix 32 mg | Prostate Specific Antigen (PSA) Concentration | Baseline | 3.0 ng/mL | Standard Deviation 2.6 |
| Degarelix 32+32 mg | Prostate Specific Antigen (PSA) Concentration | Baseline | 2.8 ng/mL | Standard Deviation 2.5 |
| Degarelix 32+32 mg | Prostate Specific Antigen (PSA) Concentration | Day 42 | 2.4 ng/mL | Standard Deviation 2.6 |
| Degarelix 64 mg | Prostate Specific Antigen (PSA) Concentration | Baseline | 3.2 ng/mL | Standard Deviation 3.1 |
| Degarelix 64 mg | Prostate Specific Antigen (PSA) Concentration | Day 42 | 2.3 ng/mL | Standard Deviation 1.9 |
Primary
Prostate Volume
The 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.
Time frame: Day 0-42
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Degarelix 16+16 mg | Prostate Volume | Baseline | 42.0 mL | Standard Deviation 12.1 |
| Degarelix 16+16 mg | Prostate Volume | Day 42 | 34.5 mL | Standard Deviation 11 |
| Degarelix 32 mg | Prostate Volume | Day 42 | 34.8 mL | Standard Deviation 14.2 |
| Degarelix 32 mg | Prostate Volume | Baseline | 48.7 mL | Standard Deviation 21 |
| Degarelix 32+32 mg | Prostate Volume | Baseline | 38.1 mL | Standard Deviation 7.1 |
| Degarelix 32+32 mg | Prostate Volume | Day 42 | 28.7 mL | Standard Deviation 8.2 |
| Degarelix 64 mg | Prostate Volume | Baseline | 38.9 mL | Standard Deviation 9 |
| Degarelix 64 mg | Prostate Volume | Day 42 | 30.6 mL | Standard Deviation 10.5 |
Primary
Testosterone Area Below Baseline Interval
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)
Time frame: 0-42 Days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Degarelix 16+16 mg | Testosterone Area Below Baseline Interval | 21.0 ng*days/mL | Standard Deviation 19.1 |
| Degarelix 32 mg | Testosterone Area Below Baseline Interval | 16.0 ng*days/mL | Standard Deviation 11.6 |
| Degarelix 32+32 mg | Testosterone Area Below Baseline Interval | 54.6 ng*days/mL | Standard Deviation 25.7 |
| Degarelix 64 mg | Testosterone Area Below Baseline Interval | 70.6 ng*days/mL | Standard Deviation 53.9 |
Primary
Time of Minimal Value of Testosterone (Tnadir)
The time point when the lowest testosterone concentration was measured
Time frame: Day 0-42
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Degarelix 16+16 mg | Time of Minimal Value of Testosterone (Tnadir) | 1.1 Days | Standard Deviation 0.6 |
| Degarelix 32 mg | Time of Minimal Value of Testosterone (Tnadir) | 1.3 Days | Standard Deviation 0.8 |
| Degarelix 32+32 mg | Time of Minimal Value of Testosterone (Tnadir) | 4.3 Days | Standard Deviation 5.3 |
| Degarelix 64 mg | Time of Minimal Value of Testosterone (Tnadir) | 8.8 Days | Standard Deviation 9.9 |
Primary
Time of Testosterone Concentration Below Baseline Interval
The 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
Time frame: Day 0-42
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Degarelix 16+16 mg | Time of Testosterone Concentration Below Baseline Interval | 21.2 Days | Standard Deviation 12.8 |
| Degarelix 32 mg | Time of Testosterone Concentration Below Baseline Interval | 13.2 Days | Standard Deviation 9.3 |
| Degarelix 32+32 mg | Time of Testosterone Concentration Below Baseline Interval | 34.3 Days | Standard Deviation 10.8 |
| Degarelix 64 mg | Time of Testosterone Concentration Below Baseline Interval | 34.0 Days | Standard Deviation 11.7 |
Secondary
Pharmacokinetic Parameters of Degarelix: AUCt
Area under the time-concentration curve (AUCt) was calculated by non-compartmental methods based on data up to Day 42
Time frame: 0-42 Days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Degarelix 16+16 mg | Pharmacokinetic Parameters of Degarelix: AUCt | 70.7 ng*day/mL | Standard Deviation 20.6 |
| Degarelix 32 mg | Pharmacokinetic Parameters of Degarelix: AUCt | 86.9 ng*day/mL | Standard Deviation 26.9 |
| Degarelix 32+32 mg | Pharmacokinetic Parameters of Degarelix: AUCt | 158 ng*day/mL | Standard Deviation 43.7 |
| Degarelix 64 mg | Pharmacokinetic Parameters of Degarelix: AUCt | 176 ng*day/mL | Standard Deviation 47.2 |
Secondary
Pharmacokinetic Parameters of Degarelix: Cmax
Cmax was determined for concentration measurements up to Day 42
Time frame: Day 0-42
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Degarelix 16+16 mg | Pharmacokinetic Parameters of Degarelix: Cmax | 4.5 ng/mL | Standard Deviation 1.2 |
| Degarelix 32 mg | Pharmacokinetic Parameters of Degarelix: Cmax | 6.9 ng/mL | Standard Deviation 1.9 |
| Degarelix 32+32 mg | Pharmacokinetic Parameters of Degarelix: Cmax | 9.6 ng/mL | Standard Deviation 3 |
| Degarelix 64 mg | Pharmacokinetic Parameters of Degarelix: Cmax | 15.8 ng/mL | Standard Deviation 4.6 |
Secondary
Pharmacokinetic Parameters of Degarelix: Tmax
The time for maximal concentration (tmax) was determined for data up to Day 42
Time frame: Day 0-42
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Degarelix 16+16 mg | Pharmacokinetic Parameters of Degarelix: Tmax | 1.0 Days | Standard Deviation 0 |
| Degarelix 32 mg | Pharmacokinetic Parameters of Degarelix: Tmax | 1.3 Days | Standard Deviation 0.8 |
| Degarelix 32+32 mg | Pharmacokinetic Parameters of Degarelix: Tmax | 1.1 Days | Standard Deviation 0.6 |
| Degarelix 64 mg | Pharmacokinetic Parameters of Degarelix: Tmax | 1.1 Days | Standard Deviation 0.6 |