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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-003578-24 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Degarelix 16+16 mg | Experimental |
| |
| Degarelix 32 mg | Experimental |
| |
| Degarelix 32+32 mg | Experimental |
| |
| Degarelix 64 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Degarelix | Drug | Two doses of 16 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 0-42 Days |
| 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 | Day 0-42 |
| Minimal Value of Testosterone (Cnadir) | The lowest concentration of testosterone measured within the time frame | Day 0-42 |
| Time of Minimal Value of Testosterone (Tnadir) | The time point when the lowest testosterone concentration was measured | Day 0-42 |
| 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 | Day 0-42 |
| 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 | The baseline interval concentration is 0.75 x baseline concentration | Day 0-42 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 0-42 Days |
| Pharmacokinetic Parameters of Degarelix: Cmax |
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Inclusion Criteria:
Each patient must comply with all of the following inclusion criteria to be allowed to be randomised into the study:
Exclusion Criteria:
Any patient meeting one or more of the following exclusion criteria will not be included into the study:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Monchengladback GmbH | Mönchengladbach | 41061 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Degarelix 16+16 mg | Two doses of Degarelix 16 mg on Day 0 and Day 14 |
| FG001 | Degarelix 32 mg | A single dose of Degarelix 32 mg on Day 0 |
| FG002 | Degarelix 32+32 mg | Two doses of Degarelix 32 mg on Day 0 and Day 14 |
| FG003 | Degarelix 64 mg | A single dose of Degarelix 64 mg on Day 0 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Degarelix 16+16 mg | Two doses of Degarelix 16 mg on Day 0 and Day 14 |
| BG001 | Degarelix 32 mg | A single dose of Degarelix 32 mg on Day 0 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Mean | Standard Deviation | ng*days/mL | 0-42 Days |
|
Day 0-42
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Degarelix 16+16 mg | Two doses of Degarelix 16 mg on Day 0 and Day 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (11.0) | Systematic Assessment | Causality to degarelix regarded as unlikely by the investigator |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | DK0-Disclosure@ferring.com |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C431566 | acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide |
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| Degarelix | Drug | One dose of 32 mg administered as a single administration will be evaluated for 42 days. |
|
| Degarelix | Drug | Two doses of 32 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days. |
|
| Degarelix | Drug | One dose of 64 mg administered as a single administration will be evaluated for 42 days. |
|
| Prostate Specific Antigen (PSA) Concentration |
| Day 0-42 |
| 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. | Day 0-42 |
| Maximal Urinary Flow | Urinary flow was determined by flowmetry using a device that fulfils the International Continence Society standards for maximum urinary flow. | Day 0-42 |
| 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. | Day 0-42 |
| 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). | Day 0-42 |
| 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. | Day 0-42 |
| 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. | Day 0-42 |
Cmax was determined for concentration measurements up to Day 42
| Day 0-42 |
| Pharmacokinetic Parameters of Degarelix: Tmax | The time for maximal concentration (tmax) was determined for data up to Day 42 | Day 0-42 |
| BG002 | Degarelix 32+32 mg | Two doses of Degarelix 32 mg on Day 0 and Day 14 |
| BG003 | Degarelix 64 mg | A single dose of Degarelix 64 mg on Day 0 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Two doses of Degarelix 32 mg on Day 0 and Day 14
| OG003 | Degarelix 64 mg | A single dose of Degarelix 64 mg on Day 0 |
|
|
| 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 | Posted | Mean | Standard Deviation | ng*day/mL | 0-42 Days |
|
|
|
| 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 | Posted | Mean | Standard Deviation | Days | Day 0-42 |
|
|
|
| Primary | Minimal Value of Testosterone (Cnadir) | The lowest concentration of testosterone measured within the time frame | Posted | Mean | Standard Deviation | ng/mL | Day 0-42 |
|
|
|
| Primary | Time of Minimal Value of Testosterone (Tnadir) | The time point when the lowest testosterone concentration was measured | Posted | Mean | Standard Deviation | Days | Day 0-42 |
|
|
|
| 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 | Posted | Median | Full Range | Days | Day 0-42 |
|
|
|
| Primary | Number of Subjects With Testosterone Concentration ≤0.5 ng/mL | Posted | Number | participants | Day 0-42 |
|
|
|
| Primary | Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration | The baseline interval concentration is 0.75 x baseline concentration | Posted | Number | participants | Day 0-42 |
|
|
|
| Primary | Prostate Specific Antigen (PSA) Concentration | Posted | Mean | Standard Deviation | ng/mL | Day 0-42 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | mL | Day 0-42 |
|
|
|
| Primary | Maximal Urinary Flow | Urinary flow was determined by flowmetry using a device that fulfils the International Continence Society standards for maximum urinary flow. | Posted | Mean | Standard Deviation | mL/s | Day 0-42 |
|
|
|
| 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. | Posted | Mean | Full Range | mL | Day 0-42 |
|
|
|
| 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). | Posted | Mean | Standard Deviation | Units on a scale | Day 0-42 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Units on a scale | Day 0-42 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Units on a scale | Day 0-42 |
|
|
|
| Secondary | Pharmacokinetic Parameters of Degarelix: Cmax | Cmax was determined for concentration measurements up to Day 42 | Posted | Mean | Standard Deviation | ng/mL | Day 0-42 |
|
|
|
| Secondary | Pharmacokinetic Parameters of Degarelix: Tmax | The time for maximal concentration (tmax) was determined for data up to Day 42 | Posted | Mean | Standard Deviation | Days | Day 0-42 |
|
|
|
| 0 |
| 13 |
| 13 |
| 13 |
| EG001 | Degarelix 32 mg | A single dose of Degarelix 32 mg on Day 0 | 0 | 12 | 11 | 12 |
| EG002 | Degarelix 32+32 mg | Two doses of Degarelix 32 mg on Day 0 and Day 14 | 1 | 12 | 12 | 12 |
| EG003 | Degarelix 64 mg | A single dose of Degarelix 64 mg on Day 0 | 1 | 13 | 13 | 13 |
|
| Syncope | Nervous system disorders | MedDRA (11.0) | Systematic Assessment | Causality regarded as unlikely by the investigator |
|
| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Loss of libido | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
|
| Libido increased | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
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.
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