Back to resultsExplorative Study of Degarelix for Treatment of Benign Prostatic Hyperplasia.
Primary Purpose
BPH
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Degarelix
Degarelix
Degarelix
Degarelix
Sponsored by
About this trial
This is an interventional treatment trial for BPH focused on measuring Benign Prostate Hyperplasia, BPH, PK/PD, GnRH antagonist
Eligibility Criteria
Inclusion Criteria:
Each patient must comply with all of the following inclusion criteria to be allowed to be randomised into the study:
- Man, 55 to 75 years of age.
- 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.
- 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.
- Has a baseline testosterone level above 3 ng/mL at screening.
Exclusion Criteria:
Any patient meeting one or more of the following exclusion criteria will not be included into the study:
- Previous surgery of the prostate.
- Previous treatment with GnRH agonists or GnRH antagonists.
- Treatment with 5-alpha reductase inhibitors, e.g., finasteride (Prosca®)or dutasteride (Avodart®) within the past 12 months before the study.
- Treatment with alpha-adrenergic antagonists, e.g., terazosin, doxazosin, tamsulosin, alfuzosin within 2 weeks prior to Screening part II (or Part I, if IPSS is performed at Screening part I).
- Treatment with any drug modifying the testosterone level or function within 12 weeks before Screening visit part II (or Part I, if IPSS is performed at Screening part I).
Sites / Locations
- CRS Clinical Research Services Monchengladback GmbH
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Degarelix 16+16 mg
Degarelix 32 mg
Degarelix 32+32 mg
Degarelix 64 mg
Arm Description
Outcomes
Primary Outcome Measures
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 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
Minimal Value of Testosterone (Cnadir)
The lowest concentration of testosterone measured within the time frame
Time of Minimal Value of Testosterone (Tnadir)
The time point when the lowest testosterone concentration was measured
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
Number of Subjects With Testosterone Concentration ≤0.5 ng/mL
Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration
The baseline interval concentration is 0.75 x baseline concentration
Prostate Specific Antigen (PSA) Concentration
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.
Maximal Urinary Flow
Urinary flow was determined by flowmetry using a device that fulfils the International Continence Society standards for maximum urinary flow.
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.
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).
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.
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.
Secondary Outcome Measures
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
Pharmacokinetic Parameters of Degarelix: Cmax
Cmax was determined for concentration measurements up to Day 42
Pharmacokinetic Parameters of Degarelix: Tmax
The time for maximal concentration (tmax) was determined for data up to Day 42
Full Information
NCT ID
NCT00527488
First Posted
September 10, 2007
Last Updated
April 14, 2015
Sponsor
Ferring Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00527488
Brief Title
Explorative Study of Degarelix for Treatment of Benign Prostatic Hyperplasia.
Official Title
A Single-centre, Open-label, Randomised Explorative Pharmacokinetic/Pharmacodynamic Study of the Gonadotropin-releasing Hormone Receptor Antagonist Degarelix (FE 200486) in Patients With Benign Prostatic Hyperplasia.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BPH
Keywords
Benign Prostate Hyperplasia, BPH, PK/PD, GnRH antagonist
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Degarelix 16+16 mg
Arm Type
Experimental
Arm Title
Degarelix 32 mg
Arm Type
Experimental
Arm Title
Degarelix 32+32 mg
Arm Type
Experimental
Arm Title
Degarelix 64 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Degarelix
Intervention Description
Two doses of 16 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days.
Intervention Type
Drug
Intervention Name(s)
Degarelix
Intervention Description
One dose of 32 mg administered as a single administration will be evaluated for 42 days.
Intervention Type
Drug
Intervention Name(s)
Degarelix
Intervention Description
Two doses of 32 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days.
Intervention Type
Drug
Intervention Name(s)
Degarelix
Intervention Description
One dose of 64 mg administered as a single administration will be evaluated for 42 days.
Primary Outcome Measure Information:
Title
Testosterone Area Below Baseline Interval
Description
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
Title
Time of Testosterone Concentration Below Baseline Interval
Description
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
Title
Minimal Value of Testosterone (Cnadir)
Description
The lowest concentration of testosterone measured within the time frame
Time Frame
Day 0-42
Title
Time of Minimal Value of Testosterone (Tnadir)
Description
The time point when the lowest testosterone concentration was measured
Time Frame
Day 0-42
Title
Duration of Testosterone Concentration Below 0.5 ng/mL
Description
The time from when the testosterone concentration falls below 0.5 ng/mL until it returns above that level
Time Frame
Day 0-42
Title
Number of Subjects With Testosterone Concentration ≤0.5 ng/mL
Time Frame
Day 0-42
Title
Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration
Description
The baseline interval concentration is 0.75 x baseline concentration
Time Frame
Day 0-42
Title
Prostate Specific Antigen (PSA) Concentration
Time Frame
Day 0-42
Title
Prostate Volume
Description
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
Title
Maximal Urinary Flow
Description
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
Title
Post-void Residual Urine Volume
Description
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
Title
International Prostate Specific Symptom (IPSS) Score
Description
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
Title
IPSS Global Quality of Life
Description
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
Title
Interntional Iindes of Erectile Function (IIEF) Score: Overall Satisfaction
Description
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
Secondary Outcome Measure Information:
Title
Pharmacokinetic Parameters of Degarelix: AUCt
Description
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
Title
Pharmacokinetic Parameters of Degarelix: Cmax
Description
Cmax was determined for concentration measurements up to Day 42
Time Frame
Day 0-42
Title
Pharmacokinetic Parameters of Degarelix: Tmax
Description
The time for maximal concentration (tmax) was determined for data up to Day 42
Time Frame
Day 0-42
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Each patient must comply with all of the following inclusion criteria to be allowed to be randomised into the study:
Man, 55 to 75 years of age.
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.
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.
Has a baseline testosterone level above 3 ng/mL at screening.
Exclusion Criteria:
Any patient meeting one or more of the following exclusion criteria will not be included into the study:
Previous surgery of the prostate.
Previous treatment with GnRH agonists or GnRH antagonists.
Treatment with 5-alpha reductase inhibitors, e.g., finasteride (Prosca®)or dutasteride (Avodart®) within the past 12 months before the study.
Treatment with alpha-adrenergic antagonists, e.g., terazosin, doxazosin, tamsulosin, alfuzosin within 2 weeks prior to Screening part II (or Part I, if IPSS is performed at Screening part I).
Treatment with any drug modifying the testosterone level or function within 12 weeks before Screening visit part II (or Part I, if IPSS is performed at Screening part I).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
CRS Clinical Research Services Monchengladback GmbH
City
Monchengladbach
ZIP/Postal Code
41061
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Explorative Study of Degarelix for Treatment of Benign Prostatic Hyperplasia.
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