Explorative Study of Degarelix for Treatment of Benign Prostatic Hyperplasia.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00527488|
Recruitment Status : Completed
First Posted : September 11, 2007
Results First Posted : November 25, 2010
Last Update Posted : May 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|BPH||Drug: Degarelix||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||October 2007|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||May 2009|
|Experimental: Degarelix 16+16 mg||
Two doses of 16 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days.
|Experimental: Degarelix 32 mg||
One dose of 32 mg administered as a single administration will be evaluated for 42 days.
|Experimental: Degarelix 32+32 mg||
Two doses of 32 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days.
|Experimental: Degarelix 64 mg||
One dose of 64 mg administered as a single administration will be evaluated for 42 days.
- Testosterone Area Below Baseline Interval [ Time Frame: 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 [ Time Frame: 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
- Minimal Value of Testosterone (Cnadir) [ Time Frame: Day 0-42 ]The lowest concentration of testosterone measured within the time frame
- Time of Minimal Value of Testosterone (Tnadir) [ Time Frame: Day 0-42 ]The time point when the lowest testosterone concentration was measured
- Duration of Testosterone Concentration Below 0.5 ng/mL [ Time Frame: 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 [ Time Frame: Day 0-42 ]
- Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration [ Time Frame: Day 0-42 ]The baseline interval concentration is 0.75 x baseline concentration
- Prostate Specific Antigen (PSA) Concentration [ Time Frame: Day 0-42 ]
- Prostate Volume [ Time Frame: 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 [ Time Frame: Day 0-42 ]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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- Interntional Iindes of Erectile Function (IIEF) Score: Overall Satisfaction [ Time Frame: 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.
- Pharmacokinetic Parameters of Degarelix: AUCt [ Time Frame: 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 [ Time Frame: Day 0-42 ]Cmax was determined for concentration measurements up to Day 42
- Pharmacokinetic Parameters of Degarelix: Tmax [ Time Frame: Day 0-42 ]The time for maximal concentration (tmax) was determined for data up to Day 42
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00527488
|CRS Clinical Research Services Monchengladback GmbH|
|Monchengladbach, Germany, 41061|
|Study Director:||Clinical Development Support||Ferring Pharmaceuticals|