A Trial of Degarelix in Men With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) (DELUTS)
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|ClinicalTrials.gov Identifier: NCT00947882|
Recruitment Status : Completed
First Posted : July 28, 2009
Results First Posted : May 14, 2015
Last Update Posted : June 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|Lower Urinary Tract Symptoms (LUTS)||Drug: Placebo Drug: Degarelix 10 mg Drug: Degarelix 20 mg Drug: Degarelix 30 mg||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||404 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Dose-Finding, Multi-Centre, Double-Blind, Randomised, Parallel, Placebo-Controlled Trial to Investigate Efficacy and Safety of Degarelix in Men With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||June 2011|
|Placebo Comparator: Placebo||
Mannitol 50 mg/mL solution
|Experimental: Degarelix 10 mg||
Drug: Degarelix 10 mg
10 mg degarelix, 40 mg/mL solution
|Experimental: Degarelix 20 mg||
Drug: Degarelix 20 mg
20 mg degarelix, 40 mg/mL solution
|Experimental: Degarelix 30 mg||
Drug: Degarelix 30 mg
30 mg degarelix, 40 mg/mL solution
- Mean Change in International Prostate Symptom Score (IPSS) [ Time Frame: From Baseline to Month 3 after Dosing ]
This outcome measure was used to assess the dose-response of the 3 degarelix dose groups in terms of severity of lower urinary tract symptoms (LUTS) and progress of the disease process, versus the placebo group. One treatment month equals 28 days.
The IPSS questionnaire is a tool commonly used to assess the severity of LUTS, and to monitor the progress of the symptoms during treatment. It contains 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5 (i.e. minimum total score is 0 and the maximum score is 35), where "0" corresponds to a response of "not at all" for the first six symptoms and "none" for nocturia, and "5" corresponds to a response of "almost always" for the first six symptoms and "5 times or more" for nocturia. The IPSS also includes a question to evaluate a patient's quality of life in relation to his urinary symptoms, which is not included in the total IPSS score.
- Mean Change in IPSS [ Time Frame: From Baseline to Month 4, Month 5 and Month 6 after Dosing ]This secondary outcome measure was used to assess the maintained dose-response of the 3 degarelix dose groups in terms of severity of LUTS and progress of the disease process, versus the placebo group.
- Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS [ Time Frame: At Month 3, Month 4, Month 5 and Month 6 after Dosing ]A 3-point reduction in IPSS score compared to baseline is defined as a clinically meaningful treatment response. Percentage of participants who met criteria for a clinically meaningful treatment response and odds ratios of treatment responses between each degarelix dose group and the placebo group are presented.
- Mean Percentage Change in Total Prostate Volume (TPV) [ Time Frame: From Baseline to Month 3 and Month 6 after Dosing ]TPV was measured directly by standardised trans-rectal ultrasound (TRUS).
- Mean Change in Maximum Urinary Flow (Qmax) [ Time Frame: From Baseline to Month 3 and Month 6 after Dosing ]Urinary flow rate (mL/second) was measured using uroflowmetry performed according to the recommendation from the International Continence Society (ICS).
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): NCT00947882
|Study Director:||Clinical Development Support||Ferring Pharmaceuticals|