Efficacy and Safety of Degarelix in men with LUTS associated with BPH.

• Research type

  Research Study

• Full 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).

• IRAS ID

  27532

• Sponsor organisation

  Ferring Pharmaceutical A/C

• Eudract number

  2009-012325-11

• ISRCTN Number

  n/a

• Research summary

  Benign Prostatic Hyperplasia (BPH) is one of the most common diseases of middle-aged and elderly men. BPH causes the prostate to increase in size and if left untreated can result in decreased flow of urine and increased urinary retention and in some cases prostate surgery. This study is designed to investigate the effects of Degarelix on lower urinary tract symptoms (LUTS) associated with BPH using the IPSS questionnaire. Components of the IPSS questionnaire include urgency, frequency, intermittency, need to strain, weak flow, and incomplete emptying of the bladder. Eligible patients will be male, aged 50 years or older and will have had symptoms of BPH for at least 6 months. Their LUTS has to be of moderate to severe in intensity (IPSS >13). The study will compare three doses of Degarelix, 10mg, 20mg and 30mg against a placebo. Patients will receive a single injection of either one of these doses of Degarelix or a placebo. A screening period of up to 2-4 weeks will occur and following the injection of the drug patients will be followed up regularly for up to 1 year. Key exploratory analyses will include effects on total prostate volume measured by transrectal ultrasound and quality of life assessments (BPHII, IPSS QoL, EQ-5) and safety focusing on testosterone suppression related issues. A total of 380 patients will be included in the study from sites across Europe, US and Canada. Some subgroups of patients may have extra blood samples taken to evaluate levels of Degarelix in the blood and some patients will undergo a closer monitoring of bone markers and bone mineral density during the observation period. These sub-groups will be decided prior to trial initiation. Ultimate goal is to identify the optimal dose and the duration of the anticipated pharmacodynamic effect.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  09/H0405/47

• Date of REC Opinion

  22 Oct 2009

• REC opinion

  Further Information Favourable Opinion