A Trial of Degarelix in Men With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)
Condition: Lower Urinary Tract Symptoms (LUTS)
MeSH terms: Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms
Intervention: Placebo; Degarelix 10 mg; Degarelix 20 mg; Degarelix 30 mg
Intervention description: Mannitol 50 mg/mL solution; 10 mg degarelix, 40 mg/mL solution; 20 mg degarelix, 40 mg/mL solution; 30 mg degarelix, 40 mg/mL solution
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 404.0
Sex: Male
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      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)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent obtained before any trial-related activity is performed

          -  Men, aged 50 or older

          -  Clinical signs and symptoms of BPH for ≥6 months

          -  Moderate to severe LUTS at screening, as defined by International Prostate Symptom
             Score (IPSS) ≥13

          -  An IPSS QoL score of ≥3 at screening

          -  Prostate specific antigen (PSA) at screening ≤10 ng/mL (responsibility of the
             Investigator to rule out prostate cancer when PSA is >4 ng/mL, except in the USA where
             patients with a PSA >4 and ≤10 ng/mL should undergo a prostatic biopsy or have a
             negative prostatic biopsy within 12 months prior to participation in the trial)

          -  Maximum urinary flow (Qmax) ranging between 5 to 15 mL/second with a minimum voided
             volume >125 mL at screening

        Exclusion Criteria:

          -  Post void residual volume (PVR) >250 mL

          -  Stone in the bladder or urethra causing symptoms

          -  Acute or chronic prostatitis

          -  Interstitial cystitis / painful bladder syndrome

          -  Acute or recurrent urinary tract infections

          -  History of acute urinary retention (AUR)

          -  Lower urinary tract instrumentation (including prostate biopsy) within 30 days of
             dosing at Visit 2

          -  Clinical evidence of any of the following urinary tract conditions:

               1. Mullerian duct cysts

               2. Atonic, decompensated, or hypocontractile bladder

               3. Detrusor-sphincter dyssynergia (contraction of the detrusor without sphincter
                  relaxation)

          -  History of any of the following pelvic conditions:

               1. Pelvic surgery or any other pelvic procedure, including radical prostatectomy,
                  pelvic surgery for removal of malignancy, or open lower colonic or rectal surgery

               2. Pelvic radiotherapy

               3. Any prior surgical procedure of the urinary tract, including minimally invasive
                  LUTS/BPH therapies

               4. Lower tract malignancy or trauma

          -  Clinically significant microscopic haematuria at screening

          -  History of significant renal insufficiency, defined as receiving renal dialysis or
             having an estimated creatinine clearance <30 mL/minute at screening

          -  Systolic blood pressure >180 or <90 mmHg or diastolic blood pressure >110 or <50 mmHg
             at screening or malignant hypertension

          -  Any causes other than BPH, which may affect evaluation of symptoms of urine flow (e.g.
             neurogenic bladder, bladder neck contracture, urethral stricture, and bladder
             malignancy) as judged by the Investigator

          -  Use of any prohibited therapies

          -  Elevated liver function tests at screening:

               1. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline
                  phosphatase (ALP) >2 times the upper limit of normal

               2. Total bilirubin >1.5 times the upper limit of normal

          -  QTc interval on the screening ECG >450 ms, or a family history of long QT syndrome

          -  Any clinically significant disorder (other than BPH) including, but not limited to,
             renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or
             psychiatric disease, or any other condition, which may affect the patient's health or
             the outcome of the trial as judged by the Investigator

          -  Diagnosed cancer within the last 5 years except for adequately managed basal cell
             carcinoma and squamous cell carcinoma of the skin

          -  History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or
             angioedema

          -  Mental incapacity or language barrier precluding adequate understanding or
             co-operation

          -  History or current evidence of drug, alcohol, or substance abuse within 6 months prior
             to screening

          -  Hypersensitivity towards any component of the investigational medicinal product (IMP)

          -  Previous participation in any degarelix trial