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) - CS36

Phase 1

Conditions: Bening Prostate Hyperplasia
MedDRA version: 12.0 Level: LLT Classification code 10014840 Term: Enlarged prostate (benign)

Registration Number: EUCTR2009-012325-11-GB

Lead Sponsor: Ferring Pharmaceuticals A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 380

Inclusion Criteria

1.Signed informed consent obtained before any trial-related activity is performed
2.Men, aged 50 or older
3.Clinical signs and symptoms of BPH for =6 months
4.Moderate to severe LUTS at screening, as defined by IPSS =13
5.An IPSS QoL score of =3 at screening
6.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)
7.Maximum urinary flow (Qmax) ranging between 5 to 15 mL/second with a minimum voided volume >125 mL at screening

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Post void residual volume (PVR) >250 mL
2.Stone in the bladder or urethra causing symptoms
3.Acute or chronic prostatitis
4.Interstitial cystitis / painful bladder syndrome
5.Acute or recurrent urinary tract infections
6.History of acute urinary retention (AUR)
7.Lower urinary tract instrumentation (including prostate biopsy) within 30 days of dosing at Visit 2
8.Clinical evidence of any of the following urinary tract conditions:
a) Mullerian duct cysts
b) Atonic, decompensated, or hypocontractile bladder
c) Detrusor-sphincter dyssynergia (contraction of the detrusor without sphincter relaxation)
9.History of any of the following pelvic conditions:
a) Pelvic surgery or any other pelvic procedure, including radical prostatectomy, pelvic surgery for removal of malignancy, or open lower colonic or rectal surgery
b) Pelvic radiotherapy
c) Any prior surgical procedure of the urinary tract, including minimally invasive LUTS/BPH therapies
d) Lower tract malignancy or trauma
10.Clinically significant microscopic hematuria at screening
11.History of significant renal insufficiency, defined as receiving renal dialysis or having an estimated creatinine clearance <30 mL/minute at screening
12.Systolic blood pressure >180 or <90 mmHg or diastolic blood pressure >110 or <50 mmHg at screening or malignant hypertension
13.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
14.Use of any prohibited therapies*
15.Elevated liver function tests at screening:
a) Aspartate aminotransferase (AST), alanine aminotranseferase (ALT), alkaline phosphatase (ALP) >2 times the upper limit of normal
b) Total bilirubin >1.5 times the upper limit of normal
16.QTc interval on the screening ECG >450 ms, or a family history of long QT syndrome
17.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
18.Diagnosed cancer within the last 5 years except for adequately managed basal cell carcinoma and squamous cell carcinoma of the skin
19.History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema
20.Mental incapacity or language barrier precluding adequate understanding or co-operation
21.History or current evidence of drug, alcohol, or substance abuse within 6 months prior to screening
22.Hypersensitivity towards any component of the investigational medicinal product (IMP)
23.Previous participation in any degarelix trial

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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