Clinical trial NCT00947882: A Trial of Degarelix in Men With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lower Urinary Tract Symptoms (LUTS)
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-07-28
Enrollment: 404
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Mean Change in International Prostate Symptom Score (IPSS)
timeFrame: From Baseline to Month 3 after Dosing
Secondary outcomes:
measure: Mean Change in IPSS
timeFrame: From Baseline to Month 4, Month 5 and Month 6 after Dosing
measure: Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS
timeFrame: At Month 3, Month 4, Month 5 and Month 6 after Dosing
measure: Mean Percentage Change in Total Prostate Volume (TPV)
timeFrame: From Baseline to Month 3 and Month 6 after Dosing
measure: Mean Change in Maximum Urinary Flow (Qmax)
timeFrame: From Baseline to Month 3 and Month 6 after Dosing
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers of Alabama, PC
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research Inc
state: Alabama
city: Newport Beach
country: United States
facility: California Professional Research
state: California
city: Denver
country: United States
facility: Genitourinary Surgical Consultants
state: Colorado
city: Englewood
country: United States
facility: Urology Associates , PC
state: Colorado
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Orlando
country: United States
facility: Winter Park Urology Associates
state: Florida
city: St Petersburg
country: United States
facility: Pinellas Urology Inc
state: Florida
city: Tampa
country: United States
facility: Florida Urology Partners
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: New York
country: United States
facility: Weill Cornell Medical College New York Presbyterian
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Urology, PC
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Patient Priority Clinical Sites, LLC
state: Ohio
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Antwerpen
country: Belgium
facility: Middelheim Antwerp
city: Brussels
country: Belgium
facility: UZ Brussel
city: Victoria
country: Canada
facility: Can-Med Clinical Research Inc
state: British Columbia
city: Victoria
country: Canada
facility: Dr Steinhoff Clinical Research
state: British Columbia
city: Barrie
country: Canada
facility: Male/Female Health and Research Centre
state: Ontario
city: Brampton
country: Canada
facility: Bramalea Medical Centre
state: Ontario
city: Brantford
country: Canada
facility: Brandford Urology Research
state: Ontario
city: Guelph
country: Canada
facility: Guelp Urology
state: Ontario
city: Kingston
country: Canada
facility: Centre for Applied Urological Research
state: Ontario
city: North Bay
country: Canada
facility: Investigational Site
state: Ontario
city: Oakville
country: Canada
facility: Female/Male Health Centres
state: Ontario
city: Ottawa
country: Canada
facility: Mahoney Medicine Professional Corporation
state: Ontario
city: Owen Sound
country: Canada
facility: Todd Webster Ontario Inc
state: Ontario
city: Thunder Bay
country: Canada
facility: Anthony Skehan Medicine Professional Corporation
state: Ontario
city: Toronto
country: Canada
facility: The Male Health Centre
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Point-Claire
country: Canada
facility: Ultra-Med Inc
state: Quebec
city: Benesov
country: Czech Republic
facility: Urologie, Male namesti 1783
city: Brno
country: Czech Republic
facility: Urocentrum Brno, Purkynova 35e
city: Hradec Králové
country: Czech Republic
facility: Prvni privatni chirurgicke centrum SANUS, Labská kotlina I/1220
city: Litomerice
country: Czech Republic
facility: Urologicka ambulance, Litomerice (Halek)
city: Opava
country: Czech Republic
facility: Slezska nemocnice, prospevkova organizace, Urologicke oddeleni
city: Praha
country: Czech Republic
facility: Androgeos - soukrome urologicke a andrologicke cen, Na valech 4/289
city: Praha
country: Czech Republic
facility: Urocentrum, Karlovo namesti 3
city: Praha
country: Czech Republic
facility: Urologica ambulance, Praha 10
city: Ústi nad Labem
country: Czech Republic
facility: Ústecké urocentrum, Ústi nad Labem (Liehne)
city: Avellino
country: Italy
facility: Urologia, A.O. San Giuseppe Moscati, Avellino
city: Milano
country: Italy
facility: Unità Operativa di Urologia, Azienda Opsedaliera Luigi Sacco
city: Milano
country: Italy
facility: Unità Operativa di Urologia, Ospedale San Raffaele
city: Gdansk
country: Poland
facility: Akademia Medyczna w Gdansku
city: Inowroclaw
country: Poland
facility: Publiczny Specjalistyczny ZOZ
city: Zabrze
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr.1
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: