A Trial of Degarelix in Men With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)
NCT ID: NCT00947882
Last Updated: 2015-06-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
404 participants
INTERVENTIONAL
2009-08-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo
Mannitol 50 mg/mL solution
Degarelix 10 mg
Degarelix 10 mg
10 mg degarelix, 40 mg/mL solution
Degarelix 20 mg
Degarelix 20 mg
20 mg degarelix, 40 mg/mL solution
Degarelix 30 mg
Degarelix 30 mg
30 mg degarelix, 40 mg/mL solution
Interventions
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Placebo
Mannitol 50 mg/mL solution
Degarelix 10 mg
10 mg degarelix, 40 mg/mL solution
Degarelix 20 mg
20 mg degarelix, 40 mg/mL solution
Degarelix 30 mg
30 mg degarelix, 40 mg/mL solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
MALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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Urology Centers of Alabama, PC
Homewood, Alabama, United States
Coastal Clinical Research Inc
Mobile, Alabama, United States
California Professional Research
Newport Beach, California, United States
Genitourinary Surgical Consultants
Denver, Colorado, United States
Urology Associates , PC
Englewood, Colorado, United States
South Florida Medical Research
Aventura, Florida, United States
Winter Park Urology Associates
Orlando, Florida, United States
Pinellas Urology Inc
St. Petersburg, Florida, United States
Florida Urology Partners
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
Weill Cornell Medical College New York Presbyterian
New York, New York, United States
Hudson Valley Urology, PC
Poughkeepsie, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Patient Priority Clinical Sites, LLC
Cincinnati, Ohio, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Middelheim Antwerp
Antwerp, , Belgium
UZ Brussel
Brussels, , Belgium
Can-Med Clinical Research Inc
Victoria, British Columbia, Canada
Dr Steinhoff Clinical Research
Victoria, British Columbia, Canada
Male/Female Health and Research Centre
Barrie, Ontario, Canada
Bramalea Medical Centre
Brampton, Ontario, Canada
Brandford Urology Research
Brantford, Ontario, Canada
Guelp Urology
Guelph, Ontario, Canada
Centre for Applied Urological Research
Kingston, Ontario, Canada
Investigational Site
North Bay, Ontario, Canada
Female/Male Health Centres
Oakville, Ontario, Canada
Mahoney Medicine Professional Corporation
Ottawa, Ontario, Canada
Todd Webster Ontario Inc
Owen Sound, Ontario, Canada
Anthony Skehan Medicine Professional Corporation
Thunder Bay, Ontario, Canada
The Male Health Centre
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Ultra-Med Inc
Point-Claire, Quebec, Canada
Urologie, Male namesti 1783
Benešov, , Czechia
Urocentrum Brno, Purkynova 35e
Brno, , Czechia
Prvni privatni chirurgicke centrum SANUS, Labská kotlina I/1220
Hradec Králové, , Czechia
Urologicka ambulance, Litomerice (Halek)
Litoměřice, , Czechia
Slezska nemocnice, prospevkova organizace, Urologicke oddeleni
Opava, , Czechia
Androgeos - soukrome urologicke a andrologicke cen, Na valech 4/289
Prague, , Czechia
Urocentrum, Karlovo namesti 3
Prague, , Czechia
Urologica ambulance, Praha 10
Prague, , Czechia
Ústecké urocentrum, Ústi nad Labem (Liehne)
Ústi Nad Labem, , Czechia
Urologia, A.O. San Giuseppe Moscati, Avellino
Avellino, , Italy
Unità Operativa di Urologia, Azienda Opsedaliera Luigi Sacco
Milan, , Italy
Unità Operativa di Urologia, Ospedale San Raffaele
Milan, , Italy
Akademia Medyczna w Gdansku
Gdansk, , Poland
Publiczny Specjalistyczny ZOZ
Inowrocław, , Poland
Samodzielny Publiczny Szpital Kliniczny nr.1
Zabrze, , Poland
Countries
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Other Identifiers
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2009-012325-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
104367
Identifier Type: OTHER
Identifier Source: secondary_id
FE200486 CS36
Identifier Type: -
Identifier Source: org_study_id
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