A Trial of Degarelix in Men With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)

Phase 2

Completed

• Conditions: Lower Urinary Tract Symptoms (LUTS)
• Interventions: Drug: Degarelix 30 mg; Drug: Degarelix 10 mg; Drug: Placebo; Drug: Degarelix 20 mg

• Registration Number: NCT00947882
• Lead Sponsor: Ferring Pharmaceuticals

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-27
• Study First Submitted QC: 2009-07-27
• Study First Posted: 2009-07-28
• Study Start: 2009-08
• Primary Completion: 2011-03
• Study Completion: 2011-06
• Disposition First Submitted: 2012-03-09
• Disposition First Submitted QC: 2012-03-09
• Disposition First Posted: 2012-03-14
• Results First Submitted: 2014-04-22
• Results First Submitted QC: 2015-04-28
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-13
• Results First Posted: 2015-05-14
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 404

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Degarelix 30 mg	Degarelix 30 mg	-
Degarelix 10 mg	Degarelix 10 mg	-
Placebo	Placebo	-
Degarelix 20 mg	Degarelix 20 mg	-

Primary Outcome Measures

Name	Time	Method
Mean Change in International Prostate Symptom Score (IPSS)	From Baseline to Month 3 after Dosing	This outcome measure was used to assess the dose-response of the 3 degarelix dose groups in terms of severity of lower urinary tract symptoms (LUTS) and progress of the disease process, versus the placebo group. One treatment month equals 28 days.; The IPSS questionnaire is a tool commonly used to assess the severity of LUTS, and to monitor the progress of the symptoms during treatment. It contains 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5 (i.e. minimum total score is 0 and the maximum score is 35), where "0" corresponds to a response of "not at all" for the first six symptoms and "none" for nocturia, and "5" corresponds to a response of "almost always" for the first six symptoms and "5 times or more" for nocturia. The IPSS also includes a question to evaluate a patient's quality of life in relation to his urinary symptoms, which is not included in the total IPSS score.

Secondary Outcome Measures

Name	Time	Method
Mean Change in IPSS	From Baseline to Month 4, Month 5 and Month 6 after Dosing	This secondary outcome measure was used to assess the maintained dose-response of the 3 degarelix dose groups in terms of severity of LUTS and progress of the disease process, versus the placebo group.
Mean Change in Maximum Urinary Flow (Qmax)	From Baseline to Month 3 and Month 6 after Dosing	Urinary flow rate (mL/second) was measured using uroflowmetry performed according to the recommendation from the International Continence Society (ICS).
Mean Percentage Change in Total Prostate Volume (TPV)	From Baseline to Month 3 and Month 6 after Dosing	TPV was measured directly by standardised trans-rectal ultrasound (TRUS).
Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS	At Month 3, Month 4, Month 5 and Month 6 after Dosing	A 3-point reduction in IPSS score compared to baseline is defined as a clinically meaningful treatment response. Percentage of participants who met criteria for a clinically meaningful treatment response and odds ratios of treatment responses between each degarelix dose group and the placebo group are presented.

Trial Locations

Locations (47)

UZ Brussel; 🇧🇪 Brussels, Belgium

Dr Steinhoff Clinical Research; 🇨🇦 Victoria, British Columbia, Canada

Slezska nemocnice, prospevkova organizace, Urologicke oddeleni; 🇨🇿 Opava, Czech Republic

Androgeos - soukrome urologicke a andrologicke cen, Na valech 4/289; 🇨🇿 Praha, Czech Republic

Akademia Medyczna w Gdansku; 🇵🇱 Gdansk, Poland

Urologicka ambulance, Litomerice (Halek); 🇨🇿 Litomerice, Czech Republic

Middelheim Antwerp; 🇧🇪 Antwerpen, Belgium

Carolina Urologic Research Center; 🇺🇸 Myrtle Beach, South Carolina, United States

Samodzielny Publiczny Szpital Kliniczny nr.1; 🇵🇱 Zabrze, Poland

California Professional Research; 🇺🇸 Newport Beach, California, United States

Coastal Clinical Research Inc; 🇺🇸 Mobile, Alabama, United States

Urology Centers of Alabama, PC; 🇺🇸 Homewood, Alabama, 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

Florida Urology Partners; 🇺🇸 Tampa, Florida, United States

Hudson Valley Urology, PC; 🇺🇸 Poughkeepsie, New York, United States

Pinellas Urology Inc; 🇺🇸 St Petersburg, Florida, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Weill Cornell Medical College New York Presbyterian; 🇺🇸 New York, New York, United States

Patient Priority Clinical Sites, LLC; 🇺🇸 Cincinnati, Ohio, United States

Can-Med Clinical Research Inc; 🇨🇦 Victoria, British Columbia, Canada

Centre for Applied Urological Research; 🇨🇦 Kingston, Ontario, Canada

Brandford Urology Research; 🇨🇦 Brantford, Ontario, Canada

Male/Female Health and Research Centre; 🇨🇦 Barrie, Ontario, Canada

Guelp Urology; 🇨🇦 Guelph, Ontario, Canada

Bramalea Medical Centre; 🇨🇦 Brampton, Ontario, Canada

Investigational Site; 🇨🇦 North Bay, Ontario, Canada

Todd Webster Ontario Inc; 🇨🇦 Owen Sound, Ontario, Canada

Female/Male Health Centres; 🇨🇦 Oakville, Ontario, Canada

Anthony Skehan Medicine Professional Corporation; 🇨🇦 Thunder Bay, Ontario, Canada

Mahoney Medicine Professional Corporation; 🇨🇦 Ottawa, Ontario, Canada

The Male Health Centre; 🇨🇦 Toronto, Ontario, Canada

McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada

Ultra-Med Inc; 🇨🇦 Point-Claire, Quebec, Canada

Urocentrum Brno, Purkynova 35e; 🇨🇿 Brno, Czech Republic

Urologie, Male namesti 1783; 🇨🇿 Benesov, Czech Republic

Prvni privatni chirurgicke centrum SANUS, Labská kotlina I/1220; 🇨🇿 Hradec Králové, Czech Republic

Urocentrum, Karlovo namesti 3; 🇨🇿 Praha, Czech Republic

Urologica ambulance, Praha 10; 🇨🇿 Praha, Czech Republic

Urologia, A.O. San Giuseppe Moscati, Avellino; 🇮🇹 Avellino, Italy

Unità Operativa di Urologia, Azienda Opsedaliera Luigi Sacco; 🇮🇹 Milano, Italy

Unità Operativa di Urologia, Ospedale San Raffaele; 🇮🇹 Milano, Italy

Ústecké urocentrum, Ústi nad Labem (Liehne); 🇨🇿 Ústi nad Labem, Czech Republic

Publiczny Specjalistyczny ZOZ; 🇵🇱 Inowroclaw, Poland

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States