search
Back to results

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

Primary Purpose

Lower Urinary Tract Symptoms (LUTS)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Degarelix 10 mg
Degarelix 20 mg
Degarelix 30 mg
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Urinary Tract Symptoms (LUTS)

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Urology Centers of Alabama, PC
  • Coastal Clinical Research Inc
  • California Professional Research
  • Genitourinary Surgical Consultants
  • Urology Associates , PC
  • South Florida Medical Research
  • Winter Park Urology Associates
  • Pinellas Urology Inc
  • Florida Urology Partners
  • Northwestern University
  • Weill Cornell Medical College New York Presbyterian
  • Hudson Valley Urology, PC
  • Duke University Medical Center
  • Patient Priority Clinical Sites, LLC
  • Carolina Urologic Research Center
  • Middelheim Antwerp
  • UZ Brussel
  • Can-Med Clinical Research Inc
  • Dr Steinhoff Clinical Research
  • Male/Female Health and Research Centre
  • Bramalea Medical Centre
  • Brandford Urology Research
  • Guelp Urology
  • Centre for Applied Urological Research
  • Investigational Site
  • Female/Male Health Centres
  • Mahoney Medicine Professional Corporation
  • Todd Webster Ontario Inc
  • Anthony Skehan Medicine Professional Corporation
  • The Male Health Centre
  • McGill University Health Centre
  • Ultra-Med Inc
  • Urologie, Male namesti 1783
  • Urocentrum Brno, Purkynova 35e
  • Prvni privatni chirurgicke centrum SANUS, Labská kotlina I/1220
  • Urologicka ambulance, Litomerice (Halek)
  • Slezska nemocnice, prospevkova organizace, Urologicke oddeleni
  • Androgeos - soukrome urologicke a andrologicke cen, Na valech 4/289
  • Urocentrum, Karlovo namesti 3
  • Urologica ambulance, Praha 10
  • Ústecké urocentrum, Ústi nad Labem (Liehne)
  • Urologia, A.O. San Giuseppe Moscati, Avellino
  • Unità Operativa di Urologia, Azienda Opsedaliera Luigi Sacco
  • Unità Operativa di Urologia, Ospedale San Raffaele
  • Akademia Medyczna w Gdansku
  • Publiczny Specjalistyczny ZOZ
  • Samodzielny Publiczny Szpital Kliniczny nr.1

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

Degarelix 10 mg

Degarelix 20 mg

Degarelix 30 mg

Arm Description

Outcomes

Primary Outcome Measures

Mean Change in International Prostate Symptom Score (IPSS)
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

Mean Change in IPSS
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.
Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS
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.
Mean Percentage Change in Total Prostate Volume (TPV)
TPV was measured directly by standardised trans-rectal ultrasound (TRUS).
Mean Change in Maximum Urinary Flow (Qmax)
Urinary flow rate (mL/second) was measured using uroflowmetry performed according to the recommendation from the International Continence Society (ICS).

Full Information

First Posted
July 27, 2009
Last Updated
May 13, 2015
Sponsor
Ferring Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00947882
Brief Title
A Trial of Degarelix in Men With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)
Acronym
DELUTS
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

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms (LUTS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
404 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Degarelix 10 mg
Arm Type
Experimental
Arm Title
Degarelix 20 mg
Arm Type
Experimental
Arm Title
Degarelix 30 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Mannitol 50 mg/mL solution
Intervention Type
Drug
Intervention Name(s)
Degarelix 10 mg
Other Intervention Name(s)
FE200486, Firmagon
Intervention Description
10 mg degarelix, 40 mg/mL solution
Intervention Type
Drug
Intervention Name(s)
Degarelix 20 mg
Other Intervention Name(s)
FE200486, Firmagon
Intervention Description
20 mg degarelix, 40 mg/mL solution
Intervention Type
Drug
Intervention Name(s)
Degarelix 30 mg
Other Intervention Name(s)
FE200486, Firmagon
Intervention Description
30 mg degarelix, 40 mg/mL solution
Primary Outcome Measure Information:
Title
Mean Change in International Prostate Symptom Score (IPSS)
Description
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.
Time Frame
From Baseline to Month 3 after Dosing
Secondary Outcome Measure Information:
Title
Mean Change in IPSS
Description
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.
Time Frame
From Baseline to Month 4, Month 5 and Month 6 after Dosing
Title
Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS
Description
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.
Time Frame
At Month 3, Month 4, Month 5 and Month 6 after Dosing
Title
Mean Percentage Change in Total Prostate Volume (TPV)
Description
TPV was measured directly by standardised trans-rectal ultrasound (TRUS).
Time Frame
From Baseline to Month 3 and Month 6 after Dosing
Title
Mean Change in Maximum Urinary Flow (Qmax)
Description
Urinary flow rate (mL/second) was measured using uroflowmetry performed according to the recommendation from the International Continence Society (ICS).
Time Frame
From Baseline to Month 3 and Month 6 after Dosing

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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: Mullerian duct cysts Atonic, decompensated, or hypocontractile bladder Detrusor-sphincter dyssynergia (contraction of the detrusor without sphincter relaxation) History of any of the following pelvic conditions: Pelvic surgery or any other pelvic procedure, including radical prostatectomy, pelvic surgery for removal of malignancy, or open lower colonic or rectal surgery Pelvic radiotherapy Any prior surgical procedure of the urinary tract, including minimally invasive LUTS/BPH therapies 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: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) >2 times the upper limit of normal 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Urology Centers of Alabama, PC
City
Homewood
State/Province
Alabama
Country
United States
Facility Name
Coastal Clinical Research Inc
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
California Professional Research
City
Newport Beach
State/Province
California
Country
United States
Facility Name
Genitourinary Surgical Consultants
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Urology Associates , PC
City
Englewood
State/Province
Colorado
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
Country
United States
Facility Name
Winter Park Urology Associates
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Pinellas Urology Inc
City
St Petersburg
State/Province
Florida
Country
United States
Facility Name
Florida Urology Partners
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Weill Cornell Medical College New York Presbyterian
City
New York
State/Province
New York
Country
United States
Facility Name
Hudson Valley Urology, PC
City
Poughkeepsie
State/Province
New York
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Patient Priority Clinical Sites, LLC
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
Country
United States
Facility Name
Middelheim Antwerp
City
Antwerpen
Country
Belgium
Facility Name
UZ Brussel
City
Brussels
Country
Belgium
Facility Name
Can-Med Clinical Research Inc
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Dr Steinhoff Clinical Research
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Male/Female Health and Research Centre
City
Barrie
State/Province
Ontario
Country
Canada
Facility Name
Bramalea Medical Centre
City
Brampton
State/Province
Ontario
Country
Canada
Facility Name
Brandford Urology Research
City
Brantford
State/Province
Ontario
Country
Canada
Facility Name
Guelp Urology
City
Guelph
State/Province
Ontario
Country
Canada
Facility Name
Centre for Applied Urological Research
City
Kingston
State/Province
Ontario
Country
Canada
Facility Name
Investigational Site
City
North Bay
State/Province
Ontario
Country
Canada
Facility Name
Female/Male Health Centres
City
Oakville
State/Province
Ontario
Country
Canada
Facility Name
Mahoney Medicine Professional Corporation
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Todd Webster Ontario Inc
City
Owen Sound
State/Province
Ontario
Country
Canada
Facility Name
Anthony Skehan Medicine Professional Corporation
City
Thunder Bay
State/Province
Ontario
Country
Canada
Facility Name
The Male Health Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Ultra-Med Inc
City
Point-Claire
State/Province
Quebec
Country
Canada
Facility Name
Urologie, Male namesti 1783
City
Benesov
Country
Czech Republic
Facility Name
Urocentrum Brno, Purkynova 35e
City
Brno
Country
Czech Republic
Facility Name
Prvni privatni chirurgicke centrum SANUS, Labská kotlina I/1220
City
Hradec Králové
Country
Czech Republic
Facility Name
Urologicka ambulance, Litomerice (Halek)
City
Litomerice
Country
Czech Republic
Facility Name
Slezska nemocnice, prospevkova organizace, Urologicke oddeleni
City
Opava
Country
Czech Republic
Facility Name
Androgeos - soukrome urologicke a andrologicke cen, Na valech 4/289
City
Praha
Country
Czech Republic
Facility Name
Urocentrum, Karlovo namesti 3
City
Praha
Country
Czech Republic
Facility Name
Urologica ambulance, Praha 10
City
Praha
Country
Czech Republic
Facility Name
Ústecké urocentrum, Ústi nad Labem (Liehne)
City
Ústi nad Labem
Country
Czech Republic
Facility Name
Urologia, A.O. San Giuseppe Moscati, Avellino
City
Avellino
Country
Italy
Facility Name
Unità Operativa di Urologia, Azienda Opsedaliera Luigi Sacco
City
Milano
Country
Italy
Facility Name
Unità Operativa di Urologia, Ospedale San Raffaele
City
Milano
Country
Italy
Facility Name
Akademia Medyczna w Gdansku
City
Gdansk
Country
Poland
Facility Name
Publiczny Specjalistyczny ZOZ
City
Inowroclaw
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr.1
City
Zabrze
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs