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

May 13, 2015 updated by: Ferring Pharmaceuticals

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)

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
404

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium
        • Middelheim Antwerp
      • Brussels, Belgium
        • UZ Brussel
  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada
        • Can-Med Clinical Research Inc
      • Victoria, British Columbia, Canada
        • Dr Steinhoff Clinical Research
    • Ontario
      • Barrie, Ontario, Canada
        • Male/Female Health and Research Centre
      • Brampton, Ontario, Canada
        • Bramalea Medical Centre
      • Brantford, Ontario, Canada
        • Brandford Urology Research
      • Guelph, Ontario, Canada
        • Guelp Urology
      • Kingston, Ontario, Canada
        • Centre for Applied Urological Research
      • North Bay, Ontario, Canada
        • Investigational Site
      • Oakville, Ontario, Canada
        • Female/Male Health Centres
      • Ottawa, Ontario, Canada
        • Mahoney Medicine Professional Corporation
      • Owen Sound, Ontario, Canada
        • Todd Webster Ontario Inc
      • Thunder Bay, Ontario, Canada
        • Anthony Skehan Medicine Professional Corporation
      • Toronto, Ontario, Canada
        • The Male Health Centre
    • Quebec
      • Montreal, Quebec, Canada
        • McGill University Health Centre
      • Point-Claire, Quebec, Canada
        • Ultra-Med Inc
  • Czech Republic
      • Benesov, Czech Republic
        • Urologie, Male namesti 1783
      • Brno, Czech Republic
        • Urocentrum Brno, Purkynova 35e
      • Hradec Králové, Czech Republic
        • Prvni privatni chirurgicke centrum SANUS, Labská kotlina I/1220
      • Litomerice, Czech Republic
        • Urologicka ambulance, Litomerice (Halek)
      • Opava, Czech Republic
        • Slezska nemocnice, prospevkova organizace, Urologicke oddeleni
      • Praha, Czech Republic
        • Androgeos - soukrome urologicke a andrologicke cen, Na valech 4/289
      • Praha, Czech Republic
        • Urocentrum, Karlovo namesti 3
      • Praha, Czech Republic
        • Urologica ambulance, Praha 10
      • Ústi nad Labem, Czech Republic
        • Ústecké urocentrum, Ústi nad Labem (Liehne)
  • Italy
      • Avellino, Italy
        • Urologia, A.O. San Giuseppe Moscati, Avellino
      • Milano, Italy
        • Unità Operativa di Urologia, Azienda Opsedaliera Luigi Sacco
      • Milano, Italy
        • Unità Operativa di Urologia, Ospedale San Raffaele
  • Poland
      • Gdansk, Poland
        • Akademia Medyczna W Gdansku
      • Inowroclaw, Poland
        • Publiczny Specjalistyczny ZOZ
      • Zabrze, Poland
        • Samodzielny Publiczny Szpital Kliniczny nr.1
  • United States
    • Alabama
      • Homewood, Alabama, United States
        • Urology Centers of Alabama, PC
      • Mobile, Alabama, United States
        • Coastal Clinical Research Inc
    • California
      • Newport Beach, California, United States
        • California Professional Research
    • Colorado
      • Denver, Colorado, United States
        • Genitourinary Surgical Consultants
      • Englewood, Colorado, United States
        • Urology Associates , PC
    • Florida
      • Aventura, Florida, United States
        • South Florida Medical Research
      • Orlando, Florida, United States
        • Winter Park Urology Associates
      • St Petersburg, Florida, United States
        • Pinellas Urology Inc
      • Tampa, Florida, United States
        • Florida Urology Partners
    • Illinois
      • Chicago, Illinois, United States
        • Northwestern University
    • New York
      • New York, New York, United States
        • Weill Cornell Medical College New York Presbyterian
      • Poughkeepsie, New York, United States
        • Hudson Valley Urology, PC
    • North Carolina
      • Durham, North Carolina, United States
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States
        • Patient Priority Clinical Sites, LLC
    • South Carolina
      • Myrtle Beach, South Carolina, United States
        • Carolina Urologic Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Mannitol 50 mg/mL solution
Experimental: Degarelix 10 mg
Drug: Degarelix 10 mg
10 mg degarelix, 40 mg/mL solution
Other Names:
  • Firmagon
  • FE200486
Experimental: Degarelix 20 mg
Drug: Degarelix 20 mg
20 mg degarelix, 40 mg/mL solution
Other Names:
  • Firmagon
  • FE200486
Experimental: Degarelix 30 mg
Drug: Degarelix 30 mg
30 mg degarelix, 40 mg/mL solution
Other Names:
  • Firmagon
  • FE200486

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Change in International Prostate Symptom Score (IPSS)
Time Frame: 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.
From Baseline to Month 3 after Dosing

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Change in IPSS
Time Frame: 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.
From Baseline to Month 4, Month 5 and Month 6 after Dosing
Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS
Time Frame: 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.
At Month 3, Month 4, Month 5 and Month 6 after Dosing
Mean Percentage Change in Total Prostate Volume (TPV)
Time Frame: From Baseline to Month 3 and Month 6 after Dosing
TPV was measured directly by standardised trans-rectal ultrasound (TRUS).
From Baseline to Month 3 and Month 6 after Dosing
Mean Change in Maximum Urinary Flow (Qmax)
Time Frame: 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).
From Baseline to Month 3 and Month 6 after Dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FE200486 CS36
  • 2009-012325-11 (EudraCT Number)
  • 104367 (Other Identifier: IND Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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