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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00947882
First received: July 27, 2009
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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)


Condition Intervention Phase
Lower Urinary Tract Symptoms (LUTS)
Drug: Placebo
Drug: Degarelix 10 mg
Drug: Degarelix 20 mg
Drug: Degarelix 30 mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Mean Change in International Prostate Symptom Score (IPSS) [ Time Frame: From Baseline to Month 3 after Dosing ] [ Designated as safety issue: No ]

    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 8 questions, each one assigned a score of 0-5, 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 first 7 questions comprise the following symptoms: incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and 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 [ Time Frame: From Baseline to Month 4, Month 5 and Month 6 after Dosing ] [ Designated as safety issue: No ]
    This secondary outcome measure was used to assess the 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 of Treatment Response (as Compared to Placebo) in IPSS [ Time Frame: At Month 3, Month 4, Month 5 and Month 6 after Dosing ] [ Designated as safety issue: No ]
    A 3-point reduction in IPSS score compared to baseline is defined as a clinically meaningful treatment response. Odds ratios of treatment responses between each degarelix dose group and the placebo group are presented. (Adjustments are made for treatment group, baseline IPSS, graphical region and baseline prostate size.)

  • Change in Total Prostate Volume (TPV) [ Time Frame: From Baseline to Month 3 and Month 6 after Dosing ] [ Designated as safety issue: No ]
    TPV was measured directly by standardised trans-rectal ultrasound (TRUS). Changes are presented as percentages.

  • Mean Change in Maximum Urine Flow (Qmax) [ Time Frame: From Baseline to Month 3 and Month 6 after Dosing ] [ Designated as safety issue: No ]
    Urinary flow rate (mL/second) was measured using uroflowmetry performed according to the recommendation from the International Continence Society (ICS).


Enrollment: 404
Study Start Date: August 2009
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • FE200486
  • Firmagon
Experimental: Degarelix 20 mg Drug: Degarelix 20 mg
20 mg degarelix, 40 mg/mL solution
Other Names:
  • FE200486
  • Firmagon
Experimental: Degarelix 30 mg Drug: Degarelix 30 mg
30 mg degarelix, 40 mg/mL solution
Other Names:
  • FE200486
  • Firmagon

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 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 hematuria 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00947882

  Show 47 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00947882     History of Changes
Other Study ID Numbers: FE200486 CS36, 2009-012325-11
Study First Received: July 27, 2009
Last Updated: February 17, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Health Canada
Canada: Ethics Review Committee
Italy: The Italian Medicines Agency
Italy: Ministry of Health
Italy: National Bioethics Committee
Czech Republic: State Institute for Drug Control
Czech Republic: Ethics Committee
Poland: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
Denmark: Danish Medicines Agency
Denmark: The Danish National Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Hyperplasia
Lower Urinary Tract Symptoms
Prostatic Hyperplasia
Genital Diseases, Male
Pathologic Processes
Prostatic Diseases
Signs and Symptoms
Urological Manifestations

ClinicalTrials.gov processed this record on October 20, 2014