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Lower Urinary Tract Symptoms (LUTS)Phase 2DELUTSNCT00947882

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

A Phase 2 study testing Degarelix 10 mg, Degarelix 20 mg and Degarelix 30 mg in people with Lower Urinary Tract Symptoms (LUTS), run by Ferring Pharmaceuticals at 47 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 50 years and older, men only
Conditions the study is for
Lower Urinary Tract Symptoms (LUTS)
What is being tested?
Degarelix 10 mg, Degarelix 20 mg and Degarelix 30 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
404 participants
Where
47 sitesin 6 countries
Study dates
Aug 2009to Jun 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 32Show fewer
  • 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

Trial locations and contacts

47 sites in 6 countries.

47 sites in 6 countries

United States15 sites

  • South Florida Medical Research

    Aventura, Florida

  • Northwestern University

    Chicago, Illinois

  • Patient Priority Clinical Sites, LLC

    Cincinnati, Ohio

  • Genitourinary Surgical Consultants

    Denver, Colorado

  • Duke University Medical Center

    Durham, North Carolina

  • Urology Associates , PC

    Englewood, Colorado

  • Urology Centers of Alabama, PC

    Homewood, Alabama

  • Coastal Clinical Research Inc

    Mobile, Alabama

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina

  • Weill Cornell Medical College New York Presbyterian

    New York, New York

  • California Professional Research

    Newport Beach, California

  • Winter Park Urology Associates

    Orlando, Florida

  • Hudson Valley Urology, PC

    Poughkeepsie, New York

  • Pinellas Urology Inc

    St. Petersburg, Florida

  • Florida Urology Partners

    Tampa, Florida

Other trials in United States

Canada15 sites

  • Male/Female Health and Research Centre

    Barrie, Ontario

  • Bramalea Medical Centre

    Brampton, Ontario

  • Brandford Urology Research

    Brantford, Ontario

  • Guelp Urology

    Guelph, Ontario

  • Centre for Applied Urological Research

    Kingston, Ontario

  • McGill University Health Centre

    Montreal, Quebec

  • Investigational Site

    North Bay, Ontario

  • Female/Male Health Centres

    Oakville, Ontario

  • Mahoney Medicine Professional Corporation

    Ottawa, Ontario

  • Todd Webster Ontario Inc

    Owen Sound, Ontario

  • Ultra-Med Inc

    Point-Claire, Quebec

  • Anthony Skehan Medicine Professional Corporation

    Thunder Bay, Ontario

  • The Male Health Centre

    Toronto, Ontario

  • Can-Med Clinical Research Inc

    Victoria, British Columbia

  • Dr Steinhoff Clinical Research

    Victoria, British Columbia

Other trials in Canada

Czechia9 sites

  • Urologie, Male namesti 1783

    Benešov

  • Urocentrum Brno, Purkynova 35e

    Brno

  • Prvni privatni chirurgicke centrum SANUS, Labská kotlina I/1220

    Hradec Králové

  • Urologicka ambulance, Litomerice (Halek)

    Litoměřice

  • Slezska nemocnice, prospevkova organizace, Urologicke oddeleni

    Opava

  • Androgeos - soukrome urologicke a andrologicke cen, Na valech 4/289

    Prague

  • Urocentrum, Karlovo namesti 3

    Prague

  • Urologica ambulance, Praha 10

    Prague

  • Ústecké urocentrum, Ústi nad Labem (Liehne)

    Ústi Nad Labem

Other trials in Czechia

Italy3 sites

  • Urologia, A.O. San Giuseppe Moscati, Avellino

    Avellino

  • Unità Operativa di Urologia, Azienda Opsedaliera Luigi Sacco

    Milan

  • Unità Operativa di Urologia, Ospedale San Raffaele

    Milan

Other trials in Italy

Poland3 sites

  • Akademia Medyczna w Gdansku

    Gdansk

  • Publiczny Specjalistyczny ZOZ

    Inowrocław

  • Samodzielny Publiczny Szpital Kliniczny nr.1

    Zabrze

Other trials in Poland

Belgium2 sites

  • Middelheim Antwerp

    Antwerp

  • UZ Brussel

    Brussels

Other trials in Belgium

About this study

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)

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)

Being tested
Placebo, Degarelix 10 mg, Degarelix 20 mg, Degarelix 30 mg
Medical subject headings
Lower Urinary Tract Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Mannitol 50 mg/mL solution

  • Degarelix 10 mgDrug

    Also called FE200486, Firmagon

    10 mg degarelix, 40 mg/mL solution

  • Degarelix 20 mgDrug

    Also called FE200486, Firmagon

    20 mg degarelix, 40 mg/mL solution

  • Degarelix 30 mgDrug

    Also called FE200486, Firmagon

    30 mg degarelix, 40 mg/mL solution

Study groups in NCT00947882
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
Degarelix 10 mgExperimentalNot described
Receives: Drug: Degarelix 10 mg
Degarelix 20 mgExperimentalNot described
Receives: Drug: Degarelix 20 mg
Degarelix 30 mgExperimentalNot described
Receives: Drug: Degarelix 30 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From Baseline to Month 3 after Dosing

Secondary outcomes (4)

  1. 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.

    Measured: From Baseline to Month 4, Month 5 and Month 6 after Dosing

  2. 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.

    Measured: At Month 3, Month 4, Month 5 and Month 6 after Dosing

  3. Mean Percentage Change in Total Prostate Volume (TPV)

    TPV was measured directly by standardised trans-rectal ultrasound (TRUS).

    Measured: From Baseline to Month 3 and Month 6 after Dosing

  4. 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).

    Measured: From Baseline to Month 3 and Month 6 after Dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionMar 2011
  4. Study completionJun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
404 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00947882
Sponsor's protocol ID
FE200486 CS36
Other IDs
2009-012325-11, 104367, 2009
Acronym
DELUTS
Status last verified
May 2015
First submitted
27 Jul 2009
Last updated
8 Jun 2015
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Degarelix 10 mg, Degarelix 20 mg and Degarelix 30 mg in people with Lower Urinary Tract Symptoms (LUTS), run by Ferring Pharmaceuticals at 47 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States, Canada, Czechia, Italy, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in International Prostate Symptom Score (IPSS) (time frame: From Baseline to Month 3 after Dosing). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00947882.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2015.

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