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

NCT00947882 | Completed Phase 2 Results DMC

• 3 other identifiers: FE200486 CS362009-012325-11104367
• Study Type: interventional
• Target: 404
• Locations: 6 countries
• Sites: 47

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)

Conditions

Lower Urinary Tract Symptoms (LUTS)

Outcome Measures

Primary Outcomes (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.

  From Baseline to Month 3 after Dosing

Secondary Outcomes (4)

• Mean Change in IPSS

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

• Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS

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

• Mean Percentage Change in Total Prostate Volume (TPV)

  From Baseline to Month 3 and Month 6 after Dosing

• Mean Change in Maximum Urinary Flow (Qmax)

  From Baseline to Month 3 and Month 6 after Dosing

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Degarelix 10 mg

EXPERIMENTAL

Drug: Degarelix 10 mg

Degarelix 20 mg

EXPERIMENTAL

Drug: Degarelix 20 mg

Degarelix 30 mg

EXPERIMENTAL

Drug: Degarelix 30 mg

Interventions

Placebo DRUG

Mannitol 50 mg/mL solution

Placebo

Degarelix 10 mg DRUG

10 mg degarelix, 40 mg/mL solution

Also known as: FE200486, Firmagon

Degarelix 10 mg

Degarelix 20 mg DRUG

20 mg degarelix, 40 mg/mL solution

Also known as: FE200486, Firmagon

Degarelix 20 mg

Degarelix 30 mg DRUG

30 mg degarelix, 40 mg/mL solution

Also known as: FE200486, Firmagon

Degarelix 30 mg

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (47)

Urology Centers of Alabama, PC

Homewood, Alabama, United States

Location

Coastal Clinical Research Inc

Mobile, Alabama, United States

Location

California Professional Research

Newport Beach, California, United States

Location

Genitourinary Surgical Consultants

Denver, Colorado, United States

Location

Urology Associates , PC

Englewood, Colorado, United States

Location

South Florida Medical Research

Aventura, Florida, United States

Location

Winter Park Urology Associates

Orlando, Florida, United States

Location

Pinellas Urology Inc

St. Petersburg, Florida, United States

Location

Florida Urology Partners

Tampa, Florida, United States

Location

Northwestern University

Chicago, Illinois, United States

Location

Weill Cornell Medical College New York Presbyterian

New York, New York, United States

Location

Hudson Valley Urology, PC

Poughkeepsie, New York, United States

Location

Duke University Medical Center

Durham, North Carolina, United States

Location

Patient Priority Clinical Sites, LLC

Cincinnati, Ohio, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Location

Middelheim Antwerp

Antwerp, Belgium

Location

UZ Brussel

Brussels, Belgium

Location

Can-Med Clinical Research Inc

Victoria, British Columbia, Canada

Location

Dr Steinhoff Clinical Research

Victoria, British Columbia, Canada

Location

Male/Female Health and Research Centre

Barrie, Ontario, Canada

Location

Bramalea Medical Centre

Brampton, Ontario, Canada

Location

Brandford Urology Research

Brantford, Ontario, Canada

Location

Guelp Urology

Guelph, Ontario, Canada

Location

Centre for Applied Urological Research

Kingston, Ontario, Canada

Location

Investigational Site

North Bay, Ontario, Canada

Location

Female/Male Health Centres

Oakville, Ontario, Canada

Location

Mahoney Medicine Professional Corporation

Ottawa, Ontario, Canada

Location

Todd Webster Ontario Inc

Owen Sound, Ontario, Canada

Location

Anthony Skehan Medicine Professional Corporation

Thunder Bay, Ontario, Canada

Location

The Male Health Centre

Toronto, Ontario, Canada

Location

McGill University Health Centre

Montreal, Quebec, Canada

Location

Ultra-Med Inc

Point-Claire, Quebec, Canada

Location

Urologie, Male namesti 1783

Benešov, Czechia

Location

Urocentrum Brno, Purkynova 35e

Brno, Czechia

Location

Prvni privatni chirurgicke centrum SANUS, Labská kotlina I/1220

Hradec Králové, Czechia

Location

Urologicka ambulance, Litomerice (Halek)

Litoměřice, Czechia

Location

Slezska nemocnice, prospevkova organizace, Urologicke oddeleni

Opava, Czechia

Location

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

Prague, Czechia

Location

Urocentrum, Karlovo namesti 3

Prague, Czechia

Location

Urologica ambulance, Praha 10

Prague, Czechia

Location

Ústecké urocentrum, Ústi nad Labem (Liehne)

Ústi Nad Labem, Czechia

Location

Urologia, A.O. San Giuseppe Moscati, Avellino

Avellino, Italy

Location

Unità Operativa di Urologia, Azienda Opsedaliera Luigi Sacco

Milan, Italy

Location

Unità Operativa di Urologia, Ospedale San Raffaele

Milan, Italy

Location

Akademia Medyczna w Gdansku

Gdansk, Poland

Location

Publiczny Specjalistyczny ZOZ

Inowrocław, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr.1

Zabrze, Poland

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Following the planned 6-month interim analysis when all patients had completed the visit scheduled 6 months after dosing, a decision was taken to stop the trial since the primary efficacy endpoint was not met.

Results Point of Contact

• Title: Clinical Development Support
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2009
• First Posted: July 28, 2009
• Study Start: August 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 8, 2015
• Results First Posted: May 14, 2015

Record last verified: 2015-05

Locations

US (15); BE (2); CA (15); CZ (9); PL (3); IT (3)