CompletedNCT00947882DELUTSUpdated Jun 8, 2015Results posted

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

A Phase 2 interventional study of Placebo and Degarelix 10 mg in Lower Urinary Tract Symptoms (LUTS), sponsored by Ferring Pharmaceuticals. Completed at 47 sites in 6 countries. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2015-06-08.

Sponsored by Ferring Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 404
Allocation: Randomized
Ages: 50 Years and older
Sex: Male

Study 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 studied

Lower Urinary Tract Symptoms (LUTS)

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In context

Prostatic Hyperplasia

783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's enrollment of 404 is above the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

Ferring Pharmaceuticals is the lead sponsor of 244 studies on the registry; 4 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 13 (93%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 50 Years and older
Sexes eligible: Male
Accepts healthy volunteers: No

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

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 design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 404 participants (actual)

Study arms

Placebo comparator
Placebo
Drug: Placebo
Experimental
Degarelix 10 mg
Drug: Degarelix 10 mg
Experimental
Degarelix 20 mg
Drug: Degarelix 20 mg
Experimental
Degarelix 30 mg
Drug: Degarelix 30 mg

Interventions

DrugPlacebo
Mannitol 50 mg/mL solution
DrugDegarelix 10 mg
10 mg degarelix, 40 mg/mL solution
Also known as: FE200486, Firmagon
DrugDegarelix 20 mg
20 mg degarelix, 40 mg/mL solution
Also known as: FE200486, Firmagon
DrugDegarelix 30 mg
30 mg degarelix, 40 mg/mL solution
Also known as: FE200486, Firmagon

What researchers measure

Primary outcomes

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.
Time frame: From Baseline to Month 3 after Dosing

Secondary outcomes

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.
Time frame: From Baseline to Month 4, Month 5 and Month 6 after Dosing
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.
Time frame: At Month 3, Month 4, Month 5 and Month 6 after Dosing
Mean Percentage Change in Total Prostate Volume (TPV)
TPV was measured directly by standardised trans-rectal ultrasound (TRUS).
Time frame: From Baseline to Month 3 and Month 6 after Dosing
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).
Time frame: From Baseline to Month 3 and Month 6 after Dosing

Results

Posted May 14, 2015

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.

Participant flow

Patients who met the eligibility criteria were randomised in a 1:1:1:1 manner to 1 of the 4 treatment groups in this trial. The randomisation was stratified by region (North America and Europe) and prostate volume (\<30 mL and ≥30 mL). 404 patients were randomised and received a single dose of placebo, 10 mg, 20 mg, or 30 mg degarelix.

Participant flow — Overall Study
Milestone	Placebo	Degarelix 10 mg	Degarelix 20 mg	Degarelix 30 mg
Started	100	101	101	102
Full analysis set (fas)	100	101	100	102
Actual treatment	98	101	100	105
Safety analysis set	98	101	100	105
Visit 12, month 6	93	91	90	95
Completed	26	24	22	20
Not completed	74	77	79	82
Withdrew: Adverse event	0	1	4	4
Withdrew: Withdrawal by subject	2	0	8	2
Withdrew: Protocol violation	0	0	1	0
Withdrew: Lost to follow-up	0	2	1	0
Withdrew: Other/unknown	10	13	3	6
Withdrew: Trial terminated by sponsor	62	61	62	70

Outcome measures

PrimaryMean 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.

Time frame:: From Baseline to Month 3 after Dosing
Reported as:: Mean · percentage change from baseline

Mean Change in International Prostate Symptom Score (IPSS)
percentage change from baseline	Placebo	Degarelix 10 mg	Degarelix 20 mg	Degarelix 30 mg
Mean Change in International Prostate Symptom Score (IPSS)	-4.46 ± 5.34	-5.65 ± 6.03	-6.11 ± 5.7	-5.88 ± 5.97

Statistical analysis

Placebo vs Degarelix 30 mg · Step-down, Williams' extended trend test · p = 0.0911 (P-value based on Williams' extended trend test of comparison vs. placebo at Month 3. No adjustment for multiple comparisons was made.) · Mean difference (final values): -1.30Treatment difference between "Degarelix 30 mg" and "Placebo" at Month 3.
Placebo vs Degarelix 20 mg · Step-down, Williams' extended trend test · p = 0.0865 (P-value based on Williams' extended trend test of comparison vs. placebo at Month 3. No adjustment for multiple comparisons was made.) · Mean difference (final values): -1.44Treatment difference between "Degarelix 20 mg" and "Placebo" at Month 3.
Placebo vs Degarelix 10 mg · Step-down, Williams' extended trend test · p = 0.2342 (P-value based on Williams' extended trend test of comparison vs. placebo at Month 3. No adjustment for multiple comparisons was made.) · Mean difference (final values): -0.92Treatment difference between "Degarelix 10 mg" and "Placebo" at Month 3.

SecondaryMean 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.

Time frame:: From Baseline to Month 4, Month 5 and Month 6 after Dosing
Reported as:: Mean · percentage change from baseline

Mean Change in IPSS
percentage change from baseline	Placebo	Degarelix 10 mg	Degarelix 20 mg	Degarelix 30 mg
Mean Percentage Change at Month 4	-4.12 ± 5.65	-5.52 ± 6.18	-6.3 ± 6.38	-5.64 ± 5.6
Mean Percentage Change at Month 5	-4.34 ± 5.94	-5.59 ± 6.89	-6.1 ± 6.46	-5.37 ± 5.97
Mean Percentage Change at Month 6	-4.3 ± 5.47	-5.42 ± 6.7	-5.72 ± 5.59	-5.62 ± 5.69

Statistical analysis

Placebo vs Degarelix 30 mg · Step-down, Williams' extended trend test · p = 0.0367 (P-values based on Williams' extended trend test of comparison vs. placebo at Month 4. No adjustment for multiple comparisons was made.) · Mean difference (final values): -1.62Treatment difference between "Degarelix 30 mg" and "Placebo" at Month 4.
Placebo vs Degarelix 20 mg · Step-down, Williams' extended trend test · p = 0.0231 (P-value based on Williams' extended trend test of comparison vs. placebo at Month 4. No adjustment for multiple comparisons was made.) · Mean difference (final values): -1.97Treatment difference between "Degarelix 20 mg" and "Placebo" at Month 4.
Placebo vs Degarelix 10 mg · Step-down, Williams' extended trend test · p = 0.1638 (P-value based on Williams' extended trend test of comparison vs. placebo at Month 4. No adjustment for multiple comparisons was made.) · Mean difference (final values): -1.11Treatment difference between "Degarelix 10 mg" and "Placebo" at Month 4.
Placebo vs Degarelix 30 mg · Step-down, Williams' extended trend test · p = 0.1941 (P-values based on Williams' extended trend test of comparisons vs. placebo at Month 5. No adjustment for multiple comparison was made.) · Mean difference (final values): -1.14Treatment difference between "Degarelix 30 mg" and "Placebo" at Month 5.
Placebo vs Degarelix 20 mg · Step-down, Williams' extended trend test · p = 0.1083 (P-value based on Williams' extended trend test of comparison vs. placebo at Month 5. No adjustment for multiple comparisons was made.) · Mean difference (final values): -1.54Treatment difference between "Degarelix 20 mg" and "Placebo" at Month 5.
Placebo vs Degarelix 10 mg · Step-down, Williams' extended trend test · p = 0.2782 (P-value based on Williams' extended trend test of comparison vs. placebo at Month 5. No adjustment for multiple comparisons was made.) · Mean difference (final values): -0.95Treatment difference between "Degarelix 10 mg" and "Placebo" at Month 5.
Placebo vs Degarelix 30 mg · Step-down, Williams' extended trend test · p = 0.1562 (P-values based on Williams' extended trend test of comparison vs. placebo at Month 6. No adjustment for multiple comparisons was made.) · Mean difference (final values): -1.15Treatment difference between "Degarelix 30 mg" and "Placebo" at Month 6.
Placebo vs Degarelix 20 mg · Step-down, Williams' extended trend test · p = 0.1736 (P-value based on Williams' extended trend test of comparison vs. placebo at Month 6. No adjustment for multiple comparisons was made.) · Mean difference (final values): -1.24Treatment difference between "Degarelix 20 mg" and "Placebo" at Month 6.
Placebo vs Degarelix 10 mg · Step-down, Williams' extended trend test · p = 0.3132 (P-value based on Williams' extended trend test of comparison vs. placebo at Month 6. No adjustment for multiple comparisons was made.) · Mean difference (final values): -0.84Treatment difference between "Degarelix 10 mg" and "Placebo" at Month 6.

SecondaryOdds 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.

Time frame:: At Month 3, Month 4, Month 5 and Month 6 after Dosing
Reported as:: Number · percentage of participants

Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS
percentage of participants	Placebo	Degarelix 10 mg	Degarelix 20 mg	Degarelix 30 mg
3-point reduction in IPSS vs. baseline (Month 3)	59.0	72.3	69.0	68.6
3-point reduction in IPSS vs. baseline (Month 4)	57.0	65.3	71.0	70.6
3-point reduction in IPSS vs. baseline (Month 5)	61.0	64.4	66.0	67.6
3-point reduction in IPSS vs. baseline (Month 6)	62.0	68.3	67.0	71.6

Statistical analysis

Placebo vs Degarelix 30 mg · Regression, Logistic · p = 0.2034 (Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL). Unadjusted p-value of comparison vs. placebo at Month 3.) · Odds ratio (or): 1.46 · 95% CI 0.814 to 2.628Odds ratio of treatment response between "Degarelix 30 mg" and "Placebo" at Month 3.
Placebo vs Degarelix 20 mg · Regression, Logistic · p = 0.1748 (Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL). Unadjusted p-value of comparison vs. placebo at Month 3.) · Odds ratio (or): 1.50 · 95% CI 0.834 to 2.710Odds ratio of treatment response between "Degarelix 20 mg" and "Placebo" at Month 3.
Placebo vs Degarelix 10 mg · Regression, Logistic · p = 0.0658 (Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL). Unadjusted p-value of comparison vs. placebo at Month 3.) · Odds ratio (or): 1.75 · 95% CI 0.964 to 3.195Odds ratio of treatment response between "Degarelix 10 mg" and "Placebo" at Month 3.
Placebo vs Degarelix 30 mg · Regression, Logistic · p = 0.0587 (Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL). Unadjusted p-value of comparison vs. placebo at Month 4.) · Odds ratio (or): 1.77 · 95% CI 0.979 to 3.184Odds ratio of treatment response between "Degarelix 30 mg" and "Placebo" at Month 4.
Placebo vs Degarelix 20 mg · Regression, Logistic · p = 0.0490 (Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL). Unadjusted p-value of comparison vs. placebo at Month 4.) · Odds ratio (or): 1.81 · 95% CI 1.003 to 3.283Odds ratio of treatment response between "Degarelix 20 mg" and "Placebo" at Month 4.
Placebo vs Degarelix 10 mg · Regression, Logistic · p = 0.2742 (Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL). Unadjusted p-value of comparison vs. placebo at Month 4.) · Odds ratio (or): 1.38 · 95% CI 0.774 to 2.464Odds ratio of treatment response between "Degarelix 10 mg" and "Placebo" at Month 4.
Placebo vs Degarelix 30 mg · Regression, Logistic · p = 0.4206 (Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL). Unadjusted p-value of comparison vs. placebo at Month 5.) · Odds ratio (or): 1.28 · 95% CI 0.706 to 2.304Odds ratio of treatment response between "Degarelix 30 mg" and "Placebo" at Month 5.
Placebo vs Degarelix 20 mg · Regression, Logistic · p = 0.5494 (Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL). Unadjusted p-value of comparison vs. placebo at Month 5.) · Odds ratio (or): 1.20 · 95% CI 0.664 to 2.160Odds ratio of treatment response between "Degarelix 20 mg" and "Placebo" at Month 5.
Placebo vs Degarelix 10 mg · Regression, Logistic · p = 0.7586 (Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL). Unadjusted p-value of comparison vs. placebo at Month 5.) · Odds ratio (or): 1.10 · 95% CI 0.609 to 1.975Odds ratio of treatment response between "Degarelix 10 mg" and "Placebo" at Month 5.
Placebo vs Degarelix 30 mg · Regression, Logistic · p = 0.1946 (Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL). Unadjusted p-value of comparison vs. placebo at Month 6.) · Odds ratio (or): 1.49 · 95% CI 0.816 to 2.717Odds ratio of treatment response between "Degarelix 30 mg" and "Placebo" at Month 6.
Placebo vs Degarelix 20 mg · Regression, Logistic · p = 0.5380 (Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL). Unadjusted p-value of comparison vs. placebo at Month 6.) · Odds ratio (or): 1.20 · 95% CI 0.667 to 2.174Odds ratio of treatment response between "Degarelix 20 mg" and "Placebo" at Month 6.
Placebo vs Degarelix 10 mg · Regression, Logistic · p = 0.4263 (Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL). Unadjusted p-value of comparison vs. placebo at Month 6.) · Odds ratio (or): 1.27 · 95% CI 0.702 to 2.308Odds ratio of treatment response between "Degarelix 10 mg" and "Placebo" at Month 6.

SecondaryMean Percentage Change in Total Prostate Volume (TPV)

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

Time frame:: From Baseline to Month 3 and Month 6 after Dosing
Reported as:: Mean · percentage change from baseline

Mean Percentage Change in Total Prostate Volume (TPV)
percentage change from baseline	Placebo	Degarelix 10 mg	Degarelix 20 mg	Degarelix 30 mg
Mean Percentage Change at Month 3	3.15 ± 23.3	-1.46 ± 32.7	-0.252 ± 24.5	0.188 ± 24.4
Mean Percentage Change at Month 6	3.96 ± 29.3	1.57 ± 31	2.35 ± 26.5	-0.0112 ± 20.9

Statistical analysis

Placebo vs Degarelix 30 mg · ANCOVA · p = 0.4607 (No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.) · Mean difference (final values): -2.76 · 95% CI -10.113 to 4.590Treatment difference between "Degarelix 30 mg" and "Placebo" at Month 3.
Placebo vs Degarelix 20 mg · ANCOVA · p = 0.3876 (No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.) · Mean difference (final values): -3.24 · 95% CI -10.614 to 4.128Treatment difference between "Degarelix 20 mg" and "Placebo" at Month 3.
Placebo vs Degarelix 10 mg · ANCOVA · p = 0.2548 (No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.) · Mean difference (final values): -4.28 · 95% CI -11.650 to 3.096Treatment difference between "Degarelix 10 mg" and "Placebo" at Month 3.
Placebo vs Degarelix 30 mg · ANCOVA · p = 0.5652 (No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.) · Mean difference (final values): -2.20 · 95% CI -9.729 to 5.322Treatment difference between "Degarelix 30 mg" and "Placebo" at Month 6.
Placebo vs Degarelix 20 mg · ANCOVA · p = 0.7502 (No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.) · Mean difference (final values): -1.22 · 95% CI -8.768 to 6.322Treatment difference between "Degarelix 20 mg" and "Placebo" at Month 6.
Placebo vs Degarelix 10 mg · ANCOVA · p = 0.6089 (No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.) · Mean difference (final values): -1.97 · 95% CI -9.513 to 5.581Treatment difference between "Degarelix 10 mg" and "Placebo" at Month 6.

SecondaryMean 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).

Time frame:: From Baseline to Month 3 and Month 6 after Dosing
Reported as:: Mean · percentage change from baseline

Mean Change in Maximum Urinary Flow (Qmax)
percentage change from baseline	Placebo	Degarelix 10 mg	Degarelix 20 mg	Degarelix 30 mg
Mean Percentage Change at Month 3	0.652 ± 3.8	0.564 ± 5.08	0.626 ± 5.68	0.723 ± 3.91
Mean Percentage Change at Month 6	1.04 ± 5.34	0.516 ± 4.85	0.582 ± 5.43	1.43 ± 5.29

Statistical analysis

Placebo vs Degarelix 30 mg · ANCOVA · p = 0.8511 (No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.) · Mean difference (final values): 0.11 · 95% CI -1.068 to 1.294Treatment difference between "Degarelix 30 mg" and "Placebo" at Month 3.
Placebo vs Degarelix 20 mg · ANCOVA · p = 0.6331 (No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.) · Mean difference (final values): 0.29 · 95% CI -0.900 to 1.477Treatment difference between "Degarelix 20 mg" and "Placebo" at Month 3.
Placebo vs Degarelix 10 mg · ANCOVA · p = 0.9090 (No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.) · Mean difference (final values): 0.07 · 95% CI -1.113 to 1.250Treatment difference between "Degarelix 10 mg" and "Placebo" at Month 3.
Placebo vs Degarelix 30 mg · ANCOVA · p = 0.5469 (No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.) · Mean difference (final values): 0.42 · 95% CI -0.956 to 1.802Treatment difference between "Degarelix 30 mg" and "Placebo" at Month 6.
Placebo vs Degarelix 20 mg · ANCOVA · p = 0.7906 (No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.) · Mean difference (final values): -0.19 · 95% CI -1.576 to 1.200Treatment difference between "Degarelix 20 mg" and "Placebo" at Month 6.
Placebo vs Degarelix 10 mg · ANCOVA · p = 0.5757 (No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.) · Mean difference (final values): -0.39 · 95% CI -1.773 to 0.987Treatment difference between "Degarelix 10 mg" and "Placebo" at Month 6.

Adverse events

Collected over This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	—	2/98 (2%)	31/98 (31.6%)
Degarelix 10 mg	—	8/101 (7.9%)	35/101 (34.7%)
Degarelix 20 mg	—	2/100 (2%)	39/100 (39%)
Degarelix 30 mg	—	7/105 (6.7%)	56/105 (53.3%)

Most frequent serious events

Showing 10 of 24

Most frequent serious events
Event	Placebo	Degarelix 10 mg	Degarelix 20 mg	Degarelix 30 mg
Angina pectorisCardiac disorders	1/98	0/101	0/100	0/105
Abdominal pain upperGastrointestinal disorders	1/98	0/101	0/100	0/105
Coagulation time prolongedInvestigations	1/98	0/101	0/100	0/105
Nasal septum deviationRespiratory, thoracic and mediastinal disorders	1/98	0/101	0/100	0/105
Clostridium difficile colitisInfections and infestations	0/98	0/101	1/100	0/105
Intervertebral disc protrusionMusculoskeletal and connective tissue disorders	0/98	0/101	1/100	1/105
Sick sinus syndromeCardiac disorders	0/98	1/101	0/100	0/105
IleusGastrointestinal disorders	0/98	1/101	0/100	0/105
SubileusGastrointestinal disorders	0/98	1/101	0/100	0/105
Abscess intestinalInfections and infestations	0/98	1/101	0/100	0/105

Most frequent other events

Showing 10 of 11

Most frequent other events
Event	Placebo	Degarelix 10 mg	Degarelix 20 mg	Degarelix 30 mg
Injection site erythemaGeneral disorders	0/98	11/101	14/100	18/105
Injection site painGeneral disorders	0/98	2/101	10/100	18/105
Injection site indurationGeneral disorders	0/98	6/101	7/100	11/105
Back painMusculoskeletal and connective tissue disorders	9/98	5/101	5/100	5/105
HypertensionVascular disorders	7/98	6/101	4/100	9/105
Hot flushVascular disorders	1/98	1/101	4/100	8/105
NasopharyngitisInfections and infestations	5/98	7/101	2/100	5/105
Prostatic specific antigen increasedInvestigations	6/98	4/101	5/100	6/105
InfluenzaInfections and infestations	5/98	5/101	3/100	5/105
HeadacheNervous system disorders	5/98	3/101	3/100	3/105

Baseline characteristics

FAS. The efficacy analyses were based on the "as planned" treatment. Three patients deviated from the planned dosing and were included in the planned treatment groups in the FAS (i.e. not in the actual treatment groups as for the Safety Analysis Set).

Age, Continuous
Age, Continuous(years)	Placebo	Degarelix 10 mg	Degarelix 20 mg	Degarelix 30 mg	Total
Mean	65.2 ± 7.86	64.9 ± 7.89	65.7 ± 7.12	65.4 ± 7.56	65.3 ± 7.59

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	Degarelix 10 mg	Degarelix 20 mg	Degarelix 30 mg	Total
Female	0	0	0	0	0
Male	100	101	100	102	403

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Placebo	Degarelix 10 mg	Degarelix 20 mg	Degarelix 30 mg	Total
Hispanic or Latino	1	4	0	4	9
Not Hispanic or Latino	99	97	100	98	394
Unknown or Not Reported	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Placebo	Degarelix 10 mg	Degarelix 20 mg	Degarelix 30 mg	Total
American Indian or Alaska Native	0	1	0	1	2
Asian	0	1	1	2	4
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	4	3	3	3	13
White	96	96	96	96	384
More than one race	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Placebo	Degarelix 10 mg	Degarelix 20 mg	Degarelix 30 mg	Total
North America	59	60	61	60	240
Europe	41	41	39	42	163

Baseline Body Mass Index (BMI)
Baseline Body Mass Index (BMI)((kg/m^2))	Placebo	Degarelix 10 mg	Degarelix 20 mg	Degarelix 30 mg	Total
Mean	28.5 ± 3.66	28.4 ± 3.93	27.9 ± 3.84	28.2 ± 4.81	28.2 ± 4.08

Baseline International Prostate Symptom Scores (IPSS)
Baseline International Prostate Symptom Scores (IPSS)(units on a scale)	Placebo	Degarelix 10 mg	Degarelix 20 mg	Degarelix 30 mg	Total
Mean	19.1 ± 4.38	19.9 ± 5.21	19.6 ± 4.42	19.8 ± 4.88	19.6 ± 4.73

Baseline Total Prostate Volume (TPV)
Baseline Total Prostate Volume (TPV)(mL)	Placebo	Degarelix 10 mg	Degarelix 20 mg	Degarelix 30 mg	Total
Mean	41.6 ± 17.8	42.9 ± 18.8	42.3 ± 20.2	42.1 ± 20.2	42.2 ± 19.2

1 further baseline measures are reported on the registry.

Study locations

47 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 8, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00947882
Lead sponsor: Ferring Pharmaceuticals
Responsible party: Sponsor
First posted: Jul 28, 2009
Start date: Aug 2009
Primary completion: Mar 2011
Completion: Jun 2011
Results posted: May 14, 2015
Last update: Jun 8, 2015

Study contacts

Clinical Development Support

study director · Ferring Pharmaceuticals

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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