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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00970632
Registration number
NCT00970632
Ethics application status
Date submitted
1/09/2009
Date registered
2/09/2009
Date last updated
12/03/2012
Titles & IDs
Public title
A Study of Tadalafil in Men With Benign Prostatic Hyperplasia
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Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Global Multicenter Study to Evaluate the Efficacy and Safety of Tadalafil Once Daily Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
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Secondary ID [1]
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H6D-MC-LVID
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Secondary ID [2]
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12932
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hyperplasia (BPH)
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Condition category
Condition code
Renal and Urogenital
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Other renal and urogenital disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tadalafil 5 mg
Treatment: Drugs - Placebo tablet
Treatment: Drugs - Tamsulosin
Treatment: Drugs - Placebo capsule
Placebo Comparator: Placebo - Placebo tablet with tamsulosin dose orally (po) once daily (QD) and placebo capsule with tadalafil dose po QD for 12 weeks
Experimental: Tadalafil 5 milligram (mg) - Tadalafil 5 mg tablet po QD and placebo capsule po QD for 12 weeks
Active Comparator: Tamsulosin 0.4 mg - Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
Treatment: Drugs: Tadalafil 5 mg
Tadalafil 5 mg po QD for 12 weeks
Treatment: Drugs: Placebo tablet
Placebo tablet po QD for 12 weeks
Treatment: Drugs: Tamsulosin
Tamsulosin 0.4 mg po QD for 12 weeks
Treatment: Drugs: Placebo capsule
Placebo capsule po QD for 12 weeks
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Total International Prostate Symptom Score (IPSS) at 12 Weeks
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Assessment method [1]
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The IPSS Total Score was obtained by combining the scores of the responses to Component Questions 1-7. Each question was scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
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Timepoint [1]
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Baseline, 12 weeks
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Secondary outcome [1]
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Change From Baseline in Total International Prostate Symptom Score (IPSS) at 4 Weeks
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Assessment method [1]
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The IPSS Total Score was obtained by combining the scores of the responses to Component Questions 1-7. Each question was scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 4 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
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Timepoint [1]
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Baseline, 4 weeks
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Secondary outcome [2]
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Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12 Weeks
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Assessment method [2]
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IPSS storage (irritative) subscore was the sum of Component Questions 2, 4 and 7 of the IPSS questionnaire. Scores ranged from 0 (no irritative symptoms) to 5 (frequent irritative symptoms); therefore, the 3 questions of the irritative subscore ranged from 0 to 15. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
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Timepoint [2]
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Baseline, 12 weeks
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Secondary outcome [3]
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Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12 Weeks.
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Assessment method [3]
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IPSS voiding (obstructive) subscore was the sum of Component Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores ranged from 0 (no obstructive symptoms)-5 (frequent obstructive symptoms); therefore, the 4 questions of the obstructive score ranged from 0-20. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
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Timepoint [3]
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Baseline, 12 weeks
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Secondary outcome [4]
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Change From Baseline in International Prostate Symptom Score (IPSS) Nocturia Question at 12 Weeks
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Assessment method [4]
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The IPSS nocturia question (Component Question 7) measured nocturia (need to urinate at night) over the past 4 weeks. Scores ranged from 0 (no episodes of nocturia)-5 (5 or more episodes of nocturia). Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
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Timepoint [4]
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Baseline, 12 weeks
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Secondary outcome [5]
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Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index at 12 Weeks
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Assessment method [5]
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IPSS QoL assessed QoL by urinary symptoms, with scores ranging from 0 (delighted)-6 (terrible). Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
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Timepoint [5]
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Baseline, 12 weeks
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Secondary outcome [6]
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Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at 1 Week
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Assessment method [6]
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The mIPSS Total Score covered a time period of 1 week and was obtained by combining scores of responses to Component Questions 1-7. Each question was scored from 0-5 for an mIPSS range of 0-35 points; higher numerical scores represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 1 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
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Timepoint [6]
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Baseline, 1 week
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Secondary outcome [7]
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Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 4 Weeks
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Assessment method [7]
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BII was a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores ranged from 0-13; higher scores represented increased perceived impact of BPH-lower urinary tract symptoms (LUTS) on overall health. Least Squares (LS) Mean of change from baseline to endpoint (Week 4 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
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Timepoint [7]
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Baseline, 4 weeks
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Secondary outcome [8]
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Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 12 Weeks
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Assessment method [8]
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BII was a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores ranged from 0-13; higher scores represented increased perceived impact of BPH-lower urinary tract symptoms (LUTS) on overall health. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
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Timepoint [8]
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Baseline, 12 weeks
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Secondary outcome [9]
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Patient Global Impression of Improvement (PGI-I) at 12 Weeks
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Assessment method [9]
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The PGI-I was a participant-rated instrument that measured the improvement or worsening of the participant's symptoms based on a 7-point scale at Week 12. A score of 1=participant felt symptoms were "very much better"; score of 2=participant felt symptoms were "much better"; score of 3=participant felt symptoms were "a little better"; score of 4=participant felt "no change" in symptoms; score of 5=participant felt symptoms were "a little worse"; score of 6=participant felt symptoms were "much worse"; score of 7=participant felt symptoms were "very much worse".
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Timepoint [9]
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12 weeks
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Secondary outcome [10]
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Clinician Global Impression of Improvement (CGI-I) at 12 Weeks
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Assessment method [10]
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The CGI-I was an investigator-rated instrument that measured improvement or worsening of the participant's symptoms based on a 7-point scale. A score of 1=participant felt symptoms were "very much better"; score of 2=participant felt symptoms were "much better"; score of 3=participant felt symptoms were "a little better"; score of 4=participant felt "no change" in symptoms; score of 5=participant felt symptoms were "a little worse"; score of 6=participant felt symptoms were "much worse"; score of 7=participant felt symptoms were "very much worse".
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Timepoint [10]
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12 weeks
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Secondary outcome [11]
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Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 12 Weeks: Overall
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Assessment method [11]
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The TSS-BPH was a validated participant-rated instrument that measured participant satisfaction with treatment based on a 13-item questionnaire. The overall TSS-BPH score was converted to a percentage of the maximum value possible (percent ranged from 0-100) with lower scores indicating greater satisfaction.
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Timepoint [11]
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12 weeks
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Secondary outcome [12]
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Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at 12 Weeks
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Assessment method [12]
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IIEF measured self-reported EF over the past 4 weeks. Scores ranged from 0 (low or no EF)-5 (high EF) on 6 questions (1-5, 15 of the IIEF). Total EF Domain scores ranged from 1-30. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
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Timepoint [12]
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Baseline, 12 weeks
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Secondary outcome [13]
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Change From Baseline in Peak Urine Flow Rate (Q-Max) at 12 Weeks
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Assessment method [13]
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Q-max (peak urine flow rate) was measured in milliliters per second (mL/sec) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was =150 to =550 mL and the voided volume (V-comp) was =125 mL.
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Timepoint [13]
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Baseline, 12 weeks
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Secondary outcome [14]
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Change From Baseline in Mean Urine Flow Rate (Q-Mean) at 12 Weeks
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Assessment method [14]
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Q-mean (mean urine flow rate) was measured in milliliters per second (mL/sec) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was =150 to =550 mL and the voided volume (V-comp) was >=125 mL.
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Timepoint [14]
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Baseline, 12 weeks
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Secondary outcome [15]
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Change From Baseline in Volume of Voided Urine (V-Comp) at 12 Weeks
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Assessment method [15]
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V-comp (volume of urine voided) was measured in milliliters (mL) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was =150 to =550 mL and V-comp was =125 mL.
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Timepoint [15]
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Baseline, 12 weeks
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Secondary outcome [16]
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Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks
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Assessment method [16]
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PVR was the amount of urine remaining in the bladder after void completion.
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Timepoint [16]
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Baseline, 12 weeks
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Eligibility
Key inclusion criteria
- Men 45 years of age or older with benign prostatic hyperplasia (BPH) also referred to
as BPH-lower urinary tract symptoms (LUTS) on the disease diagnostic criteria at the
start of study.
- Provide signed informed consent at the start of the study.
- Agree not to use any other approved or experimental pharmacologic BPH, overactive
bladder (OAB), or erectile dysfunction (ED) treatments anytime during the study.
- Have not taken finasteride therapy for at least 3 months before study drug is
dispensed and dutasteride therapy for at least 6 months before study drug is
dispensed.
- Have not taken other BPH therapy (including herbal preparations), OAB therapy, ED
therapy for at least 4 weeks prior to study drug is dispensed.
- Have LUTS with a total International Prostate Symptom Score (IPSS) greater than or
equal to 13 when study drug is dispensed.
- Have reduced urine flow (measured by special toilet equipment).
- Demonstrate compliance with study drug administration requirements.
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Minimum age
45
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Treated with nitrates
- Have unstable angina or angina that requires treatment.
- Have had any of the following in the past 90 days: Heart attack, also known as a
myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft
surgery); Had a procedure to open up blood vessels in the heart known as angioplasty
or stent placement (percutaneous coronary intervention).
- Have very high or very low blood pressure.
- Have certain neurological conditions associated with bladder problems or injuries to
brain or spinal cord within a specified time of starting this study.
- Have uncontrolled diabetes.
- Have prostate cancer, are being treated for cancer.
- Have prostate specific antigen (PSA) greater than 10 nanograms per milliliter (ng/mL)
at the start of study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2011
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Sample size
Target
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Accrual to date
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Final
511
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Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
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Recruitment hospital [1]
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Adelaide
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Recruitment hospital [2]
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Bentleigh East
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Recruitment hospital [3]
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Bunbury
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Recruitment hospital [4]
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Nedlands
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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3165 - Bentleigh East
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Recruitment postcode(s) [3]
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6230 - Bunbury
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Recruitment postcode(s) [4]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Salzburg
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Austria
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Vienna
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Belgium
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Brussels
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Belgium
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Gent
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Belgium
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Liege
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France
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Garches
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France
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Nice
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France
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Orleans
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France
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Paris
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France
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State/province [10]
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Pierre Benite
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France
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Suresnes
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Germany
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Bad Rappenau
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Germany
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Bad Wiessee
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Germany
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Hannover
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Germany
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Leipzig
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Germany
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Marburg
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Germany
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Muehlacker
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Germany
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Oranienburg
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Greece
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Heraklion
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Greece
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Ioannina
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Larissa
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Greece
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Patras
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Greece
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Thessaloniki
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Italy
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Bergamo
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Italy
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Cagliari
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Italy
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Firenze
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Italy
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Napoli
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Italy
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Sassari
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Mexico
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Monterrey
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Mexico
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Morelia
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Mexico
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Saltillo
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Mexico
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Zapopan
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Netherlands
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Arnhem
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Netherlands
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Breda
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Netherlands
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S-Hertogenbosch
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Netherlands
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Tilburg
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Netherlands
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Veldhoven
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Poland
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Bialystok
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Poland
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Kutno
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Poland
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State/province [40]
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Warsaw
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine whether an experimental drug known as tadalafil
given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia
(straining, urinary frequency, feeling like your bladder is still full etc.)
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00970632
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
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Address
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Eli Lilly and Company
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00970632
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