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Phase 3 N=511 Randomized Triple-blind Treatment

A Study of Tadalafil in Men With Benign Prostatic Hyperplasia

Benign Prostatic Hyperplasia (BPH)

Bottom Line

View on ClinicalTrials.gov: NCT00970632 ↗
Enrolled (actual)
511
Serious AEs
0.8%
Results posted
Dec 2011
Primary outcome: Primary: Change From Baseline in Total International Prostate Symptom Score (IPSS) at 12 Weeks — -4.2; -6.3; -5.7 units on a scale — p=0.001

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Tadalafil 5 mg (Drug); Placebo tablet (Drug); Tamsulosin (Drug); Placebo capsule (Drug)
Age
Adult, Older Adult · 45+ yrs
Sex
Male
Sponsor
Eli Lilly and Company
Primary completion
Jan 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Total International Prostate Symptom Score (IPSS) at 12 Weeks		 -4.2; -6.3; -5.7 0.001 sig
SECONDARY
Change From Baseline in Total International Prostate Symptom Score (IPSS) at 4 Weeks		 -3.3; -5.5; -5.7 <0.001 sig
SECONDARY
Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12 Weeks		 -1.6; -2.2; -2.2 0.055
SECONDARY
Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12 Weeks.		 -2.6; -4.1; -3.5 <0.001 sig
SECONDARY
Change From Baseline in International Prostate Symptom Score (IPSS) Nocturia Question at 12 Weeks		 -0.3; -0.5; -0.5 0.080
SECONDARY
Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index at 12 Weeks		 -1.0; -1.3; -1.1 0.022 sig
SECONDARY
Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at 1 Week		 -2.5; -4.0; -4.0 0.003 sig
SECONDARY
Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 4 Weeks		 -0.4; -1.2; -1.3 <0.001 sig
SECONDARY
Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 12 Weeks		 -0.9; -1.7; -1.5 0.003 sig
SECONDARY
Patient Global Impression of Improvement (PGI-I) at 12 Weeks		 2; 0; 0; 2; 1; 0 0.001 sig
SECONDARY
Clinician Global Impression of Improvement (CGI-I) at 12 Weeks		 1; 0; 0; 2; 2; 1 0.004 sig
SECONDARY
Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 12 Weeks: Overall		 28.9; 22.2; 28.9 0.005 sig
SECONDARY
Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at 12 Weeks		 2.1; 6.0; 1.7 <0.001 sig
SECONDARY
Change From Baseline in Peak Urine Flow Rate (Q-Max) at 12 Weeks		 0.3; 1.6; 1.6 0.009 sig
SECONDARY
Change From Baseline in Mean Urine Flow Rate (Q-Mean) at 12 Weeks		 0.10; 1.25; 0.70 —
SECONDARY
Change From Baseline in Volume of Voided Urine (V-Comp) at 12 Weeks		 0.0; 11.0; 16.0 —
SECONDARY
Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks		 0.0; -1.0; -5.5 0.303

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.)

Eligibility Criteria

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.

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00970632). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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