Phase 3 N=325 Randomized Double-blind Treatment

Study to Treat Patients Who Have Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) With Tadalafil Daily

Benign Prostatic Hyperplasia

Bottom Line

View on ClinicalTrials.gov: NCT00827242 ↗

Enrolled (actual)

325

Serious AEs

0.6%

Results posted

Nov 2010

Primary outcome: Primary: Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) — -5.6; -3.6 Units on a Scale — p=0.004

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Placebo (Drug); tadalafil (Drug)
Age: Adult, Older Adult · 45+ yrs
Sex: Male
Sponsor: Eli Lilly and Company
Primary completion: Nov 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS)	-5.6; -3.6	0.004 sig
SECONDARY Change From Baseline to 4 Weeks, Benign Prostatic Hyperplasia (BPH) Impact Index	-1.8; -1.2	0.029 sig
SECONDARY Change From Baseline to 12 Weeks, Benign Prostatic Hyperplasia (BPH) Impact Index	-1.8; -1.3	0.057
SECONDARY Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore	-2.3; -1.3	0.002 sig
SECONDARY Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore	-3.3; -2.3	0.020 sig
SECONDARY Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Nocturia Question	-0.5; -0.4	0.233
SECONDARY Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index	-1.0; -0.7	0.013 sig
SECONDARY Patient Global Impression of Improvement (PGI-I), Number of Participants in 7 Response Categories	1; 0; 5; 6; 4; 4	0.021 sig
SECONDARY Clinical Global Impression of Improvement (CGI-I), Number of Participants in 7 Response Categories	0; 0; 5; 2; 4; 10	0.009 sig
SECONDARY Change From Baseline to 1 Week, International Prostate Symptom Score (IPSS)	-3.4; -2.7	0.146
SECONDARY Change From Baseline to 4 Weeks, International Prostate Symptom Score (IPSS)	-5.3; -3.5	0.003 sig
SECONDARY Change From Baseline to 12 Weeks, International Index of Erectile Function (IIEF)- Erectile Function (EF) Domain Scores	6.7; 2.0	<0.001 sig
SECONDARY Change From Baseline to 12 Weeks, Peak Flow Rate (Qmax) by Uroflowmetry	1.6; 1.1	0.300
SECONDARY Change From Baseline to 12 Weeks, Mean Flow Rate (Qmean) by Uroflowmetry	0.6; 0.5	—
SECONDARY Change From Baseline to 12 Weeks, Voided Volume (Vcomp) by Uroflowmetry	16.9; 3.9	—
SECONDARY Change From Baseline to 12 Weeks, Postvoid Residual (PVR) Volume	8.8; 4.5	0.500

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-LUTS [lower urinary tract symptoms] based on the disease diagnostic criteria at the start of study.
Provide signed informed consent at the start of 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), overactive bladder (OAB) therapy, or erectile dysfunction (ED) therapy for at least 4 weeks prior to study drug is dispensed.
Agree not to use any other approved or experimental pharmacologic BPH, OAB, or ED treatments anytime during the study
Have LUTS with a Total International Prostate Symptom Score (IPSS) greater than or equal to 13 when study drug is dispensed.
Have reduced peak urine flow rate when study drug is dispensed (measured by a special toilet equipment).
Demonstrate compliance with study drug administration requirements.

Exclusion Criteria

Treated with nitrates for a cardiac conditions.
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 problems with kidneys, liver, or nervous system.
Have uncontrolled diabetes.
Have had a stroke or a significant injury to brain or spinal cord.
Have prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer (Prostate-Specific Antigen [PSA] greater than 10 nanograms/milliliter [ng/ml] at the start of study).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00827242). 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.