Phase 2 N=200 Randomized Double-blind Treatment

Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Benign Prostatic Hyperplasia

Bottom Line

View on ClinicalTrials.gov: NCT00386009 ↗

Enrolled (actual)

200

Serious AEs

—

Results posted

Jun 2009

Primary outcome: Primary: Change From Baseline to 12 Week Endpoint in Detrusor Pressure at Peak Urinary Flow Rate (PdetQmax) — 54.83; 56.87; 1.92; -2.95 centimeters of water (cm H20) — p=0.068

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Tadalafil (Drug); Placebo (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: Male
Sponsor: Eli Lilly and Company
Primary completion: May 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to 12 Week Endpoint in Detrusor Pressure at Peak Urinary Flow Rate (PdetQmax)	54.83; 56.87; 1.92; -2.95	0.068
SECONDARY Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Free-Flow Studies	13.03; 14.75; 0.52; 0.01	0.626
SECONDARY Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Free-Flow Studies	7.10; 7.23; -0.01; 1.00	0.113
SECONDARY Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Free-Flow Studies	258.56; 268.22; -4.10; -5.17	0.837
SECONDARY Change From Baseline to 12 Week Endpoint in Postvoid Residual Volume (PVRcath) Measured During Free-Flow Studies	59.62; 48.99; -1.85; -9.13	0.400
SECONDARY Change From Baseline to 12 Week Endpoint in Total Bladder Capacity Measured During Free-Flow Studies	327.95; 316.79; -17.53; -14.88	0.864
SECONDARY Change From Baseline to 12 Week Endpoint in Bladder Voiding Efficiency (BVE) Measured During Free-Flow Studies	84.01; 85.85; -0.52; 1.85	0.340
SECONDARY Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Pressure-Flow Studies	9.49; 10.29; 0.50; 0.38	0.838
SECONDARY Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Pressure-Flow Studies	4.67; 5.50; 0.45; 0.58	0.609
SECONDARY Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Pressure-Flow Studies	294.10; 296.64; 3.31; 13.51	0.427
SECONDARY Change From Baseline to 12 Week Endpoint in Maximum Detrusor Pressure (Max Pdet) Measured During Pressure-Flow Studies	67.13; 72.20; -0.48; -2.11	0.838
SECONDARY Change From Baseline to 12 Week Endpoint in Bladder Contractility Index (BCI) Measured During Pressure-Flow Studies	102.28; 108.32; 4.43; -1.04	0.090
SECONDARY Change From Baseline to 12 Week Endpoint in Bladder Outlet Obstruction Index (BOOI) Measured During Pressure-Flow Studies	35.84; 36.28; 0.92; -3.71	0.113
SECONDARY Presence of Involuntary Detrusor Contractions During Bladder Filling	33; 28; 58; 56; 36; 31	—
SECONDARY Change From Baseline to 12 Week Endpoint in Bladder Volume at First Involuntary Detrusor Contraction	120.55; 164.00; 27.86; 28.56	—
SECONDARY Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score	22.01; 21.46; -5.04; -9.13	<0.001 sig
SECONDARY Clinically Adverse and Statistically Significant Changes From Baseline to 12 Week Endpoint in Laboratory Tests	0; 0	—

Summary

The purpose of this study is to evaluate the function of the bladder and urethra during urinary storage or voiding in men with signs and symptoms of benign prostatic hyperplasia treated with either placebo or tadalafil.

Eligibility Criteria

Inclusion Criteria

Men 40 years of age or older with Lower Urinary Tract Symptoms (LUTS) with a total International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 1.
Agree not to use any other approved or experimental medications for Benign Prostate Hyperplasia (BPH)-Lower Urinary Tract Symptoms, including alpha blockers, 5-alpha reductase inhibitors, PDE5 inhibitors, or herbal preparations at any time during the study.
Have not taken finasteride or dutasteride therapy for at least 4 months prior to Visit 2; have not taken any other LUTS therapy (including herbal preparations) or PDE5 inhibitors for at least 4 weeks prior to Visit 2.
Have had BPH-LUTS for greater than 6 months prior to Visit 1.

Exclusion Criteria

Any pelvic surgical procedure on the urinary tract, including minimally invasive BPH-LUTS therapies and penile implant surgery.
History of urethral obstruction due to stricture, valves, sclerosis, or tumor.
Current neurologic disease or condition associated with neurogenic bladder (for example, Parkinson's disease, multiple sclerosis).
History of cardiac conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study.
History of angina requiring treatment with nitrates.
Prostate Specific Antigen (PSA) greater than 10 nanogram/milliliter (ng/ml) at Visit 1.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00386009). 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.