Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
- Registration Number
- NCT00386009
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 200
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Placebo Placebo 2 Tadalafil tadalafil
- Primary Outcome Measures
Name Time Method Change From Baseline to 12 Week Endpoint in Detrusor Pressure at Peak Urinary Flow Rate (PdetQmax) Baseline and 12 weeks
- Secondary Outcome Measures
Name Time Method Change From Baseline to 12 Week Endpoint in Postvoid Residual Volume (PVRcath) Measured During Free-Flow Studies Baseline and 12 weeks PVRcath is the volume of urine remaining int he bladder after voiding, measured by catheterization.
Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Free-Flow Studies Baseline and 12 weeks Qmax was measured during free-flow tests using a standard calibrated flow meter.
Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Free-Flow Studies Baseline and 12 weeks Qave was measured during free-flow tests using a standard calibrated flow meter.
Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Free-Flow Studies Baseline and 12 weeks Change From Baseline to 12 Week Endpoint in Total Bladder Capacity Measured During Free-Flow Studies Baseline and 12 weeks Total bladder capacity was defined as Vcomp + PVRcath (obtained when the bladder was full).
Change From Baseline to 12 Week Endpoint in Bladder Voiding Efficiency (BVE) Measured During Free-Flow Studies Baseline and 12 weeks Bladder voiding efficiency was defined as (Vcomp/total bladder capacity) X 100 (obtained when the bladder was full).
Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Pressure-Flow Studies Baseline and 12 weeks Qmax was measured duirng pressure-flow tests.
Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Pressure-Flow Studies Baseline and 12 weeks Qave was measured during pressure-flow tests.
Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Pressure-Flow Studies Baseline and 12 weeks Vcomp was defined as the volume of voided urine measured during pressure-flow tests.
Change From Baseline to 12 Week Endpoint in Maximum Detrusor Pressure (Max Pdet) Measured During Pressure-Flow Studies Baseline and 12 weeks Max Pdet was defined as the maximum detrusor pressure observed during voiding.
Change From Baseline to 12 Week Endpoint in Bladder Contractility Index (BCI) Measured During Pressure-Flow Studies Baseline and 12 weeks BCI was derived from the equation PdetQmax + 5Qmax. Scores: \<100 means weak, 100-150 menas normal, \>150 means strong. A decrease means a decrease in contractility of the bladder.
Change From Baseline to 12 Week Endpoint in Bladder Outlet Obstruction Index (BOOI) Measured During Pressure-Flow Studies Baseline and 12 weeks BOOI, formerly known as the Abrams-Griffith number, was derived from the equation PdetQmax - 2Qmax. Scores: \<20 means unobstructed, 20-40 means equivocol, \>40 means obstructed. An increase means worsening of obstruction, a decreased means lessening of obstruction (improvement).
Presence of Involuntary Detrusor Contractions During Bladder Filling Baseline and 12 weeks Change From Baseline to 12 Week Endpoint in Bladder Volume at First Involuntary Detrusor Contraction Baseline and 12 weeks Assessed in participants with involuntary detrusor contractions during the bladder filling at both baseline and endpoint.
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score 12 weeks The IPSS Total Score is obtained by combining the scores of the responses to the 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Clinically Adverse and Statistically Significant Changes From Baseline to 12 Week Endpoint in Laboratory Tests Baseline and 12 weeks Laboratory tests that were statistically significant and clinically adverse would be reported for safety.
Trial Locations
- Locations (1)
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.
🇵🇹Porto, Portugal