Pilot Study Investigating Safety and Efficacy of Tadalafil as Treatment for Benign Prostatic Hyperplasia (BPH) in Asian Men

Eli Lilly and Company151 enrolled

Overview

The primary purpose of this clinical trial is to evaluate the change in the International Prostate Symptom Score (IPSS) total score from the beginning of the study to the end of the study for subjects randomized to tadalafil 5mg once a day dosing and placebo once a day dosing for 12 weeks of treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

151

Conditions

Benign Prostatic Hyperplasia

Interventions

TadalafilDRUG

5 mg once a day

PlaceboDRUG

once a day

TamsulosinDRUG

0.2 mg once a day

Eligibility

Sex: MALEMin age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have Benign Prostatic Hyperplasia - Lower Urinary Tract Symptoms (BPH-LUTS) for at least 6 months prior to Visit 1. * Agree not to use any other approved or experimental treatments for erectile dysfunction or BPH-LUTS during the study. * Have not taken Finasteride therapy for at least 3 months prior to Visit 2. * Have not taken Dutasteride therapy for at least 6 months prior to Visit 2. * Have an International Prostate Symptom Score (IPSS) total score greater than or equal to 13 at Visit 2. Exclusion Criteria: * Prostate Specific Antigen (PSA) greater than 10.0 nanograms per milliliter (ng/mL) at Visit 1. * Bladder Post Void Residual (PVR) greater than or equal to 300 mL by ultrasound at Visit 1. * History of pelvic surgery, prostatectomy, radiotherapy, penile implant surgery, lower urinary tract malignancy or trauma. * Urinary tract infection or inflammation or current antibiotic therapy for urinary tract infection at Visit 1. * Glycosylated hemoglobin (HbA1c) greater than 9% at Visit 1.

Locations (5)

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.

Jeonju, South Korea

Kwangju, South Korea

Outcomes

Primary Outcomes

Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score

The IPSS Total Score is obtained by combining the scores of the responses to 1 through 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.

Time frame: baseline, 12 weeks

Secondary Outcomes

Change From Baseline to 4 Week and 8 Week Endpoints in International Prostate Symptom Score (IPSS) Total Score

Time frame: baseline, 4 and 8 weeks

Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore

The IPSS storage (irritative) subscore is defined as sum of scores for Questions 2, 4, and 7 of the IPSS. If scores for any of these questions are missing for a visit, the IPSS storage subscore will be reported as missing for that visit. Subscore totals range from 0 to 15; higher scores are indicative of greater irritation.

Time frame: baseline, 4, 8, and 12 weeks

Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore

The IPSS voiding (obstructive) subscore is defined as sum of scores for Questions 1, 3, 5, and 6 of the IPSS. If scores for any of these questions are missing for a visit, the IPSS voiding subscore will be reported as missing for that visit. Subscore totals range from 0 to 20; higher scores are indicative of greater obstruction.

Time frame: baseline, 4, 8, and 12 weeks

Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore

Data from ClinicalTrials.gov

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Kyunggi-Do, South Korea

Pusan, South Korea

Seoul, South Korea

IPSS Question 7 is used to assess the frequency of nocturia. Scores range from 0 (low frequency of nocturia) to 5 (high frequency of nocturia).

Time frame: baseline, 4, 8, and 12 weeks

Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BPH-II)

The BPH-BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range of 0 to 13; higher scores represent increased perceived impact of BPH-LUTS on overall health. If scores for any component question were missing for a visit, BPH-BII was reported as missing for that visit.

Time frame: baseline, 12 weeks

Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies

A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Scores were combined to provide number of participants who indicated they were "worse" (scores of 5, 6, or 7), "no change" (score of 4), or "better" (scores of 1, 2, or 3).

Time frame: 12 weeks

Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies

Measures clinician's perception of patient improvement of illness at the time of assessment compared with start of treatment. Scores range from 1 (very much better) to 7 (very much worse). Scores were combined to provide number of participants whose clinician indicated they were "worse" (scores of 5, 6, or 7), "no change" (score of 4), or "better" (scores of 1, 2, or 3).

Time frame: 12 weeks

Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary

Patient-completed diary that measures daytime frequency (waking voids) and nocturia (sleeping voids). Average number of waking voids per week, average number of sleeping voids per week, and average number of total voids (sleeping+waking) per week are reported.

Time frame: baseline, 12 weeks

Change From Baseline to 12 Week Endpoint in Total Urinary Incontinence Episodes Per Week Based on Median as Reported in Patient Voiding Dribble Diary

A patient-completed diary that measures urinary incontinence (UI) (leaks). Number of UI leaks per week are reported.

Time frame: baseline, 12 weeks

Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary

A patient-completed diary that measures terminal dribble (dribble in the end of urination) and post-micturition dribble (dribble after urination).

Time frame: baseline, 12 weeks

Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean)

Qmax: defined as the peak urine flow rate (measured in milliliters per second \[mL/second\] using a standard calibrated flowmeter); and Qmean, defined as the mean urine flow rate (measured in mL/second using a standard calibrated flowmeter).

Time frame: baseline, 12 weeks

Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Voided Urine Volume (Vcomp)

Vcomp, defined as the volume of voided urine (measured in milliliters \[mL\]).

Time frame: baseline, 12 weeks