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

Phase 2

Completed

Conditions: Benign Prostatic Hyperplasia

Interventions: Drug: placebo
Drug: tadalafil

Registration Number: NCT00384930

Lead Sponsor: Eli Lilly and Company

Brief Summary: This is a randomized, double-blind, placebo-controlled, parallel-design, multinational, 12-week study to compare the efficacy, dose response, and safety of tadalafil once a day versus placebo in men with signs and symptoms of benign prostatic hyperplasia, including lower urinary tract symptoms.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 1058

Inclusion Criteria

Males, 45 years or older, with benign prostatic hyperplasia, including lower urinary tract symptoms for at least 6 months prior to Visit 1 and an International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 2.
Agree not to use approved or experimental benign prostatic hyperplasia or erectile dysfunction treatments anytime during the study
Have not taken finasteride or dutasteride therapy, any other lower urinary tract symptom (LUTS) therapy or phosphodiesterase type 5 (PDE5) inhibitors for specified duration of time prior to Visit 2.
Have a prostate specific antigen (PSA) score within acceptable range defined for study or negative biopsy of the prostate for cancer within 12 months of Visit 1.

Exclusion Criteria

History of urinary retention or lower urinary tract (bladder) stones 6 months before the start of the study
History of bladder outlet obstruction or urethral obstruction due to stricture, valves, sclerosis, or tumor.
History of cardiac conditions including angina requiring certain treatment with nitrates, heart disease or coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study.
Certain neurological conditions associated with bladder problems or injuries to the brain or spinal cord within a specified time before starting the study.
Nitrate use

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	placebo	placebo tablet
2	tadalafil	2.5 mg tadalafil tablet
3	tadalafil	5 mg tadalafil tablet
4	tadalafil	10 mg tadalafil tablet
5	tadalafil	20 mg tadalafil tablet

Primary Outcome Measures

Name	Time	Method
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis	Baseline and 12 weeks	Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.
Change From Baseline to Week 12 in International Prostate Symptom Score (IPSS): Supportive Analysis	Baseline and 12 weeks	Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) (Irritative) Subscore	baseline and 12 weeks	Measures irritative symptoms over the past 4 weeks of the IPSS. IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 1 (few irritative symptoms) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.
Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BII)	baseline and 12 weeks	Measures the impact that symptoms of BPH has on the patients well being. This questionnaire has 4 questions assessing the level of urinary discomfort and it's impact on the patients. Three questions range from 0 (no impact) to 4 (high impact); one question ranges from 0 (low impact) to 4 (high impact). The BII score ranges from 0 to 16.
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore	12 weeks	Measures obstructive symptoms over the past 4 weeks of the IPSS. IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 1 (few obstructive symptoms) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Question 7 (Nocturia)	baseline and 12 weeks	Measures nocturia (the need to get up at night to urinate) over the past 4 weeks. Scores range from 1 (few episodes of nocturia) to 5 (frequent episodes of nocturia).
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index	baseline and 12 weeks	Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).
Number of Participants Who Answer "Yes" to the Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ)	12 weeks	LUTS-GAQ Question asks the participant if the treatment they have been on has improved their uninary symptoms.
Change From Baseline to 12 Week Endpoint in Peak Urinary Flow	baseline and 12 weeks	Measures the maximum flow rate of urine (measured in mL/s). This is a continuous parameter with positive numeric values.
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) EF Domain	baseline and 12 weeks	Measures erectile function over the past 4 weeks on Questions 1-5 and 15 (6 questions) of the International Index of Erecile Function (IIEF) questionnaire. Scores range from 0 (low/no erectile function) to 5 (high erectile function), thus the 6 questions of the IIEF-EF domain range from 0 to 30.

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.
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Greenwood, Indiana, United States