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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

1058 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Benign Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

placebo tablet

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo tablet taken by mouth one a day for twelve weeks

2

2.5 mg tadalafil tablet

Group Type ACTIVE_COMPARATOR

tadalafil

Intervention Type DRUG

2.5 mg tadalafil tablet by mouth once a day for twelve weeks.

3

5 mg tadalafil tablet

Group Type ACTIVE_COMPARATOR

tadalafil

Intervention Type DRUG

5 mg tadalafil tablet by mouth once a day for twelve weeks.

4

10 mg tadalafil tablet

Group Type ACTIVE_COMPARATOR

tadalafil

Intervention Type DRUG

10 mg tadalafil tablet by mouth once a day for twelve weeks.

5

20 mg tadalafil tablet

Group Type ACTIVE_COMPARATOR

tadalafil

Intervention Type DRUG

20 mg tadalafil tablet by mouth once a day for twelve weeks.

Interventions

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tadalafil

2.5 mg tadalafil tablet by mouth once a day for twelve weeks.

Intervention Type DRUG

tadalafil

5 mg tadalafil tablet by mouth once a day for twelve weeks.

Intervention Type DRUG

tadalafil

10 mg tadalafil tablet by mouth once a day for twelve weeks.

Intervention Type DRUG

tadalafil

20 mg tadalafil tablet by mouth once a day for twelve weeks.

Intervention Type DRUG

placebo

Placebo tablet taken by mouth one a day for twelve weeks

Intervention Type DRUG

Other Intervention Names

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LY450190 Cialis IC351 LY450190 Cialis IC351 LY450190 Cialis IC351 LY450190 Cialis IC351

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No