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

Lilly

Status and phase: Completed; Phase 3; Phase 2

Conditions: Benign Prostatic Hyperplasia

Treatments: Drug: tadalafil; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00384930

H6D-MC-LVHG

9797

Details and patient eligibility

About

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.

Enrollment: 1,058 patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,058 participants in 5 patient groups, including a placebo group

1

Placebo Comparator group

Description:

placebo tablet

Treatment:

Drug: placebo

2

Active Comparator group

Description:

2.5 mg tadalafil tablet

Treatment:

Drug: tadalafil

Drug: tadalafil

Drug: tadalafil

Drug: tadalafil

3

Active Comparator group

Description:

5 mg tadalafil tablet

Treatment:

Drug: tadalafil

Drug: tadalafil

Drug: tadalafil

Drug: tadalafil

4

Active Comparator group

Description:

10 mg tadalafil tablet

Treatment:

Drug: tadalafil

Drug: tadalafil

Drug: tadalafil

Drug: tadalafil

5

Active Comparator group

Description:

20 mg tadalafil tablet

Treatment:

Drug: tadalafil

Drug: tadalafil

Drug: tadalafil

Drug: tadalafil