A Study of Tadalafil in Men With Benign Prostatic Hyperplasia Symptoms Who Are Being Treated With Alpha Blockers

Lilly

Status and phase

Completed

Phase 3

Conditions

Benign Prostatic Hyperplasia

Treatments

Drug: Placebo

Drug: Tadalafil

Study type

Interventional

Funder types

Industry

Identifiers

NCT00848081

H6D-MC-LVHS (Other Identifier)

11668

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of tadalafil when given to men who are currently taking a medication called an alpha blocker for the treatment of benign prostatic hyperplasia (BPH) symptoms (such as urinary frequency, urgency, and a feeling that the bladder is not completely emptied after urination).

Enrollment

318 patients

Sex

Male

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Stable on alpha blocker therapy for the treatment of BPH for at least 4 weeks prior to starting the study.
Have not taken the following treatments within the indicated duration and agree not to use at any time during the study:
1. All other Benign Prostatic Hyperplasia therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
2. Overactive Bladder therapy (including antimuscarinics) for at least 4 weeks prior to receiving study medication.
3. Erectile Dysfunction therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
If taking finasteride or dutasteride, must have been taking treatment for at least 6 months.

Exclusion criteria

Currently receiving alpha-blocker therapy for the treatment of hypertension.
History of symptoms associated with orthostasis, including recurrent episodes of dizziness, lightheadedness, loss of consciousness, or syncope.
Treated with nitrates for any cardiac conditions.
Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).
Have problems with kidneys, liver, or nervous system
Have uncontrolled diabetes
Have prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer (PSA greater than 10 ng/ml at the start of study).
Have had a stroke or a significant injury to brain or spinal cord.