A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to investigate the efficacy and safety of once daily tadalafil when taken with finasteride as a treatment for men with signs and symptoms of Benign Prostatic Hyperplasia and demonstrable prostate enlargement.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Finasteride; Tadalafil

Criteria

Inclusion Criteria:

• Have not taken the following treatments within the indicated duration and agree not to use at any time during the study:

• All other Benign Prostatic Hyperplasia (BPH) therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.

• Overactive bladder therapy (including antimuscarinics) for at least 4 weeks prior to receiving study medication.

• Erectile Dysfunction therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.

• Finasteride or dutasteride use at any time.

• Have bladder outlet obstruction as defined by a urinary peak flow rate (Qmax) of greater than or equal to 4 and less than or equal to 15 milliliters (mL)/second before receiving study drug.

• Have prostate enlargement measured by ultrasound at screening.

Exclusion Criteria:

• Have prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer [Prostate-specific antigen (PSA) greater than 10 nanograms/milliliter (ng/mL) at the start of study].

• 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 had a stroke or a significant injury to brain or spinal cord.

• Have scheduled or planned surgery during the course of the study.