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

Lilly

Status and phase

Completed

Phase 3

Conditions

Benign Prostatic Hyperplasia

Enlarged Prostate

Treatments

Drug: Tadalafil

Drug: Finasteride

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01139762

H6D-CR-LVIW (Other Identifier)

13529

Details and patient eligibility

About

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.

Enrollment

696 patients

Sex

Male

Ages

45+ years old

Volunteers

No Healthy Volunteers

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.