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

Recruiting in Palo Alto (17 mi)

+64 other locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eli Lilly and Company

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

Inclusion Criteria

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.

Treatment Details

Interventions

• Finasteride (5-alpha Reductase Inhibitor)
• Placebo (Drug)
• Tadalafil (Phosphodiesterase Type 5 Inhibitor)

Participant Groups

Group I: Tadalafil Experimental Treatment 2 Interventions

Group II: Placebo Placebo Group 2 Interventions

Finasteride is already approved in Canada, Japan for the following indications:

Approved in Canada as Finasteride for:

• Benign prostatic hyperplasia
• Male pattern baldness

Approved in Japan as Finasteride for:

• Benign prostatic hyperplasia
• Male pattern baldness

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University