A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED)

Lilly

Status and phase: Completed; Phase 3

Conditions: Erectile Dysfunction; Benign Prostate Hyperplasia

Treatments: Drug: 0.2 mg Tamsulosin; Drug: Placebo; Drug: 5 mg Tadalafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT01937871

14393

H6D-MC-LVJE (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to see whether tadalafil can reduce the signs and symptoms in men with Erectile Dysfunction (ED) and Benign Prostatic Hyperplasia-Lower Urinary Tract Symptoms (BPH-LUTS) and improve their quality of life.

Enrollment: 909 patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Present with a history of ED and signs and symptoms of BPH.
• Are sexually active with an adult female partner, and expect to remain sexually active with the same adult female partner for the duration of the study.

Main Exclusion Criteria:

• Current treatment with nitrates.
• Prostate-specific antigen (PSA) greater than 10.0 nanogram (ng)/mL at 1st screening.
• PSA greater than or equal to 4.0 to less than or equal to 10.0 ng/mL at 1st screening if prostate malignancy has not been ruled out to the satisfaction of a urologist
• Suffering from other urinary disease like cancer, or infection
• Serious cardiovascular disease
• History of significant renal insufficiency

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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909 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.

Treatment:

Drug: Placebo

5 mg Tadalafil

Experimental group

Description:

Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period. Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period

Treatment:

Drug: 5 mg Tadalafil

Drug: Placebo

0.2 mg Tamsulosin

Other group

Description:

Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period. Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period

Treatment:

Drug: 0.2 mg Tamsulosin

Drug: Placebo