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

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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

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

Trial contacts and locations

14

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Data sourced from clinicaltrials.gov

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