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Study to Treat Patients Who Have Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) With Tadalafil Daily

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Lilly

Status and phase

Completed
Phase 3

Conditions

Benign Prostatic Hyperplasia

Treatments

Drug: Placebo
Drug: tadalafil

Study type

Interventional

Funder types

Industry

Identifiers

NCT00827242
H6D-MC-LVHJ (Other Identifier)
10893 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to determine whether an experimental drug known as tadalafil given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia (straining, urinary frequency, feeling like your bladder is still full, etc.)

Enrollment

325 patients

Sex

Male

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Men 45 years of age or older with Benign Prostatic Hyperplasia (BPH) also referred to as BPH-LUTS [lower urinary tract symptoms] based on the disease diagnostic criteria at the start of study.
  • Provide signed informed consent at the start of the study.
  • Have not taken Finasteride therapy for at least 3 months before study drug is dispensed and Dutasteride therapy for at least 6 months before study drug is dispensed.
  • Have not taken other BPH therapy (including herbal preparations), overactive bladder (OAB) therapy, or erectile dysfunction (ED) therapy for at least 4 weeks prior to study drug is dispensed.
  • Agree not to use any other approved or experimental pharmacologic BPH, OAB, or ED treatments anytime during the study
  • Have LUTS with a Total International Prostate Symptom Score (IPSS) greater than or equal to 13 when study drug is dispensed.
  • Have reduced peak urine flow rate when study drug is dispensed (measured by a special toilet equipment).
  • Demonstrate compliance with study drug administration requirements.

Exclusion criteria

  • Treated with nitrates for a cardiac conditions.
  • Have unstable angina or angina that requires treatment.
  • 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 very high or very low blood pressure
  • 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 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

325 participants in 2 patient groups, including a placebo group

Tadalafil
Experimental group
Treatment:
Drug: tadalafil
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

27

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Data sourced from clinicaltrials.gov

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