A Study of Tadalafil in Men With Benign Prostatic Hyperplasia

Lilly

Status and phase: Completed; Phase 3

Conditions: Benign Prostatic Hyperplasia (BPH)

Treatments: Drug: Placebo capsule; Drug: Tadalafil 5 mg; Drug: Tamsulosin; Drug: Placebo tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT00970632

H6D-MC-LVID (Other Identifier)

12932

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: 511 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-lower urinary tract symptoms (LUTS) on the disease diagnostic criteria at the start of study.
• Provide signed informed consent at the start of the study.
• Agree not to use any other approved or experimental pharmacologic BPH, overactive bladder (OAB), or erectile dysfunction (ED) treatments anytime during 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), OAB therapy, ED therapy for at least 4 weeks prior to study drug is dispensed.
• Have LUTS with a total International Prostate Symptom Score (IPSS) greater than or equal to 13 when study drug is dispensed.
• Have reduced urine flow (measured by special toilet equipment).
• Demonstrate compliance with study drug administration requirements.

Exclusion criteria

• Treated with nitrates
• 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 certain neurological conditions associated with bladder problems or injuries to brain or spinal cord within a specified time of starting this study.
• Have uncontrolled diabetes.
• Have prostate cancer, are being treated for cancer.
• Have prostate specific antigen (PSA) greater than 10 nanograms per milliliter (ng/mL) at the start of study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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511 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo tablet with tamsulosin dose orally (po) once daily (QD) and placebo capsule with tadalafil dose po QD for 12 weeks

Treatment:

Drug: Placebo capsule

Drug: Placebo tablet

Tadalafil 5 milligram (mg)

Experimental group

Description:

Tadalafil 5 mg tablet po QD and placebo capsule po QD for 12 weeks

Treatment:

Drug: Tadalafil 5 mg

Tamsulosin 0.4 mg

Active Comparator group

Description:

Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks

Treatment:

Drug: Tamsulosin