A Study of Tadalafil in Men With Benign Prostatic Hyperplasia Symptoms Who Are Being Treated With Alpha Blockers

Phase 3

Completed

Conditions: Benign Prostatic Hyperplasia

Interventions: Drug: Placebo
Drug: Tadalafil

Registration Number: NCT00848081

Lead Sponsor: Eli Lilly and Company

Brief Summary: The purpose of this study is to evaluate the safety and efficacy of tadalafil when given to men who are currently taking a medication called an alpha blocker for the treatment of benign prostatic hyperplasia (BPH) symptoms (such as urinary frequency, urgency, and a feeling that the bladder is not completely emptied after urination).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 318

Inclusion Criteria

Stable on alpha blocker therapy for the treatment of BPH for at least 4 weeks prior to starting the study.
Have not taken the following treatments within the indicated duration and agree not to use at any time during the study:
1. All other Benign Prostatic Hyperplasia therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
2. Overactive Bladder therapy (including antimuscarinics) for at least 4 weeks prior to receiving study medication.
3. Erectile Dysfunction therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
If taking finasteride or dutasteride, must have been taking treatment for at least 6 months.

Exclusion Criteria

Currently receiving alpha-blocker therapy for the treatment of hypertension.
History of symptoms associated with orthostasis, including recurrent episodes of dizziness, lightheadedness, loss of consciousness, or syncope.
Treated with nitrates for any cardiac conditions.
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 problems with kidneys, liver, or nervous system
Have uncontrolled diabetes
Have prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer (PSA greater than 10 ng/ml at the start of study).
Have had a stroke or a significant injury to brain or spinal cord.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Tadalafil	Tadalafil	-

Primary Outcome Measures

Name	Time	Method
Number of Men With Treatment-emergent Dizziness	Baseline through 12 Weeks	The primary safety measure is the proportion (reported in numbers) of subjects experiencing treatment-emergent dizziness to include the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms of dizziness, dizziness postural, and procedural dizziness. Treatment-emergent dizziness is defined as any of the predefined terms of dizziness that is first reported or worsens in severity after baseline.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Positive Orthostatic Vital Signs Test; Shift From Any Pre-Randomization to Any Post-Randomization Visit	Baseline through 12 Weeks	A positive orthostatic test is defined as at least one of the following 4 criteria being met at any pre-randomization or post-randomization visit: (1) reduction in systolic blood pressure of \>= 20 mmHg from the supine to standing position;(2)reduction in diastolic blood pressure of \>=10 mmHg from the supine to standing position;(3)increase in heart rate of \>= 20 bpm from the supine to standing position; or (4)Unable to remain standing. A negative orthostatic test is defined as none of the above 4 criteria (1, 2, 3, or 4) being met at any pre-randomization or post-randomization visit.
International Prostate Symptom Score (IPSS) Change From Baseline	Baseline, 12 Weeks	Change from baseline to endpoint in IPSS Score. The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Postvoid Residual Volume (PVR) Change From Baseline	Baseline, 12 Weeks	Change from baseline to endpoint in PVR volume. PVR is obtained by measuring with ultrasound the remaining urine in the bladder after urination.
Uroflowmetry (Qmax) Change From Baseline	Baseline, 12 Weeks	Change from baseline to endpoint in Qmax. Qmax is defined as the peak urine flow rate (measured in milliliters per second \[mL/second\] using standard calibrated flowmeter).

Trial Locations

Locations (1): For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Santurce, Puerto Rico