Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Parallel Group, Double-blind, Placebo-controlled Flexible Dose Study With and Open-label Extension to Assess the Efficacy and Safety of Viagra (Sildenafil Citrate) in the Treatment of Men With Erectile Dysfunction (ED) and Concomitant Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) in the United States
Brief Summary: The purpose of this study is to determine whether Viagra is effective in treating erectile dysfunction and lower urinary tract symptoms in men affected by both conditions.


Options:
A: Inclusion Criteria

* Present with benign prostatic hyperplasia
* Provide signed informed consent at the screening
* Agree not to use other treatment for Benign Prostatic Hyperplasia, Erectile Dysfunction or Overactive Bladder (including herbal treatments) during the study

Exclusion Criteria

* Have prostatic cancer or are being treated for cancer.
* Any condition that may negatively influence the transrectal ultrasound.
* Are being treated for heart disease with any drug that is called a nitrate (for example, nitroglycerin).
* Any evidence of moderate to severe cardiac disease
* Have had any of the following in the past 90 days: chest pain (called unstable angina or angina) that requires treatment, heart attack also known as myocardial infarction, heart bypass surgery (called coronary artery bypass graft surgery), had a procedure to open up blood vessels in the heart know as angioplasty or stent placement (percutaneous coronary intervention), positive cardiac stress test without effective cardiac intervention.
* Have very high or very low blood pressure.
* Have uncontrolled diabetes.
* Have certain problems with your kidneys, liver, or nervous system.
B: Inclusion Criteria:

* clinical diagnosis of erectile dysfunction (ED)
* lower urinary tract symptoms (LUTS)

Exclusion Criteria:

* previous prostate surgery or invasive intervention for BPH
* active urinary tract disease
C: Inclusion Criteria:

* Have not taken the following treatments within the indicated duration and agree not to use at any time during the study:

  * All other Benign Prostatic Hyperplasia (BPH) therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
  * Overactive bladder therapy (including antimuscarinics) for at least 4 weeks prior to receiving study medication.
  * Erectile Dysfunction therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
  * Finasteride or dutasteride use at any time.
* Have bladder outlet obstruction as defined by a urinary peak flow rate (Qmax) of greater than or equal to 4 and less than or equal to 15 milliliters (mL)/second before receiving study drug.
* Have prostate enlargement measured by ultrasound at screening.

Exclusion Criteria:

* Have prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer \[Prostate-specific antigen (PSA) greater than 10 nanograms/milliliter (ng/mL) at the start of study\].
* 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 had a stroke or a significant injury to brain or spinal cord.
* Have scheduled or planned surgery during the course of the study.
D: 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.

Answer: B