Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
Brief Summary: The purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.


Options:
A: Inclusion Criteria:

* Men between 45 and 80 years age
* Participants with low serum testosterone concentrations (\< 300 ng/dL) who exhibit at least one sign or symptom of hypogonadism and have evidence of cardiovascular (CV) disease or are at an increased risk for CV disease.

Exclusion Criteria:

* Participants with congenital or acquired hypogonadism for whom long-term therapy with placebo would not be medically appropriate
* Participants with prostate specific antigen (PSA) \> 3.0 ng/mL (or 1.5 if on 5-alpha reductase inhibitors)
* Participants who have been treated with testosterone in the past 6 months and for whom testosterone therapy is contraindicated
* Confirmed testosterone \< 100 ng/dL
* Body Mass Index (BMI) \> 50
* Hemoglobin A1c (HbA1C) \> 11%
* Hematocrit (Hct) \> 50%
* Estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min
* History of deep vein thrombosis or pulmonary embolism or prostate cancer or heart failure (Class III and IV).
B: Inclusion Criteria:

* Type 2 diabetes
* Testosterone less than 10 nmol/L

Exclusion Criteria:

* Contraindication to
* Testosterone or
* IM injection
C: Inclusion Criteria:

* Serum testosterone of less than or equal to 300 ng/dL on two occasions within one week (may wash out from previous oral, topical or buccal testosterone therapy)

Exclusion Criteria:

* Significant intercurrent disease of any type, in particular liver, kidney, uncontrolled or poorly controlled heart disease, or psychiatric illness
* Recent history of stroke, not including transient ischemic attack
* Untreated, sever obstructive sleep apnea.
* Hematocrit \<35% or \>48
* Serum transaminases \>2 times upper limit of normal, serum bilirubin \> 2.0 mg/dL and serum creatinine \> 2.0 mgk/dL
* BMI \> or equal to 36
* Stable doses of lipid-lowering medication for less than 3 months
* Stable doses of oral medication for diabetes for less than 2 months
* Abnormal prostate DRE \[palpable nodule(s)\], elevated PSA (\>4 ng/mL), IPSS score \> or equal to 19 points.
* History of breast cancer
* Use of dietary supplement saw palmetto or phytoestrogens and use of any dietary supplements that may increase serum testosterone within previous 4 weeks
* Known malabsorption syndrome and/or current treatment with oral lipase inhibitors
* History of abuse of alcohol or any drug substance within the previous 2 years
* Current use of antiandrogens, estrogens, oral CYP3A4 inducers or inhibitors, or long-acting opioid analgesics
* Receipt of any drug as part of a research study within 30 days of initial dose administration in this study.
* Blood donation within the 12 week period before the initial study dose.
D: Inclusion Criteria:

* Age 60 years or greater
* Hypogonadism, Testosterone 100-400 ng/dl or Free Testosterone \< 50 pg/ml
* Generally good health
* At least 8 years of primary school education
* Able to pass screening test for dementia
* Able to give informed consent

Exclusion Criteria:

* Testosterone level \< 100 ng/dl (these individuals will be referred for evaluation of severe hypogonadism)
* Use of testosterone or other androgens \[dehydroepiandrosterone (DHEA), Androstenedione\] in last year
* Use of growth hormone in the last year
* Current alcohol of drug dependence \[Alcohol Use Disorders Identification Test (AUDIT) Score \> 8\]
* Diseases known to affect gonadal function
* Medications known to affect gonadal function eg. anticonvulsants, glucocorticoids such as prednisone
* Prostate cancer, breast cancer
* Any cancer that may limit life expectancy to less than 5 years
* Limiting neuromuscular, joint or bone disease
* History of stroke with residual neurologic deficit
* Neurologic condition that would impair cognitive function including:

epilepsy, multiple sclerosis, human immunodeficiency virus (HIV), Parkinson's disease, stroke

* Psychiatric disorder in the last year meeting Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSMIV) Axis 1 criteria
* Use of psychotropic medicine for at least 6 months
* Dementia as assessed by (Telephone Interview for Cognitive Status modified score less than 31)
* Severe symptoms of benign prostatic hyperplasia (BPH) (American Urological Association symptom index score greater than 21)
* Prostate nodule or induration of digital rectal exam (DRE)
* Prostate specific antigen (PSA) greater than 4 unless participant has had a negative transrectal biopsy within last 3 months
* Limiting heart disease in including New York (NY) Class III or IV - congestive heart failure, unstable angina, or myocardial infarction (MI) in last 3 months
* Liver function tests \[aspartate aminotransferase (AST) and alanine aminotransferase(ALT)\] greater than 3 times the upper limit of the reference range
* Serum creatinine (Cr) greater than 2.5 mg/dl
* Hematocrit greater than 48%
* Hemoglobin (Hb)A1c greater than 9.0%
* Untreated thyroid disease
* Uncontrolled hypertension (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg)
* Body mass index (BMI greater than 35 kg/m2)
* Untreated severe obstructive sleep apnea
* Development of electrocardiogram (EKG) changes consistent with myocardial ischemia or changes in blood pressure during cardiopulmonary exercise testing will be excluded from testing of muscle strength and physical function.

Answer: C