Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Parallel Study With an Open-Label Extension to Assess the Impact of Testosterone Solution on Total Testosterone, Sex Drive and Energy in Hypogonadal Men
Brief Summary: The main purpose of this study is to evaluate if testosterone solution can raise testosterone hormone levels into the normal range, and also improve levels of sexual arousal, interest and drive and/or energy level, in men with low testosterone and decreased sexual arousal, interest and drive and/or decreased energy. The study will last about 16 weeks, followed by an optional 24 week open label treatment phase to investigate the long term safety of testosterone solution.


Options:
A: Inclusion Criteria:

* Total testosterone level \<300 nanogram per deciliter (ng/dL) \[10.4 nanomole per Liter (nmol/L)\] at each of 2 screening visits
* At least 1 symptom of testosterone deficiency, which must include decreased energy or decreased sexual drive
* Prostate Specific Antigen (PSA) \<4 nanogram per milliliter (ng/ml) at screening

Exclusion Criteria:

* Sexual partner who is or becomes pregnant at any time during the study
* Use of long-acting intramuscular (IM) testosterone undecanoate or testosterone pellets in the 6-month period prior to screening
* Body Mass Index (BMI) \>37 kilogram per square meter (kg/m\^2) at screening
* Severe lower urinary tract symptoms and/or significant prostate enlargement
* Prolactin lab test result of \>30 ng/mL at screening
* Hemoglobin A1c (HbA1c) \>11% at screening
* Hematocrit ≥50% (\>54% at elevated altitude) at screening
* Current use of any medications, herbal, and/or nutritional supplements that can interfere with testosterone
* Dermatologic condition in underarm area that might interfere with testosterone absorption (for example, eczema) or be exacerbated by topical testosterone replacement therapy
* Currently receiving treatment with cancer chemotherapy or antiandrogens
* Chronic use of systemic glucocorticoids (use for \>14 days within the 3 months prior to screening); use of non-testosterone anabolic steroids within 12 months prior to screening
* Competitive athletes involved in a sport in which they may be screened for anabolic steroids
* History of use of estrogenizing agents within 12 months prior to screening
* History of luteinizing hormone-releasing hormone antagonist or agonist treatment in the last 6 months prior to screening
* History of clomiphene or other anti-estrogen treatment in the 3 months prior to screening
* Use of finasteride within 3 months prior to screening, or use of dutasteride within 6 months prior to screening
* Current use of warfarin or phenprocoumon
* History of frequent opioid use: \>1 time/week during any week within 30 days prior to screening
* Current use of dopamine receptor agonists (cabergoline, pergolide, bromocriptine)
* Have a history of significant central nervous system injuries or disease (including stroke, spinal cord injury, or multiple sclerosis) within 6 months prior to screening
* Systolic blood pressure \>170 or \<90 millimeter of mercury (mm Hg) or diastolic blood pressure \>100 or \<50 mm Hg at screening or a history of malignant hypertension
* History of unstable angina as defined by Braunwald Classification of Unstable Angina or angina occurring during sexual intercourse in the last 6 months
* History of any of the following coronary conditions within 90 days of screening: myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention (angioplasty or stent placement)
* Have any supraventricular arrhythmia with an uncontrolled ventricular response \[mean heart rate \>100 beats per minute (bpm)\] at rest, or have any history of spontaneous or induced sustained ventricular tachycardia (heart rate \>100 bpm for ≥30 seconds), or use of an automatic internal cardioverter-defibrillator
* Have a history of sudden cardiac arrest
* Exhibit any evidence of congestive heart failure \[New York Heart Association (NYHA) Class 2 or above\], within 6 months prior to screening
* Have had a new, significant cardiac conduction defect within 90 days prior to screening
* Clinical suspicion (or history) of prostate cancer during digital rectal examination at screening
* Known or suspected breast cancer (or history of breast cancer) or other active cancer (with the exception of nonmelanotic skin cancer)
* Exhibit evidence of severe renal impairment \[creatinine clearance \<30 milliliter per minute (mL/min) as determined by the Cockcroft-Gault formula\] at screening
* Exhibit a history of severe liver disease or clinical evidence of hepatic impairment at screening
* Have a history of human immunodeficiency virus (HIV) infection
* Severe sleep apnea
* Untreated hypothyroidism, hypercortisolism or other significant endocrinopathy (other than hypogonadism) that contributes to symptoms of low energy or fatigue
B: Inclusion Criteria:

* Community dwelling, ages 65 and older
* Self-reported difficulty in climbing 10 steps without resting, or difficulty in walking 2 or 3 blocks outside on level ground
* A score of 4 to 9 on the Short Physical Performance Battery (mild to moderate physical impairment)
* Total serum testosterone level (TT) \< 350 ng/dL and \> 100 ng/dL
* Without dementia (Mini-Mental State Examination \[MMSE\] score \> 24)

Exclusion Criteria:

* Use of testosterone, anabolic steroids, dehydroepiandrosterone (DHEA), androstenedione or recombinant growth hormone (rGH) in the past year
* Alcohol or drug abuse
* Use of anti-convulsants or glucocorticoids (equivalent to prednisone \> 20 mg/day)
* Prostate cancer, breast cancer or other cancers with life expectancy \< 5 years
* Limiting neuromuscular, joint or bone disease, or history of stroke with residual neurological problems
* Any neurological condition that would impact cognitive functioning including:

  * epilepsy
  * multiple sclerosis
  * HIV
  * Parkinson's disease
  * stroke
  * other focal lesion
* Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Axis I psychiatric disorder in past year or use of psychotropic medications in 6 months
* Abnormal prostate examination; PSA \> 4 ng/mL; or BPH symptom score \> 21
* Unstable angina, New York (NY) class III or IV congestive heart failure or myocardial infarction within 3 months of entry
* Abnormal laboratory values (at discretion of principal investigator)
* Untreated thyroid disease; systolic blood pressure \> 160 or diastolic \> 100 mm Hg
* Body mass index \> 40 kg/m2
* Untreated severe obstructive sleep apnea
C: Inclusion Criteria:

* Men, 40-70 years of age, in a stable relationship, with mild to moderate erectile dysfunction for at least 6 months; defined as an IIEF-EF domain score between 11 and 25 (mild to moderate ED)
* Neutral or extremely dissatisfied with one's sex life
* Presence of androgen deficiency defined as serum total testosterone level less than 300 ng/dL (measured by LC-MS/MS) and/or free testosterone level (measured by equilibrium dialysis) less than 50 pg/ml.
* Able to understand the nature of the study and provide written, informed consent

Exclusion Criteria:

* Contraindication for use of testosterone, e.g., history of prostate or breast cancer
* benign prostatic hyperplasia with AUA/IPSS symptom scores of 21 or greater
* erythrocytosis (hematocrit \>50% at baseline)
* untreated, severe sleep apnea
* serum PSA levels \>4 ug/L will be excluded unless they have had a urologic evaluation in the past three months to exclude prostate cancer.
* Contraindication for use of sildenafil, e.g., symptomatic coronary artery disease taking long-acting or short-acting nitrate drugs on a regular basis.
* Symptomatic postural hypotension
* Congestive heart failure with class III or IV symptoms
* History of myocardial infarction or stroke within the past six months
* Primary diagnosis of another sexual disorder such as premature ejaculation
* AST, ALT, alkaline phosphatase elevation greater than three times the upper limit of normal, creatinine greater than 2 mg/dL.
* Currently taking testosterone or oral androgen precursors; unless willing to discontinue their use for 4 weeks (oral precursors or transdermal testosterone patch or gel) or 6 weeks (if injectable testosterone) before the initial screen visit.
* Currently taking medications that affect androgen metabolism, action, or clearance (dilantin, phenobarbital, aldactone, flutamide, finasteride).
* Uncontrolled diabetes mellitus or diabetes mellitus, e.g., if their baseline hemoglobin A1C is less than 8.5%.
* Structural abnormalities of the penis, including Peyronie's disease, will be excluded.
* Men who are taking medications for erectile dysfunction, including sildenafil, must stop using these medications for at least 4 weeks before starting Visit 2.
* DSM-IV criteria for an Axis I psychiatric disorder within the past year, including depression; use of psychotropic medication for at least six months, or dementia is also an exclusion.
D: Inclusion Criteria:

* Subjects were at least 50 years of age
* A body mass index (BMI) between 18 and 34 kg/m\^2
* Symptoms of androgen deficiency (as indicated by a positive Androgen Deficiency in Aging Males (ADAM) questionnaire)
* Calculated free testosterone measurement of \<0.26 nmol/L in the morning

Exclusion Criteria:

* History or current diagnosis of breast or prostate cancer
* any clinically significant abnormal finding on physical examination including the prostate
* Clinical symptoms of obstructive benign prostate hyperplasia (International Prostate Symptom Score (IPSS) \>14)
* Prostate specific antigen (PSA) level \> 4 ng/mL at screening
* Cause of androgen deficiency other than aging, e.g. 'classical' diagnosis of primary or secondary hypogonadism
* Hyperprolactinaemia or treatment with prolactin-lowering drugs
* History of known chronic polycythemia and/or hematocrit \>50% at screening
* History or presence of severe sleep apnea
* Unstable or untreated endocrine disorders
* History or presence of clinically significant depression or other psychiatric disorder or any clinically relevant cardiovascular, cerebrovascular, endocrine, hepatic, renal or hematological disease, thromboembolism/thrombosis etc. which, in the opinion of the investigator, might compromise the subject's participation in the trial
* Use of medication that would interfere with the efficacy and safety objectives of the trial

Answer: A