A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone Levels, Sex Drive and Energy

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