Clinical trial: A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone Levels, Sex Drive and Energy (NCT01816295)

Eligibility criteria:
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
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 19-year-old male came to clinic with some sexual concern.  He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates.  On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH.

Patient description (patient's own words): I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels.

Does the patient match the trial criteria? 1