Clinical trial: A Clinical Study to Evaluate the Pharmacokinetics of Testosterone Gel Using an Applicator (NCT01464879)

Eligibility criteria:
Inclusion Criteria:

          -  Ages 18-75

          -  History of hypogonadism

          -  In good health based on medical history, physical examination, and clinical laboratory
             tests

          -  Serum testosterone deficiency

          -  One or more symptom(s) of testosterone deficiency (i.e. fatigue, reduced libido, or
             reduced sexual functioning)

          -  Body mass index (BMI) between 18 and 35 kg/m^2

          -  All screening lab tests within 20% of the normal range (exceptions are liver function
             tests)

          -  HIV, Hepatitis B and C negative

        Exclusion Criteria:

          -  Previous use of FE 999303

          -  Prostate cancer

          -  Breast carcinoma, patient or partner

          -  Palpable prostatic mass(es)

          -  Serum PSA levels ≥3 ng/dL

          -  Chronic use of any drug of abuse

          -  Lower urinary tract obstruction

          -  Clinically significant anemia or renal dysfunction

          -  Cardiovascular disease

          -  Hyperparathyroidism or uncontrolled diabetes

          -  Generalized skin irritation or significant skin disease

          -  Use of any medications that could be considered anabolic (e.g. dehydroepiandrosterone
             (DHEA)) or could interfere with androgen metabolism (e.g. spironolactone,
             5-alfa-reductase-inhibitors, ketoconazole, abiraterone)

          -  Use of estrogens, GnRH agonists/antagonist, antiandrogens, human GH (within previous
             12 months of screening)

          -  Use of testosterone products (within 8 weeks of screening for parenteral products, or
             6 weeks of screening for other preparations)

          -  Sleep apnea

          -  Untreated depression

          -  Subject with a partner who is pregnant or will not use contraception
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years

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? Entailment