Clinical trial: A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel (NCT01665599)

Eligibility criteria:
Inclusion Criteria:

          1. Males between 18-75 years of age

          2. Two screening serum testosterone values less than 300 ng/dL

          3. One or more symptoms of testosterone deficiency

        Exclusion Criteria:

          1. Previous use of the investigational product

          2. Use of any investigational product within 30 days prior to screening and during the
             study

          3. BMI less than 18 kg/m^2 or more than 35 kg/m^2

          4. Prostatic mass(es)

          5. Generalized skin irritation or skin disease

          6. Lower urinary tract obstruction

          7. Myocardial infarction or cerebrovascular accident in the last 6 months

          8. Unstable angina or congestive heart failure

          9. Thromboembolic disorders

         10. Sleep apnea

         11. Hyperparathyroidism or uncontrolled diabetes

         12. Untreated moderate to severe depression

         13. History of testicular, prostate, or breast cancer

         14. HIV, Hepatitis B, or Hepatitis C positive

         15. PSA more or equal to 3 ng/mL

         16. Use of any medications that could be considered anabolic

         17. Use of estrogens, Gonadotropin Releasing Hormone agonists/antagonists, antiandrogens,
             or human Growth Hormone

         18. Chronic use of any drug of abuse

         19. Involvement in a sport in which there is a screening for anabolic steroids

         20. Not willing to use adequate contraception during the study

         21. Partner is pregnant and/or breast feeding

         22. Partner has a history of breast, uterine or ovarian cancer
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