Clinical trial: The Testosterone Trials in Older Men (NCT00799617)

Eligibility criteria:
Inclusion Criteria:

          -  Men greater than or equal to 65 years old

          -  Total serum testosterone concentration < 275 and < 300 ng/dL at 7 -10 AM at each of
             two screening visits

        Exclusion Criteria:

          -  Diagnosed prostate cancer, prostatic intraepithelial neoplasia (PIN), prostate nodule
             or, by the Prostate Cancer Risk Calculator, a >35% risk of having overall prostate
             cancer or >7% risk of having high grade prostate cancer

          -  Severe lower urinary tract symptoms (score of > 19) by the International Prostate
             Symptom Score questionnaire

          -  Hemoglobin <10 g/dL or >16.0 g/dL

          -  Sleep apnea, diagnosed but untreated

          -  Alcohol or substance abuse within the past year (based on self report)

          -  Angina not controlled by treatment

          -  NYHA class III or IV congestive heart failure

          -  Myocardial infarction within the previous 3 months before entry

          -  Stroke within the previous 3 months before entry

          -  Severe pulmonary disease that precludes physical function tests

          -  Serum creatinine >2.2 mg/dL; ALT 3x upper limit of normal; hemoglobin A1c >8.5%, TSH >
             7.5mIU/L

          -  Diagnosis or treatment for cancer within the past 3 years, with the exception of
             nonmelanotic skin cancer

          -  Body mass index (BMI) >37 kg/m2

          -  Mini Mental State Exam (MMSE) Score <24

          -  Major psychiatric disorders, including major depression (PHQ-9 score > 14), mania,
             hypomania, psychosis, schizophrenia or schizoaffective disorders, that are untreated,
             unstable, have resulted in hospitalization or medication change within the previous
             three months, or would result in inability to complete the trial efficacy instruments.
             Subjects whose disorders have been stable while being treated for more than three
             months are eligible.

          -  Use of the following medications within the previous three months:

               -  drugs that affect serum testosterone concentration

               -  rhGH or megestrol acetate

               -  introduction of anti-depressant medication

               -  daily use of prednisone for more than two weeks

          -  Opiate use within the past three months

          -  Skin conditions at the testosterone gel application site, such as ulcer, erosion,
             lichenification, inflammation, or crust, or generalized skin conditions such as
             psoriasis or eczema that might affect testosterone absorption or tolerability of the
             testosterone gel

          -  Known skin intolerance to alcohol or allergy to any of the ingredients of testosterone
             gel

        Participants in the T Trial may also enroll in the Cardiovascular and Bone Trials if it is
        determined that they are eligible based on the specific exclusion criteria.
Male
Accepts Healthy Volunteers
Subject must be at least 65 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? Contradiction