Clinical trial: Effect of Testosterone in Men With Erectile Dysfunction (NCT00512707)

Eligibility criteria:
Inclusion Criteria:

          -  Men, 40-70 years of age, in a stable relationship, with mild to moderate erectile
             dysfunction for at least 6 months; defined as an IIEF-EF domain score between 11 and
             25 (mild to moderate ED)

          -  Neutral or extremely dissatisfied with one's sex life

          -  Presence of androgen deficiency defined as serum total testosterone level less than
             300 ng/dL (measured by LC-MS/MS) and/or free testosterone level (measured by
             equilibrium dialysis) less than 50 pg/ml.

          -  Able to understand the nature of the study and provide written, informed consent

        Exclusion Criteria:

          -  Contraindication for use of testosterone, e.g., history of prostate or breast cancer

          -  benign prostatic hyperplasia with AUA/IPSS symptom scores of 21 or greater

          -  erythrocytosis (hematocrit >50% at baseline)

          -  untreated, severe sleep apnea

          -  serum PSA levels >4 ug/L will be excluded unless they have had a urologic evaluation
             in the past three months to exclude prostate cancer.

          -  Contraindication for use of sildenafil, e.g., symptomatic coronary artery disease
             taking long-acting or short-acting nitrate drugs on a regular basis.

          -  Symptomatic postural hypotension

          -  Congestive heart failure with class III or IV symptoms

          -  History of myocardial infarction or stroke within the past six months

          -  Primary diagnosis of another sexual disorder such as premature ejaculation

          -  AST, ALT, alkaline phosphatase elevation greater than three times the upper limit of
             normal, creatinine greater than 2 mg/dL.

          -  Currently taking testosterone or oral androgen precursors; unless willing to
             discontinue their use for 4 weeks (oral precursors or transdermal testosterone patch
             or gel) or 6 weeks (if injectable testosterone) before the initial screen visit.

          -  Currently taking medications that affect androgen metabolism, action, or clearance
             (dilantin, phenobarbital, aldactone, flutamide, finasteride).

          -  Uncontrolled diabetes mellitus or diabetes mellitus, e.g., if their baseline
             hemoglobin A1C is less than 8.5%.

          -  Structural abnormalities of the penis, including Peyronie's disease, will be excluded.

          -  Men who are taking medications for erectile dysfunction, including sildenafil, must
             stop using these medications for at least 4 weeks before starting Visit 2.

          -  DSM-IV criteria for an Axis I psychiatric disorder within the past year, including
             depression; use of psychotropic medication for at least six months, or dementia is
             also an exclusion.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 70 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? Contradiction