Clinical trial: Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate (NCT00555087)

Eligibility criteria:
Inclusion Criteria:

          -  Patients older than 18 years old and younger than 70 years.

          -  To have diagnosis of erectile dysfunction by IIEF. Qualification less than 46 points
             and/or GAQ with Answer "NO".

          -  Patients with Inform consent letter signed.

          -  Patients without any therapy with other type of testosterone, gonadotrophines and/or
             PDE-5 in the previous 4 weeks of their inclusion at the study.

          -  Diagnosis of hypogonadism according to the criteria:

          -  Testosterone dosage lower than 12 nmol/L

          -  Free testosterone shall be below 180 pmol/L o 52 pg/mL

        Exclusion Criteria:

          -  People less than 18 years old and older than 70 years.

          -  Patients with history of or with known or suspected sleep apnea.

          -  Patients who participate in other study protocols

          -  Known or suspected active systemic infection.

          -  Patients with HIV + and/ or known HTLV+.

          -  Patients with hyperprolactinemia

          -  Patients with known or suspected coagulopathies

          -  Patients with Klinefelter

          -  Known or suspected psychiatric illness.

          -  Patients who have received prior therapy with some kind of testosterone in the last 4
             months or a PDE-5 inhibitor in the last month.

          -  Patients with contraindications for the use of PDE-5 inhibitors

          -  Patients having a diagnosis of erectile dysfunction but with total and/ or free
             testosterone levels within the physiological range.

          -  Patients with APE ≥ 2.5 ng/ml in younger than 60 years, or > de 3 ng/ml in older than
             60 years.

          -  Abnormal prostate findings during the digital rectal examination (that is to say,
             irregularities, hard consistency when examined).

          -  Concomitant malignant diseases or history of prostate cancer
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 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? Entailment