Clinical trial: The Therapy of Nebido as Mono or in Combination With PDE-5 Inhibitors in Hypogonadal Patients With Erectile Dysfunction (NCT00421460)

Eligibility criteria:
Inclusion Criteria:

          1. Patients with ED over 3 months (specify using IIEF score)

          2. Age >= 18 years.

          3. Stable sexual relationship

          4. With low or low normal serum testosterone level (either total or bioavailable
             testosterone) TT <= 4 ng/ml and/or BT <= 1 ng/ml

          5. Aging Male Symptom scale with total score starting at 37 points (must not replace TT <
             4 ng/ml)

          6. Eligible subjects who previously took the oral androgen or PDE5 inhibitor must have
             discontinued their use for 1 month

        Exclusion Criteria:

          1. Contraindication to treatment with Testosterone according to the SPC

          2. Hypersensitivity to the active substances or any of the excipients of Nebido

          3. Diagnosed or suspected carcinoma of the prostate or the male breast cancer

          4. Past or present liver tumors

          5. Acute or chronic hepatic diseases

          6. Severe cardiac, hepatic or renal insufficiency

          7. History of penile implant or significant penile deformity

          8. Diagnosed sleep apnea

          9. Polycythemia (Hematocrit >50%)

         10. Prolactin >25 ng/ml

         11. Organic hypothalamic-pituitary pathology

         12. Any unstable medical, psychiatric or drug/alcohol abuse disorder

         13. Prostate specific antigen (PSA)>= 4 ng/ml

         14. Severe symptomatic benign prostatic hyperplasia (IPSS) sum score >=20)

         15. Diabetes mellitus which is uncontrolled (HbAlc level >10%)

         16. Epilepsy not adequately controlled by treatment

         17. Patients requiring fertility treatment

         18. Hypertension which is not adequately controlled on therapy

         19. Clinically significant chronic hematological disease which may lead to priapism such
             as sickle cell anemia, multiple myeloma or leukemia

         20. Hypersensitivity to PDE-5 inhibitors

         21. Concomitant Medication:

               -  Nitrites or Nitric oxide donors

               -  Anti-androgens

               -  anti-coagulants, with the exception of anti-platelet agents

               -  Any of potent inhibitors of cytochrome P-450 3A4:such as HIV protease inhibitors
                  (Ritonavir or Indinavir); Anti-mycotic agent (Itraconazole and
                  Ketoconazole)-topical application allowed; or Erythromycin.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 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? Entailment