The Therapy of Nebido as Mono or in Combination With PDE-5 Inhibitors in Hypogonadal Patients With Erectile Dysfunction

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate the response of a treatment with testosterone undecanoate and determine the levels of total and free testosterone in hypogonadal patients with erectile dysfunction.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chulalongkorn University
• Collaborators: Ramathibodi Hospital; Siriraj Hospital
• Treatments: Methyltestosterone; Phosphodiesterase 5 Inhibitors; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

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.