Erectile Dysfunction, Hypogonadism
Conditions
Keywords
Nebido in hypogonadism with erectile dysfunction
Brief 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.
Detailed description
Hypogonadism is a pathophysiologic and clinical factor in a substantial number of patients with ED,and data indicate that a threshold level of testosterone is necessary for normal erectile function.Testosterone therapy is clearly indicated in hypogonadal patients and is beneficial in other patients with ED and hypogonadism.However,testosterone efficacy as monotherapy for ED could be limited,and combination therapy with testosterone and other ED treatments,such as PDE-5 inhibitors may be valuable in certain subpopulations of patients.
Interventions
DRUGTestosterone Undecanoate,1000mg
duration for 4 injections
Sponsors
Ramathibodi Hospital
Siriraj Hospital
Chulalongkorn University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response of treatment for 4 injections at 1 year; score on an IIEF-5 | 4 injections at 1 year for each subject, at 12,30,46 weeks. |
Secondary
| Measure | Time frame |
|---|---|
| Testosterone level | at 6,12,18,36,46 weeks |
Countries
Thailand
Outcome results
None listed