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

Chulalongkorn University

Status and phase: Completed; Phase 4

Conditions: Erectile Dysfunction; Hypogonadism

Treatments: Drug: Testosterone Undecanoate,1000mg

Study type: Interventional

Funder types: Other

Identifiers

NCT00421460

TH 023101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)