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

Condition(s) targeted: Hypogonadism; Erectile Dysfunction

Intervention: Testosterone undecanoate (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Chulalongkorn University

Official(s) and/or principal investigator(s):
Apichat Kongkanand, Professor, Principal Investigator, Affiliation: King Chulalongkorn Memmorial Hospital

Overall contact:
Apichat Kongkanand, Professor, Phone: +66 02 2564568, Email: kongkanand@yahoo.com

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.

Official title: Phase IV Study of The Therapy of Long-Acting Testosterone Undecanoate,1000mg in 4 ml Oily Solution for i.m.Injection(Nebido) as Mono or in Combination With PDE-5 Inhibitors in Hypogonadal Patients With Erectile Dysfunction

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

Response of treatment for 4 injections at 1 year; score on an IIEF-5

at 12,30,46 weeks.

Secondary outcome:

The levels of total and free testosterone;determination

at 6,12,18,36,46 weeks.

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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.

Apichat Kongkanand, Professor, Phone: +66 02 2564568, Email: kongkanand@yahoo.com

King Chulalongkorn Memorial Hospital, Bangkok 10330, Thailand; Recruiting
Apichat Kongkanand, Prof., Phone: +66 02 2564568, Email: kongkanand@yahoo.com
Apichat Kongkanand, Prof., Principal Investigator

Ramathibodi Hospital, Rajthevee, Bangkok 10400, Thailand; Recruiting
Krisada Ratana-olarn, Professor, Phone: +66 02 2011315, Email: rakrt@mahidol.ac.th
Krisada Ratana-olarn, Professor, Principal Investigator
Sompol Permpongkosol, M.D., Sub-Investigator

Siriraj Hospital, Bangkoknoi, Bangkok 10700, Thailand; Recruiting
Anupan Tantiwong, Assoc Prof., Phone: +66 02 419 7000, Ext: 8010, Email: siatt@mahidol.ac.th
Anupan Tantiwong, Assoc Prof., Principal Investigator

Starting date: January 2007
Ending date: January 2009
Last updated: January 11, 2007