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

Erectile Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00421460
• Other study ID #: TH 023101
• Status: Completed
• Phase: Phase 4
• First received: January 11, 2007
• Last updated: May 14, 2012
• Start date: January 2007
• Est. completion date: May 2011

Study information

• Verified date: May 2012
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction
• Hypogonadism

Intervention

Drug:
• Testosterone Undecanoate,1000mg
duration for 4 injections

Locations

Country	Name	City	State
Thailand	King Chulalongkorn Memorial Hospital	Bangkok
Thailand	Siriraj Hospital	Bangkoknoi	Bangkok
Thailand	Ramathibodi Hospital	Rajthevee	Bangkok

Sponsors (3)

Lead Sponsor	Collaborator
Chulalongkorn University	Ramathibodi Hospital, Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	Testosterone level		at 6,12,18,36,46 weeks	Yes