Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborators:
Ramathibodi Hospital
Siriraj Hospital
Information provided by (Responsible Party):
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT00421460
First received: January 11, 2007
Last updated: May 14, 2012
Last verified: May 2012

January 11, 2007
May 14, 2012
January 2007
January 2011   (final data collection date for primary outcome measure)
Response of treatment for 4 injections at 1 year; score on an IIEF-5 [ Time Frame: 4 injections at 1 year for each subject, at 12,30,46 weeks. ] [ Designated as safety issue: Yes ]
  • Response of treatment for 4 injections at 1 year; score on an IIEF-5
  • at 12,30,46 weeks.
Complete list of historical versions of study NCT00421460 on ClinicalTrials.gov Archive Site
Testosterone level [ Time Frame: at 6,12,18,36,46 weeks ] [ Designated as safety issue: Yes ]
  • The levels of total and free testosterone;determination
  • at 6,12,18,36,46 weeks.
Not Provided
Not Provided
 
The Therapy of Nebido as Mono or in Combination With PDE-5 Inhibitors in Hypogonadal Patients With Erectile Dysfunction
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

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.

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypogonadism
  • Erectile Dysfunction
Drug: Testosterone Undecanoate,1000mg
duration for 4 injections
Other Name: Nebido 1000 mg
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
May 2011
January 2011   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00421460
TH 023101
No
Chulalongkorn University
Chulalongkorn University
  • Ramathibodi Hospital
  • Siriraj Hospital
Principal Investigator: Apichat Kongkanand, Professor King Chulalongkorn Memmorial Hospital
Chulalongkorn University
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP