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The Therapy of Nebido as Mono or in Combination With PDE-5 Inhibitors in Hypogonadal Patients With Erectile Dysfunction
This study is currently recruiting participants.
Verified by Chulalongkorn University, January 2007
First Received: January 11, 2007   No Changes Posted
Sponsor: Chulalongkorn University
Collaborators: Ramathibodi Hospital
Siriraj Hospital
Information provided by: Chulalongkorn University
ClinicalTrials.gov Identifier: NCT00421460
  Purpose

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.


Condition Intervention Phase
Hypogonadism
Erectile Dysfunction
Drug: Testosterone undecanoate
Phase IV

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

Resource links provided by NLM:


Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • Response of treatment for 4 injections at 1 year; score on an IIEF-5
  • at 12,30,46 weeks.

Secondary Outcome Measures:
  • The levels of total and free testosterone;determination
  • at 6,12,18,36,46 weeks.

Estimated Enrollment: 30
Study Start Date: January 2007
Estimated Study Completion Date: January 2009
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00421460

Contacts
Contact: Apichat Kongkanand, Professor +66 02 2564568 kongkanand@yahoo.com

Locations
Thailand
King Chulalongkorn Memorial Hospital Recruiting
Bangkok, Thailand, 10330
Contact: Apichat Kongkanand, Prof.     +66 02 2564568     kongkanand@yahoo.com    
Principal Investigator: Apichat Kongkanand, Prof.            
Thailand, Bangkok
Ramathibodi Hospital Recruiting
Rajthevee, Bangkok, Thailand, 10400
Contact: Krisada Ratana-olarn, Professor     +66 02 2011315     rakrt@mahidol.ac.th    
Principal Investigator: Krisada Ratana-olarn, Professor            
Sub-Investigator: Sompol Permpongkosol, M.D.            
Siriraj Hospital Recruiting
Bangkoknoi, Bangkok, Thailand, 10700
Contact: Anupan Tantiwong, Assoc Prof.     +66 02 419 7000 ext 8010     siatt@mahidol.ac.th    
Principal Investigator: Anupan Tantiwong, Assoc Prof.            
Sponsors and Collaborators
Chulalongkorn University
Ramathibodi Hospital
Siriraj Hospital
Investigators
Principal Investigator: Apichat Kongkanand, Professor King Chulalongkorn Memmorial Hospital
  More Information

No publications provided

Study ID Numbers: TH 023101
Study First Received: January 11, 2007
Last Updated: January 11, 2007
ClinicalTrials.gov Identifier: NCT00421460     History of Changes
Health Authority: Thailand: Thai Food and Drug Administration, Ministry of Public Health

Keywords provided by Chulalongkorn University:
Nebido in hypogonadism with erectile dysfunction

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Gonadal Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Methyltestosterone
Genital Diseases, Male
Hormones
Sexual and Gender Disorders
Pharmacologic Actions
Testosterone 17 beta-cypionate
Anabolic Agents
Testosterone
Hypogonadism
Sexual Dysfunction, Physiological
Mental Disorders
Therapeutic Uses
Erectile Dysfunction
Androgens

ClinicalTrials.gov processed this record on February 08, 2010