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
  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,1000mg
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 [ Time Frame: 4 injections at 1 year for each subject, at 12,30,46 weeks. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Testosterone level [ Time Frame: at 6,12,18,36,46 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: January 2007
Study Completion Date: May 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Testosterone Undecanoate,1000mg
    duration for 4 injections
    Other Name: Nebido 1000 mg
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421460

Locations
Thailand
Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700
Ramathibodi Hospital
Rajthevee, Bangkok, Thailand, 10400
King Chulalongkorn Memorial Hospital
Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Ramathibodi Hospital
Siriraj Hospital
Investigators
Principal Investigator: Apichat Kongkanand, Professor King Chulalongkorn Memmorial Hospital
  More Information

No publications provided

Responsible Party: Chulalongkorn University
ClinicalTrials.gov Identifier: NCT00421460     History of Changes
Other Study ID Numbers: TH 023101
Study First Received: January 11, 2007
Last Updated: May 14, 2012
Health Authority: Thailand: Food and Drug Administration

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

Additional relevant MeSH terms:
Erectile Dysfunction
Hypogonadism
Endocrine System Diseases
Genital Diseases, Male
Gonadal Disorders
Mental Disorders
Sexual and Gender Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Methyltestosterone
Phosphodiesterase 5 Inhibitors
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014