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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00421460
Recruitment Status : Completed
First Posted : January 12, 2007
Last Update Posted : May 15, 2012
Ramathibodi Hospital
Siriraj Hospital
Information provided by (Responsible Party):
Chulalongkorn University

Brief 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.

Condition or disease Intervention/treatment Phase
Hypogonadism Erectile Dysfunction Drug: Testosterone Undecanoate,1000mg Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2007
Actual Primary Completion Date : January 2011
Actual Study Completion Date : May 2011

Intervention Details:
  • Drug: Testosterone Undecanoate,1000mg
    duration for 4 injections
    Other Name: Nebido 1000 mg

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. Testosterone level [ Time Frame: at 6,12,18,36,46 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00421460

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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
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Principal Investigator: Apichat Kongkanand, Professor King Chulalongkorn Memmorial Hospital

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Responsible Party: Chulalongkorn University Identifier: NCT00421460     History of Changes
Other Study ID Numbers: TH 023101
First Posted: January 12, 2007    Key Record Dates
Last Update Posted: May 15, 2012
Last Verified: May 2012
Keywords provided by Chulalongkorn University:
Nebido in hypogonadism with erectile dysfunction
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Gonadal Disorders
Endocrine System Diseases
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Phosphodiesterase 5 Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action