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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Hypogonadism, Erectile Dysfunction

Intervention / Treatment
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* Drug: Testosterone Undecanoate,1000mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with ED over 3 months (specify using IIEF score) Age >= 18 years. Stable sexual relationship With low or low normal serum testosterone level (either total or bioavailable testosterone) TT <= 4 ng/ml and/or BT <= 1 ng/ml Aging Male Symptom scale with total score starting at 37 points (must not replace TT < 4 ng/ml) Eligible subjects who previously took the oral androgen or PDE5 inhibitor must have discontinued their use for 1 month Exclusion Criteria: Contraindication to treatment with Testosterone according to the SPC Hypersensitivity to the active substances or any of the excipients of Nebido Diagnosed or suspected carcinoma of the prostate or the male breast cancer Past or present liver tumors Acute or chronic hepatic diseases Severe cardiac, hepatic or renal insufficiency History of penile implant or significant penile deformity Diagnosed sleep apnea Polycythemia (Hematocrit >50%) Prolactin >25 ng/ml Organic hypothalamic-pituitary pathology Any unstable medical, psychiatric or drug/alcohol abuse disorder Prostate specific antigen (PSA)>= 4 ng/ml Severe symptomatic benign prostatic hyperplasia (IPSS) sum score >=20) Diabetes mellitus which is uncontrolled (HbAlc level >10%) Epilepsy not adequately controlled by treatment Patients requiring fertility treatment Hypertension which is not adequately controlled on therapy Clinically significant chronic hematological disease which may lead to priapism such as sickle cell anemia, multiple myeloma or leukemia Hypersensitivity to PDE-5 inhibitors 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Testosterone Undecanoate,1000mg|duration for 4 injections|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Testosterone level |  | at 6,12,18,36,46 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nebido in hypogonadism with erectile dysfunction