Use of Nebido® to Assess Tolerability and Treatment Outcomes in Daily Clinical Practice

Study Overview
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Brief Summary
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This is an observational study with a drug called Nebido, a new testosterone replacement therapy, which is available for the treatment of male hypogonadism. The benefit and safety of Nebido have already been thoroughly evaluated through well controlled clinical trials. The main purpose of this observational study is to confirm the established safety profile of Nebido in daily clinical practice.

Detailed Description
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The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Official Title
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International, Multi-center Post Authorization Surveillance Study on the Use of Nebido® to Assess Tolerability and Treatment Outcomes in Daily Clinical Practice (IPASS Nebido)

Conditions
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Male, Hypogonadism

Intervention / Treatment
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* Drug: Testosterone Undecanoate (Nebido, BAY86-5037)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male hypogonadal patients eligible for long-term testosterone therapy who have newly been prescribed Nebido® in accordance with the terms of the marketing authorization Exclusion Criteria: Patients presenting with contraindications as stated in the product information

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Testosterone Undecanoate (Nebido, BAY86-5037)<br>* Patients from routine practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, adverse drug reactions, patient reported tolerability |  | during 4 injection intervals | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in laboratory values (total testosterone, estradiol, SHGB, FSH, LH) from baseline to end of observation |  | after 4 injection intervals | 
| Change in subjective assessment of the patient (overall sexual desire/libido, vigor/vitality, mood, ability to concentrate) from baseline to end of observation |  | after 4 injection intervals | 
| Change in intensity of symptoms or disorders associated with low testosterone (hot flushes or excessive sweating, sleep disturbances, decreased physical strength and erectile dysfunction) from baseline to end of observation |  | after 4 injection intervals | 
| Patient reported outcome at end of observation (satisfaction with current androgen therapy, comparison to previous androgen therapy, if applicable) |  | after 4 injection intervals | 
| Treatment continuation rate |  | after 4 injection intervals | 
| Vital signs and anthropometric measurements (Blood pressure, heart rate, weight and waist circumference) |  | during 4 injection intervals | 
| Laboratory values (PSA, hemoglobin, hematocrit, HbA1C, T-chol, HDL-chol, LDL-chol, triglycerides) |  | during 4 injection intervals | 
| Digital rectal examination |  | during 4 injection intervals | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypogonadism, Nebido, Testosterone, Observational Study