Use of Nebido® to Assess Tolerability and Treatment Outcomes in Daily Clinical Practice
- Registration Number
- NCT00410306
- Lead Sponsor
- Bayer
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 1493
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Testosterone Undecanoate (Nebido, BAY86-5037) -
- Primary Outcome Measures
Name Time Method Adverse events, adverse drug reactions, patient reported tolerability during 4 injection intervals
- Secondary Outcome Measures
Name Time Method 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