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

Bayer1,493 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,493

Conditions

Male Hypogonadism

Interventions

Testosterone Undecanoate (Nebido, BAY86-5037)DRUG

Patients from routine practice

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (33)

Unnamed facility

Many Locations, Australia

Unnamed facility

Many Locations, Austria

Outcomes

Primary Outcomes

Adverse events, adverse drug reactions, patient reported tolerability

Time frame: during 4 injection intervals

Secondary Outcomes

Change in laboratory values (total testosterone, estradiol, SHGB, FSH, LH) from baseline to end of observation