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

Bayer

Status: Completed

Conditions: Hypogonadism; Male

Treatments: Drug: Testosterone Undecanoate (Nebido, BAY86-5037)

Study type: Observational

Funder types: Industry

Identifiers

NCT00410306

14203

NE0601

2005/00888

39732

MP-04199

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,493 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,493 participants in 1 patient group

Group 1

Treatment:

Drug: Testosterone Undecanoate (Nebido, BAY86-5037)