Assessment of Long Term Treatment With Testosterone Undecanoate in Males With Hypogonadism

Phase 3

Completed

• Conditions: Hypogonadism
• Interventions: Drug: Testosterone undecanoate (TU) - NebidoTM

• Registration Number: NCT00220298
• Lead Sponsor: Bayer

Brief Summary

This study will evaluate the preparation of testosterone undecanoate under conditions which resemble real-life situations.

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.

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2005-09-16
• Study First Submitted QC: 2005-09-16
• Study First Posted: 2005-09-22
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-29
• Last Update Posted: 2014-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 96

Inclusion Criteria

• Hypogonadal men, aged 18-75 years with low serum total testosterone (TT) levels and symptoms of androgen deficiency

Exclusion Criteria

• Tumors of the prostate or the male mammary gland including suspicion thereof. Past or present liver tumors or chronic hepatic disease with impairment of liver function, Severe acne.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Testosterone undecanoate (TU) - NebidoTM	-

Primary Outcome Measures

Name	Time	Method
Efficacy and Safety of long term treatment with TU under real-life conditions	Every 3 months during treatment and after final injection

Secondary Outcome Measures

Name	Time	Method
Assessment of treatment satisfaction by patient	6,10, and 14 injections