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OpenTrials
Completed

NCT Number: NCT00220298

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

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

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Key information

Conditions

Hypogonadism Endocrine System Diseases Gonadal Disorders

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Nuremberg, Bavaria, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Testosterone undecanoate (TU) - NebidoTM

Drug

Drug treatment with 14 injections of one ampoule of Nebido (1000 mg of testosterone undecanoate) at individually adjusted injection intervals

Primary outcomes

  1. Efficacy and Safety of long term treatment with TU under real-life conditions

    Time frame: Every 3 months during treatment and after final injection

Secondary outcomes

  1. Assessment of treatment satisfaction by patient

    Time frame: 6,10, and 14 injections

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Open One-arm Study to Investigate Safety and Efficacy of Intramuscular Injections of 1000 mg Testosterone Undecanoate (TU) in Hypogonadal Men at Variable Intervals During a 136-week to 192-week Treatment Including Pharmacokinetics

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Sep 22, 2005
Registry last updated
Dec 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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