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

December 29, 2014 updated by: Bayer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10249
      • Berlin, Germany, 12159
      • Leipzig, Germany, 04289
    • Bayern
      • Nürnberg, Bayern, Germany, 90441
    • Hessen
      • Marburg, Hessen, Germany, 35037
    • Niedersachsen
      • Wolfsburg, Niedersachsen, Germany, 38440
    • Nordrhein-Westfalen
      • Münster, Nordrhein-Westfalen, Germany, 48129
    • Sachsen
      • Leipzig, Sachsen, Germany, 04299
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06112
      • Naumburg, Sachsen-Anhalt, Germany, 06618
    • Thueringen
      • Jena, Thueringen, Germany, 07740
      • Jena, Thueringen, Germany, 07743
    • Thüringen
      • Eisenberg, Thüringen, Germany, 07607
      • Gera, Thüringen, Germany, 07551

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Testosterone undecanoate (TU) - NebidoTM
Drug treatment with 14 injections of one ampoule of Nebido (1000 mg of testosterone undecanoate) at individually adjusted injection intervals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy and Safety of long term treatment with TU under real-life conditions
Time Frame: Every 3 months during treatment and after final injection
Every 3 months during treatment and after final injection

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of treatment satisfaction by patient
Time Frame: 6,10, and 14 injections
6,10, and 14 injections

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Behre HM and Elliesen J. Safety and efficacy of intramuscular injections of 1000 mg testosterone undecanoate: A prospective multicenter study in hypogonadal men under conditions resembling real-life situations. Proceedings of the 22nd Annual European Association of Urology (EAU); 2007 Mar 22; Berlin, Germany. Eur Urol Suppl 2007;6(2):108.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

December 30, 2014

Last Update Submitted That Met QC Criteria

December 29, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91186
  • 306605 (Other Identifier: company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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