NEBIDO in Symptomatic Late Onset Hypogonadism (SLOH)

November 3, 2014 updated by: Bayer

Effect of Exercise Alone or in Combination With Testosterone Replacement on Muscle Strength and Quality of Life in Older Men With Low Testosterone Concentrations: a Randomized Double-blind, Placebo Controlled Study

The design of the study is a standard double-blind design, which is needed in this study to allow for unbiased evaluation of efficacy and safety. The effect of the additional impact of testosterone replacement therapy in hypogonadal men on muscle strength and quality of life in comparison to physical exercise alone will be assessed. Treatment duration will be 54 weeks, to monitor the increase as well as the "steady state" of the parameters assessed.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 4

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
    • Nordrhein-Westfalen
      • Köln, Nordrhein-Westfalen, Germany, 50931

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Men aged 60 years and older (>60yrs), untrained
  • Symptomatic hypogonadism as defined by a) and b)
  • a) Total testosterone below 12 nmol/l (measurement 7.00-11.00 a.m.)
  • b)Total Aging Males' symptom score above 36
  • Willing to avoid significant change in the pattern of physical exercise and lifestyle for the duration of the study
  • Residence in Cologne Area

Exclusion Criteria:

  • Previous assignment to treatment during this study
  • Use of androgen therapy or anabolic steroids respectively 12 months of entry into the study (i.e. screening visit/visit 1)
  • Current participation in an exercise program or within the last 6 months
  • Suspicion or known history of prostate or breast cancer or other hormone dependent neoplasia
  • Abnormal finding on Digital Rectal Examination (DRE)
  • Prostate specific antigen (PSA) level >4 ng/ml
  • History of clinically significant post void residual urine (> 150 ml)
  • Suspicion or known history of liver tumor
  • Hypersensitivity to the active substances or any of the excipients of NEBIDO e.g. benzyl-benzoate and castor oil
  • Blood coagulation irregularities presenting an increased risk of bleeding after intramuscular injections including vitamin-K-antagonists or other strong anticoagulants
  • 32 Additional Exclusion Criteria

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Testosterone Undeconate (Nebido, BAY86-5037)
Testosterone undecanoate 1000 mg (4 ml) i.m. injection at baseline, at week 6, at week 18, at week 30 and at week 42, respectively
Placebo Comparator: Arm 2
Drug: Placebo
Matching placebo i.m. injections at baseline, at week 6, at week 18 at week 30 and at week 42, respectively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dynamic maximum strength -one repetition maximum (1-RM ) - of upper and lower extremity after 54 weeks
Time Frame: At baseline, at week 54
At baseline, at week 54

Secondary Outcome Measures

Outcome Measure
Time Frame
Isometric maximum strength
Time Frame: At baseline, at week 54
At baseline, at week 54
Grip strength
Time Frame: At baseline, at week 54
At baseline, at week 54
Chair raising test
Time Frame: At baseline, at week 54
At baseline, at week 54
Arm curl test
Time Frame: At baseline, at week 54
At baseline, at week 54
Bicycle stress test with spirometry
Time Frame: At baseline, at week 54
At baseline, at week 54
SF-36 Questionnaire
Time Frame: At baseline, at week 54
At baseline, at week 54
AMS-Questionnaire
Time Frame: At baseline, at week 54
At baseline, at week 54
FINGER Questionnaire
Time Frame: At baseline, at week 54
At baseline, at week 54

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.

Helpful Links

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

September 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

March 24, 2010

First Submitted That Met QC Criteria

March 24, 2010

First Posted (Estimate)

March 25, 2010

Study Record Updates

Last Update Posted (Estimate)

November 5, 2014

Last Update Submitted That Met QC Criteria

November 3, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14853
  • 2009-017139-16 (EudraCT Number)

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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