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NEBIDO in Symptomatic Late Onset Hypogonadism (SLOH)

Primary Purpose

Hypogonadism

Status
Terminated
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Testosterone Undeconate (Nebido, BAY86-5037)
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogonadism focused on measuring Testosterone undecanoate, Hypogonadism

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Dynamic maximum strength -one repetition maximum (1-RM ) - of upper and lower extremity after 54 weeks

Secondary Outcome Measures

Isometric maximum strength
Grip strength
Chair raising test
Arm curl test
Bicycle stress test with spirometry
SF-36 Questionnaire
AMS-Questionnaire
FINGER Questionnaire

Full Information

First Posted
March 24, 2010
Last Updated
November 3, 2014
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT01092858
Brief Title
NEBIDO in Symptomatic Late Onset Hypogonadism (SLOH)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Study Start Date
September 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism
Keywords
Testosterone undecanoate, Hypogonadism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Testosterone Undeconate (Nebido, BAY86-5037)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo i.m. injections at baseline, at week 6, at week 18 at week 30 and at week 42, respectively
Primary Outcome Measure Information:
Title
Dynamic maximum strength -one repetition maximum (1-RM ) - of upper and lower extremity after 54 weeks
Time Frame
At baseline, at week 54
Secondary Outcome Measure Information:
Title
Isometric maximum strength
Time Frame
At baseline, at week 54
Title
Grip strength
Time Frame
At baseline, at week 54
Title
Chair raising test
Time Frame
At baseline, at week 54
Title
Arm curl test
Time Frame
At baseline, at week 54
Title
Bicycle stress test with spirometry
Time Frame
At baseline, at week 54
Title
SF-36 Questionnaire
Time Frame
At baseline, at week 54
Title
AMS-Questionnaire
Time Frame
At baseline, at week 54
Title
FINGER Questionnaire
Time Frame
At baseline, at week 54

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50931
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.clinicaltrialsregister.eu
Description
Click here and search for information of Bayer products for Europe

Learn more about this trial

NEBIDO in Symptomatic Late Onset Hypogonadism (SLOH)

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