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Odense Androgen Study - The Effect of Testim and Training in Hypogonadal Men

Primary Purpose

Hypogonadism, Metabolic Syndrome

Status

Unknown status

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Testim

Strength training

placebo

About this trial

This is an interventional treatment trial for Hypogonadism focused on measuring Body composition, Physical activity, Metabolic syndrome

Eligibility Criteria

65 Years - 78 Years (Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Male 65-78
Bioavailable testosterone < 7.3 nmol/L
Waist > 94 cm

Exclusion Criteria:

Haematocrit > 0.50
Known c. prostate or PSA > 3 Myg/L
Known malignant disease
Alcohol or drug abuse
BMI > 40 kg/m2
Use of 5 alpha reductance inhibitors
Plan to father children

Sites / Locations

Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Arm Description

testim

placebo

training

Outcomes

Primary Outcome Measures

Lean body mass

Secondary Outcome Measures

Insulin sensitivity, Visceral fat/liver fat, Body fat, Waist, Physical conditions and physical strengths, Adiponectin, Lipid metabolism, Subjective sensation of energy, Urine cortisol, Sexual function, Serum testosterone

Full Information

NCT ID

NCT00700024

First Posted

June 16, 2008

Last Updated

September 18, 2009

Sponsor

Odense University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00700024

Brief Title

Odense Androgen Study - The Effect of Testim and Training in Hypogonadal Men

Official Title

The Effect of Testim and Training in a Population Based, Randomized, Placebo-controlled, Double-blinded Study of Hypogonadal Men

Study Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Unknown status

Study Start Date

April 2008 (undefined)

Primary Completion Date

January 2010 (Anticipated)

Study Completion Date

February 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Odense University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine the effect of training and testim on Hypogonadism.

Detailed Description

The effect of testim and training in hypogonadal men.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypogonadism, Metabolic Syndrome

Keywords

Body composition, Physical activity, Metabolic syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

testim

Arm Title

Arm Type

Experimental

Arm Description

placebo

Arm Title

Arm Type

Experimental

Arm Description

training

Intervention Type

Drug

Intervention Name(s)

Testim

Other Intervention Name(s)

testosteron

Intervention Description

50 mg/dose7day

Intervention Type

Behavioral

Intervention Name(s)

Strength training

Other Intervention Name(s)

training

Intervention Description

three times a week

Intervention Type

Drug

Intervention Name(s)

placebo

Other Intervention Name(s)

gel

Intervention Description

placebo

Primary Outcome Measure Information:

Title

Lean body mass

Time Frame

january 2008-january 2010

Secondary Outcome Measure Information:

Title

Time Frame

january 2008-january 2010

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

78 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male 65-78 Bioavailable testosterone < 7.3 nmol/L Waist > 94 cm Exclusion Criteria: Haematocrit > 0.50 Known c. prostate or PSA > 3 Myg/L Known malignant disease Alcohol or drug abuse BMI > 40 kg/m2 Use of 5 alpha reductance inhibitors Plan to father children

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marianne Andersen, Md, phd

Official's Role

Principal Investigator

Facility Information:

Facility Name

Odense University Hospital

City

Odense

ZIP/Postal Code

5000

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

32853647

Citation

Kruse R, Petersson SJ, Christensen LL, Kristensen JM, Sabaratnam R, Ortenblad N, Andersen M, Hojlund K. Effect of long-term testosterone therapy on molecular regulators of skeletal muscle mass and fibre-type distribution in aging men with subnormal testosterone. Metabolism. 2020 Nov;112:154347. doi: 10.1016/j.metabol.2020.154347. Epub 2020 Aug 25.

Results Reference

derived

PubMed Identifier

29656500

Citation

Jensen RC, Christensen LL, Nielsen J, Schroder HD, Kvorning T, Gejl K, Hojlund K, Glintborg D, Andersen M. Mitochondria, glycogen, and lipid droplets in skeletal muscle during testosterone treatment and strength training: a randomized, double-blinded, placebo-controlled trial. Andrology. 2018 Jul;6(4):547-555. doi: 10.1111/andr.12492. Epub 2018 Apr 15.

Results Reference

derived

PubMed Identifier

24089589

Citation

Glintborg D, Christensen LL, Kvorning T, Larsen R, Brixen K, Hougaard DM, Richelsen B, Bruun JM, Andersen M. Strength training and testosterone treatment have opposing effects on migration inhibitor factor levels in ageing men. Mediators Inflamm. 2013;2013:539156. doi: 10.1155/2013/539156. Epub 2013 Sep 8.

Results Reference

derived

PubMed Identifier

23730808

Citation

Kvorning T, Christensen LL, Madsen K, Nielsen JL, Gejl KD, Brixen K, Andersen M. Mechanical muscle function and lean body mass during supervised strength training and testosterone therapy in aging men with low-normal testosterone levels. J Am Geriatr Soc. 2013 Jun;61(6):957-962. doi: 10.1111/jgs.12279. Epub 2013 Jun 3.

Results Reference

derived

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Odense Androgen Study - The Effect of Testim and Training in Hypogonadal Men

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