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Status unknownNCT00700024Updated Sep 21, 2009

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

A Phase 4 interventional study of Testim and Strength training in Hypogonadism and Metabolic Syndrome, sponsored by Odense University Hospital. Status unknown at 1 site in Denmark. Open to male participants aged 65 Years to 78 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-09-21.

Sponsored by Odense University Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2009), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
65 Years to 78 Years
Sex
Male
01

Study summary

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

Read the detailed description

The effect of testim and training in hypogonadal men.

02

Conditions studied

  • Hypogonadism
  • Metabolic Syndrome

Keywords

  • Body composition
  • Physical activity
  • Metabolic syndrome
03

In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

Odense University Hospital is the lead sponsor of 468 studies on the registry; 109 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 78 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    1

    testim

    Drug: Testim

  • Experimental
    2

    placebo

    Drug: placebo

  • Experimental
    3

    training

    Behavioral: Strength training

Interventions

  • DrugTestim

    50 mg/dose7day

    Also known as: testosteron

  • BehavioralStrength training

    three times a week

    Also known as: training

  • Drugplacebo

    placebo

    Also known as: gel

06

What researchers measure

Primary outcomes

  1. Lean body mass

    Time frame: january 2008-january 2010

Secondary outcomes

  1. 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

    Time frame: january 2008-january 2010

07

Study locations

1 site
  • Odense University Hospital
    Odense, 5000, Denmark
08

References and documents

Publications

  • 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. PubMed 32853647 ↗
  • 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. PubMed 29656500 ↗
  • 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. PubMed 24089589 ↗
  • 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. PubMed 23730808 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00700024
Lead sponsor
Odense University Hospital
First posted
Jun 18, 2008
Start date
Apr 2008
Primary completion
Jan 2010 (estimated)
Completion
Feb 2010 (estimated)
Last update
Sep 21, 2009

Study contacts

Marianne Andersen, Md, phd
principal investigator

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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