NCT00700024

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

September 21, 2009

Status Verified

September 1, 2009

Enrollment Period

1.8 years

First QC Date

June 16, 2008

Last Update Submit

September 18, 2009

Conditions

HypogonadismMetabolic Syndrome

Keywords

Body compositionPhysical activityMetabolic syndrome

Outcome Measures

Primary Outcomes (1)

  • Lean body mass

    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

    january 2008-january 2010

Study Arms (3)

1

ACTIVE COMPARATOR

testim

Drug: Testim

2

EXPERIMENTAL

placebo

Drug: placebo

3

EXPERIMENTAL

training

Behavioral: Strength training

Interventions

TestimDRUG

50 mg/dose7day

Also known as: testosteron
1
Strength trainingBEHAVIORAL

three times a week

Also known as: training
3
placeboDRUG

placebo

Also known as: gel
2

Eligibility Criteria

Age65 Years - 78 Years
Sexmale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, Odense, 5000, Denmark

Location

Related Publications (4)

  • 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.

    PMID: 32853647DERIVED

  • 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.

    PMID: 29656500DERIVED

  • 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.

    PMID: 24089589DERIVED

  • 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.

    PMID: 23730808DERIVED

MeSH Terms

Conditions

HypogonadismMetabolic SyndromeMotor Activity

Interventions

TestosteroneTestosterone PropionateResistance TrainingGels

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Officials

  • Marianne Andersen, Md, phd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 16, 2008

First Posted

June 18, 2008

Study Start

April 1, 2008

Primary Completion

January 1, 2010

Study Completion

February 1, 2010

Last Updated

September 21, 2009

Record last verified: 2009-09

Locations

DK(1)