NCT01616732

Brief Summary

The investigators hypothesise that testosterone therapy will synergize with dietary intervention to achieve weight loss. Obese men will receive diet, and be randomised to either testosterone therapy or placebo. Primary outcomes will be weight and body composition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 8, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2012

Completed
10 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 6, 2016

Status Verified

June 1, 2016

Enrollment Period

2.6 years

First QC Date

June 8, 2012

Last Update Submit

June 3, 2016

Conditions

Obesity in Men

Outcome Measures

Primary Outcomes (1)

  • weight

    12 months

Study Arms (2)

testosterone

ACTIVE COMPARATOR

against placebo

Drug: Testosterone

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

TestosteroneDRUG

TU im

testosterone
placeboDRUG

placebo im

placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \>30

You may not qualify if:

  • contraindications to testosterone therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

Related Publications (2)

  • Grossmann M, Fui MNT, Nie T, Hoermann R, Clarke MV, Cheung AS, Zajac JD, Davey RA. Changes in white adipose tissue gene expression in a randomized control trial of dieting obese men with lowered serum testosterone alone or in combination with testosterone treatment. Endocrine. 2021 Aug;73(2):463-471. doi: 10.1007/s12020-021-02722-0. Epub 2021 Apr 17.

    PMID: 33864607DERIVED

  • Ng Tang Fui M, Prendergast LA, Dupuis P, Raval M, Strauss BJ, Zajac JD, Grossmann M. Effects of testosterone treatment on body fat and lean mass in obese men on a hypocaloric diet: a randomised controlled trial. BMC Med. 2016 Oct 7;14(1):153. doi: 10.1186/s12916-016-0700-9.

    PMID: 27716209DERIVED

MeSH Terms

Interventions

Testosterone

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 8, 2012

First Posted

June 12, 2012

Study Start

April 1, 2013

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

June 6, 2016

Record last verified: 2016-06

Locations

AU(1)