Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/01/2006
Date assigned
06/02/2006
Last edited
07/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof K Channer

ORCID ID

Contact details

Department of Cardiology
Royal Hallamshire Hospital
Sheffield
S10 2JF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

TSX/01/C

Study information

Scientific title

Effect of transdermal testosterone replacement in hypogonadal men with decreased insulin sensitivity

Acronym

TIMES2

Study hypothesis

To assess the effect of transdermal testosterone replacement in hypogonadal men with decreased insulin sensitivity

Ethics approval

Huntingdon Research Ethics Committe, 20/09/2005, ref: 05/Q0104/132

Study design

Interventional randomised double-blind placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Hypogonadal men with decreased insulin sensitivity

Intervention

Once daily testosterone replacement gel 2% versus placebo gel

Intervention type

Drug

Phase

Not Applicable

Drug names

Testosterone replacement gel 2%

Primary outcome measures

Change in insulin sensitivity

Secondary outcome measures

1. Change in abdominal obesity, lipid profile and glycaemic control
2. Change in symptoms of hypogonadism
3. The safety and tolerability of testosterone replacement gel compared to placebo gel

Overall trial start date

31/01/2006

Overall trial end date

31/08/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Hypogonadal males
2. Decreased insulin sensitivity

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

320

Participant exclusion criteria

1. Use of testosterone replacement therapy in the last six months
2. History of or current prostate carcinoma

Recruitment start date

31/01/2006

Recruitment end date

31/08/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Hallamshire Hospital
Sheffield
S10 2JF
United Kingdom

Sponsor information

Organisation

ProStrakan Pharmaceuticals (UK)

Sponsor details

Galabank Business Park
Galashiels
TD1 1QH
United Kingdom
+44 (0)189 666 4000
ewan.morrison@prostrakan.com

Sponsor type

Industry

Website

http://www.prostrakan.com

Funders

Funder type

Industry

Funder name

ProStrakan Pharmaceuticals Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21386088
2013 substudy results in: http://www.ncbi.nlm.nih.gov/pubmed/24165020

Publication citations

Additional files

Editorial Notes