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
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