Effect of transdermal testosterone replacement in hypogonadal men with decreased insulin sensitivity
| ISRCTN | ISRCTN45741714 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45741714 |
| Secondary identifying numbers | TSX/01/C |
- Submission date
- 23/01/2006
- Registration date
- 06/02/2006
- Last edited
- 07/04/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof K Channer
Scientific
Scientific
Department of Cardiology
Royal Hallamshire Hospital
Sheffield
S10 2JF
United Kingdom
Study information
| Study design | Interventional randomised double-blind placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effect of transdermal testosterone replacement in hypogonadal men with decreased insulin sensitivity |
| Study acronym | TIMES2 |
| Study objectives | To assess the effect of transdermal testosterone replacement in hypogonadal men with decreased insulin sensitivity |
| Ethics approval(s) | Huntingdon Research Ethics Committe, 20/09/2005, ref: 05/Q0104/132 |
| Health condition(s) or problem(s) studied | Hypogonadal men with decreased insulin sensitivity |
| Intervention | Once daily testosterone replacement gel 2% versus placebo gel |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Testosterone replacement gel 2% |
| Primary outcome measure | 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 study start date | 31/01/2006 |
| Completion date | 31/08/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 320 |
| Key inclusion criteria | 1. Hypogonadal males 2. Decreased insulin sensitivity |
| Key exclusion criteria | 1. Use of testosterone replacement therapy in the last six months 2. History of or current prostate carcinoma |
| Date of first enrolment | 31/01/2006 |
| Date of final enrolment | 31/08/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Hallamshire Hospital
Sheffield
S10 2JF
United Kingdom
S10 2JF
United Kingdom
Sponsor information
ProStrakan Pharmaceuticals (UK)
Industry
Industry
Galabank Business Park
Galashiels
TD1 1QH
United Kingdom
| Phone | +44 (0)189 666 4000 |
|---|---|
| ewan.morrison@prostrakan.com | |
| Website | http://www.prostrakan.com |
"ROR" |
https://ror.org/017hh7b56 |
Funders
Funder type
Industry
ProStrakan Pharmaceuticals Ltd
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2011 | Yes | No | |
| Results article | substudy results | 21/12/2013 | Yes | No |
