Effect of transdermal testosterone replacement in hypogonadal men with decreased insulin sensitivity
| ISRCTN | ISRCTN45741714 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45741714 |
| Protocol serial number | TSX/01/C |
| Sponsor | ProStrakan Pharmaceuticals (UK) |
| Funder | ProStrakan Pharmaceuticals Ltd |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomised double-blind placebo-controlled study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Testosterone replacement gel 2% |
| Primary outcome measure(s) |
Change in insulin sensitivity |
| Key secondary outcome measure(s) |
1. Change in abdominal obesity, lipid profile and glycaemic control |
| Completion date | 31/08/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Royal Hallamshire Hospital
Sheffield
S10 2JF
United Kingdom
S10 2JF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
