Clinical Trial Results:
A randomised, double blind, placebo controlled study to assess the effect of testosterone treatment on arterial stiffness in patients with type 2 diabetes, peripheral vascular disease and hypogonadism.
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Summary
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EudraCT number |
2005-003652-35 |
Trial protocol |
GB |
Global end of trial date |
01 Jun 2006
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Results information
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Results version number |
v1(current) |
This version publication date |
24 Oct 2021
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First version publication date |
24 Oct 2021
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
300
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Barnsley Hospital NHS Foundation Trust
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Sponsor organisation address |
Research and Development, Block 14, Barnsley Hospital, Gawber Road, Barnsley, United Kingdom, S75 2EP
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Public contact |
Barnsley Hospital NHS Foundation Trust, Barnsley Hospital NHS Foundation Trust, barnsley.research@nhs.net
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Scientific contact |
Barnsley Hospital NHS Foundation Trust, Barnsley Hospital NHS Foundation Trust, barnsley.research@nhs.net
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
31 May 2007
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Jun 2006
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To test the effect of twelve weeks of testosterone replacement, given as Sustanon 250 IM injection, on arterial stiffness measured by ultrasound derived stiffness index beta of the femoral artery in men with hypogonadism, type 2 diabetes mellitus and peripheral vascular disease (the study population).
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Protection of trial subjects |
Baseline safety assessments included physical examination with digital rectal examination, haematocrit (Cell-Dyn 4000 analyser, Abbott Laboratories USA) and PSA (chemiluminescent microparticle immunoassay, Abbott Laboratories, USA). Patients with evidence of prostate cancer on digital rectal examination, raised PSA or polycythaemia were excluded from the trial and referred for appropriate specialist assessment if indicated. Safety assessments were repeated at 12 and 26 weeks and subjects withdrawn from the study if safety parameters were breached.
Questions with regard to adverse events were specifically asked at 3 and 6 months. The relevant questions were “have you had any new symptoms since the start of the study?” and “have any symptoms or medical conditions got worse since starting the study?” Patients were encouraged to report adverse events at their visits for study medication injection which occurred every two weeks. They were also advised to contact the research team about any adverse events at any time during the study. All adverse events were reported to the chief investigator within 14 days.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Oct 2005
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 24
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Worldwide total number of subjects |
24
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EEA total number of subjects |
24
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
24
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||
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Pre-assignment
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Screening details |
Participants were men aged greater than 40 years with insulin treated type 2 diabetes on a stable insulin regime for greater than three months. They had evidence of hypogonadism as defined by serum testosterone levels less than 12 nmol/L on two consecutive morning samples taken on different days and symptoms of hypogonadism | |||||||||
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Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo | |||||||||
Arm description |
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Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo - saline
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for injection/infusion
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.8 ml 0.9% saline every two weeks
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Arm title
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Testosterone replacement therapy | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Testosterone
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for solution for injection/infusion
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.8 ml Sustanon 250 injection
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End points reporting groups
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Reporting group title |
Placebo
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Reporting group description |
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Reporting group title |
Testosterone replacement therapy
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Reporting group description |
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End point title |
HbA1C | ||||||||||||
End point description |
The primary outcome was the effect of 26 week testosterone replacement on diabetes control measured by HbA1C in hypogonadal men with type 2 diabetes treated with insulin
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End point type |
Primary
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End point timeframe |
26 weeks
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Statistical analysis title |
Baseline blood results | ||||||||||||
Comparison groups |
Placebo v Testosterone replacement therapy
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Number of subjects included in analysis |
24
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Analysis specification |
Pre-specified
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Analysis type |
other [1] | ||||||||||||
P-value |
= 0.531 | ||||||||||||
Method |
ANCOVA | ||||||||||||
Confidence interval |
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| Notes [1] - mean +/- standard deviation |
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Adverse events information
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Timeframe for reporting adverse events |
24 hours
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
12
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Reporting groups
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Reporting group title |
Placebo
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Reporting group description |
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Reporting group title |
Testosterone replacement therapy
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/17468196 |
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