Clinical Trial Results:
A Randomized double-blind study of testosterone replacement therapy or placebo in testicular cancer survivors with mild Leydig Cell Insufficiency (Einstein-intervention)
Summary
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EudraCT number |
2015-001452-30 |
Trial protocol |
DK |
Global end of trial date |
06 Jun 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
07 Jan 2021
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First version publication date |
07 Jan 2021
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Other versions |
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 |
010815testis
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02991209 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Copenhagen University hospital Rigshospitalet
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Sponsor organisation address |
Blegdamsvej 9, Copenhagen, Denmark,
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Public contact |
Clinical Research Unit Information, Copenhagen University Hospital Rigshospitalet, mikkel.bandak@regionh.dk
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Scientific contact |
Clinical Research Unit Information, Copenhagen University Hospital Rigshospitalet, mikkel.bandak@regionh.dk
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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 |
06 Jun 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
06 Jun 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
06 Jun 2019
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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 |
Investigation of changes in insulin sensitivity after 12 months treatment with testosterone substitution
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Protection of trial subjects |
None
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Oct 2016
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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 |
Denmark: 69
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Worldwide total number of subjects |
69
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EEA total number of subjects |
69
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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) |
69
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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 |
- | |||||||||
Pre-assignment
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Screening details |
Between October 2016 and February 2018, 140 patients were screened for eligibility and 69 were subsequently randomized to receive testosterone (n=35) or placebo (n=34) | |||||||||
Period 1
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Period 1 title |
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, Monitor, Data analyst, Carer, Assessor | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Testosterone | |||||||||
Arm description |
Active treatment | |||||||||
Arm type |
Placebo | |||||||||
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 |
Gel
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Routes of administration |
Transdermal use
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Dosage and administration details |
Tostran 10 mg a day to a max dose of 40 mg a day, transdermally
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Arm title
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Placebo | |||||||||
Arm description |
- | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
placebo
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Investigational medicinal product code |
t
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Other name |
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Pharmaceutical forms |
Gel
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Routes of administration |
Transdermal use
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Dosage and administration details |
Transdermal gel
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Baseline characteristics reporting groups
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Reporting group title |
Testosterone
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Reporting group description |
Active treatment | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Testosterone
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Reporting group description |
Active treatment | ||
Reporting group title |
Placebo
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Reporting group description |
- |
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End point title |
Delta 2-hour glucose | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
12-months
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Statistical analysis title |
mixed effect linear model | ||||||||||||
Comparison groups |
Testosterone v Placebo
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Number of subjects included in analysis |
58
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
≤ 0.05 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Confidence interval |
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End point title |
Delta 2-hour insulin | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
12-months
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Statistical analysis title |
mixed effect linear model | ||||||||||||
Comparison groups |
Testosterone v Placebo
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Number of subjects included in analysis |
58
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
≤ 0.05 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Confidence interval |
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End point title |
Systolic blood pressure | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
12-months
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Statistical analysis title |
mixed effect linear model | ||||||||||||
Comparison groups |
Testosterone v Placebo
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Number of subjects included in analysis |
58
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
≤ 0.05 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Mean difference (net) | ||||||||||||
Confidence interval |
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End point title |
Diastolic blood pressure | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
12- monhts
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Statistical analysis title |
Mixed effect linear model | ||||||||||||
Comparison groups |
Testosterone v Placebo
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Number of subjects included in analysis |
58
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
≤ 0.05 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Confidence interval |
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End point title |
triglycerides | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
12-months
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No statistical analyses for this end point |
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End point title |
HDL | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
12-months
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No statistical analyses for this end point |
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End point title |
waist circumference | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
12 months
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No statistical analyses for this end point |
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End point title |
Fasting blood glucose | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
12 months
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Overall period
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
CTC | ||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
4.0
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Reporting groups
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Reporting group title |
Testosterone
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Reporting group description |
Active treatment | ||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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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? Yes | |||
Date |
Amendment |
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10 Nov 2017 |
The amendment allowed inclusion of patients with serum free testosterone level between -3 SD and the age-adjusted upper limit of normal (+2 SD) in combination with serum LH above +1 SD |
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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 |