Clinical Trial Results:
The effect of testosterone replacement in patients with hypogonadotroph hypogonadism due to opioid treatment for non-malignant disease
A double-blinded, randomized and placebo-controlled trial
Summary
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EudraCT number |
2014-004729-42 |
Trial protocol |
DK |
Global end of trial date |
04 Jul 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Nov 2020
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First version publication date |
26 Nov 2020
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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 |
22102014
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02433730 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Odense University Hospital
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Sponsor organisation address |
kløvervænget 6, Odense, Denmark, 5000
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Public contact |
Department of endocrinology, Odense University Hospital, department of endocrinology, +45 65412502, MSA@rsyd.dk
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Scientific contact |
Marianne Andersen, Odense University Hospital, department of endocrinology, +45 65412502, MSA@rsyd.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 |
01 Aug 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
04 Jul 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
04 Jul 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 |
To evaluate the efficacy of testosterone replacement therapy in men with OPIAD on body composition, the haemostatic system, glucose metabolism, muscle function, pain sensitivity, pain modulation, lipids, sexual function and quality of life.
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Protection of trial subjects |
NA
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jan 2015
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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: 41
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Worldwide total number of subjects |
41
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EEA total number of subjects |
41
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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) |
41
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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 |
Deltagere inviteres fra smerteklinikken OUH | |||||||||||||||
Pre-assignment
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Screening details |
lægelig vurdering | |||||||||||||||
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, Monitor, Data analyst | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Testosterone | |||||||||||||||
Arm description |
Modtager Nebido i 6 mdr | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Nebido
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection in pre-filled injector
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Routes of administration |
Intramuscular use
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Dosage and administration details |
1000 mg intramuscular injection
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Arm title
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Placebo | |||||||||||||||
Arm description |
injektions with placebo | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
4ml intramuscular injection
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Baseline characteristics reporting groups
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Reporting group title |
Testosterone
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Reporting group description |
Modtager Nebido i 6 mdr | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
injektions with placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Testosterone
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Reporting group description |
Modtager Nebido i 6 mdr | ||
Reporting group title |
Placebo
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Reporting group description |
injektions with placebo |
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End point title |
muscle mass | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
6 months
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Statistical analysis title |
Statistical analysis | ||||||||||||
Comparison groups |
Testosterone v Placebo
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Number of subjects included in analysis |
40
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
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End point title |
weight | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
6 months
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Statistical analysis title |
Statistical analysis | ||||||||||||
Comparison groups |
Testosterone v Placebo
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Number of subjects included in analysis |
39
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
Within 24 h
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Assessment type |
Systematic | |||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||
Dictionary version |
1
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Reporting groups
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Reporting group title |
placebo
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Reporting group description |
- | |||||||||||||||||||||
Reporting group title |
testosterone
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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/32213659 |