Clinical Trial Results:
International, prospective, double-blind, 3-arm comparative, randomized, placebo controlled phase IV study on the effect of counseling and either tranexamic acid or
mefenamic acid or placebo, on the management of bleeding/spotting in women using
the levonorgestrel-releasing intrauterine system (MIRENA) for contraception
Summary
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EudraCT number |
2010-020922-16 |
Trial protocol |
IE DK |
Global completion date |
19 Dec 2011
|
Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
12 Jul 2016
|
First version publication date |
31 Oct 2014
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Other versions |
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Summary report(s) |
Bayer Study Synopsis |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.