Clinical Trial Results:
A multi-centre, randomized, double-blind, active control, parallel-group, 2-arm study to investigate the effect of ethinylestradiol / drospirenone / (0.02 mg/3 mg) oral contraception in a 24/4 regimen compared to ethinylestradiol / desogestrel (0.02 mg/0.15 mg) oral contraception in a 21/7 regimen on hormone withdrawal associated symptoms in otherwise healthy women after 4 cycles of treatment
Summary
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EudraCT number |
2009-014911-11 |
Trial protocol |
DE PT CZ IT GB |
Global completion date |
28 Oct 2011
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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
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First version publication date |
09 Nov 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.