Clinical Trial Results:
Monocenter, open-label, randomized study to determine the ovulation inhibitory effect of the combined oral contraceptives SH T04769G (0.015 mg Ethinylestradiol and 1.5 mg Dienogest in a modified release medicinal product) and SH D00659AF (0.03 mg Ethinylestradiol and 2.0 mg Dienogest), applied for two treatment cycles to 60 healthy female volunteers
Summary
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EudraCT number |
2006-006633-41 |
Trial protocol |
DE |
Global completion date |
03 Dec 2007
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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
|
First version publication date |
11 Dec 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.