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Clinical Trial Results:
Safety of the oral monophasic contraceptive GRT4248 (0.02 mg ethinylestradiol/2 mg chlormadinone acetate) in comparison to 0.02 mg ethinylestradiol/0.15 mg desogestrel given for 6 medication cycles Randomised, multicentre, double-blind, desogestrel-controlled, parallel group, multiple administration, phase III study in a proposed number of 400 volunteers
Summary | |
EudraCT number | 2004-003035-31 |
Trial protocol | DE IT ES |
Global completion date | 16 Aug 2006 |
Paediatric regulatory details | |
Is the trial part of an agreed EMA paediatric investigation plan? | No |
Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? | No |
Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? | No |
Results information | |
Results version number | v1(current) |
This version publication date | 02 Sep 2016 |
First version publication date | 02 Sep 2016 |
Other versions | |
Summary report(s) | 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.