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.