Clinical Trial Results:
A multi-center, double-blind, double-dummy, controlled, randomized study to evaluate cycle control and safety of a four-phasic oral contraceptive containing estradiol valerate and dienogest (SH T00658ID) in comparison to an oral contraceptive containing ethinylestradiol and levonorgestrel (SH D 593 B) in healthy female volunteers aged between 18 and 50 years over 7 cycles
Summary
|
|
EudraCT number |
2004-001613-34 |
Trial protocol |
DE CZ |
Global completion date |
05 Sep 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 |
12 Jul 2016
|
First version publication date |
03 Jun 2015
|
Other versions |
|
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.