Clinical Trial Results:
A single-center, open-label, crossover, randomized study to investigate the impact of the transdermal contraceptive patch containing 0.55 mg ethinylestradiol and 2.1 mg gestogene (material no. 80876395) in a 21-day regimen as compared to a monophasic contraceptive containing ethinyestradiol and levonogestrel (0.33 mg/0.15 mg) in a 21-day regimen on hemostatic parameters in 30 women aged 18-35 years over 3 treatment cycles in each period
Summary
|
|
EudraCT number |
2008-007024-26 |
Trial protocol |
DE |
Global completion date |
27 Sep 2010
|
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 |
27 Nov 2014
|
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.