Clinical Trial Results:
Multi-center, open, randomized, parallel group comparison of cycle control for seven cycles and endometrial safety in a subgroup for thirteen cycles of contraceptive patch SH P00331F (0.9 mg ethinylestradiol/1.9 mg gestodene) vs a contraceptive comparator patch (0.75 mg ethinylestradiol/6 mg norelgestromin) in 400 healthy female volunteers
Summary
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EudraCT number |
2004-000821-31 |
Trial protocol |
FI ES AT |
Global completion date |
20 Apr 2006
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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 |
30 Apr 2016
|
First version publication date |
30 Apr 2016
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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.