Clinical Trial Results:
Multi-center, double-blind, randomized study to investigate the impact of a sequential oral contraceptive containing estradiol valerate and dienogest (SH T00658ID) compared to a monophasic contraceptive containing ethinylestradiol and levonorgestrel (Microgynon) over 6 treatment cycles on alleviating complaints of reduced libido in women with acquired female sexual dysfunction (FSD) associated with oral contraceptive use
Summary
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EudraCT number |
2008-002263-13 |
Trial protocol |
AT DE BE ES IT |
Global completion date |
20 Jul 2010
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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 |
12 Jul 2016
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First version publication date |
05 Dec 2014
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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.