Clinical Trial Results:
A phase IV randomized, double-blind, 3-treatment, 3-period, 6-sequence crossover
clinical trial to assess the efficacy and safety of hyoscine butylbromide co-administered
with ibuprofen compared to placebos in participants suffering from primary dysmenorrhea
Summary
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EudraCT number |
2019-004138-41 |
Trial protocol |
DE |
Global completion date |
|
Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
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Results information
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Results version number |
v1(current) |
This version publication date |
21 Oct 2021
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First version publication date |
21 Oct 2021
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Other versions |
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Summary report(s) |
2019-004138-41 LPS16145-results-summary and Early Termination Form.pdf |
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.