Clinical Trial Results:
A monocentric, double-blind, randomized phase III clinical study to investigate the antimicrobial efficacy and local tolerability of an antiseptic (Stellisept mucosa, containing 0.1 % octenidine dihydrochloride) after a single application at the genital mucosa in comparison to a reference product (Octenisept®) in a panel of 44 healthy male and female volunteer
Summary
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EudraCT number |
2006-000063-28 |
Trial protocol |
DE |
Global completion date |
21 Jun 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 |
23 Jun 2022
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First version publication date |
23 Jun 2022
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Other versions |
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Summary report(s) |
2006-000063-28 Stellisept mucosa |
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.