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Multicenter, randomized and single-blind (group assigned by chance and unknown to study subjects), comparator-controlled study with all groups running in parallel to investigate the pharmacological ef...

Mise à jour : Il y a 4 ans
Référence : EUCTR2013-003980-74

Multicenter, randomized and single-blind (group assigned by chance and unknown to study subjects), comparator-controlled study with all groups running in parallel to investigate the pharmacological effects, drug blood levels and safety of an intrauterine system releasing the study drug BAY 1007626 as compared to Mirena and Jaydess in healthy pre-menopausal women treated for 90 days to determine the study drug dose for further development Klinische Prüfung zur Bestimmung pharmakologischer Eigenschaften, der Wirkstoffkonzentration im Blut und der Sicherheit einer BAY1007626 freisetzenden Gebärmutterspirale im Vergleich mit Mirena und Jaydess bei gesunden, jungen Frauen über 90 Tage zur Bestimmung der Dosis für die weitere Arzneimittelentwicklung

Femme Homme

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Extrait

The primary objective of this study is to investigate local and systemic effects of BAY 1007626 on: – Number of bleeding and spotting days, – Endometrial histology, – Ovulation (as surrogate for systemic effects).

Critère d'inclusion

  • Contraception

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