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A 12 month, open-label, multi-center trial to investigate the endometrial safety of Vagifem Low Dose (10ug 17beta-estradiol vaginal tablet) in postmenopausal women with atrophic vaginitis symptoms. Tr...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-001629-24

A 12 month, open-label, multi-center trial to investigate the endometrial safety of Vagifem Low Dose (10ug 17beta-estradiol vaginal tablet) in postmenopausal women with atrophic vaginitis symptoms. Trial Phase: IIIa

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Extrait

To evaluate the endometrial hyperplasia rate from endometrial biopsies taken at the beginning and at the end of study treatment (12 months).

Critère d'inclusion

  • atrophic vaginitis

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