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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...

Update Il y a 5 ans
Reference: 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

Woman Man

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Extract

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

Inclusion criteria

  • atrophic vaginitis

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