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A DOUBLE-BLIND, RANDOMIZED, PLACEBO-AND ACTIVE-CONTROLLED EFFICACY AND SAFETY STUDY OF THE EFFECTS OF BAZEDOXIFENE/CONJUGATED ESTROGENS COMBINATIONS ON ENDOMETRIAL HYPERPLASIA AND PREVENTION OF OSTEOP...

Update Il y a 5 ans
Reference: EUCTR2008-003203-32

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-AND ACTIVE-CONTROLLED EFFICACY AND SAFETY STUDY OF THE EFFECTS OF BAZEDOXIFENE/CONJUGATED ESTROGENS COMBINATIONS ON ENDOMETRIAL HYPERPLASIA AND PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN

Woman Man

  • | Country :
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  • | organs :
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  • | Specialty :
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Extract

Primary Safety Objective: To confirm the endometrial safety of BZA 20 mg/CE 0.45 mg and BZA 20 mg/CE 0.625 mg based on an endometrial hyperplasia incidence of less than 1% at year 1. Primary Efficacy Objective: To assess the effect of BZA/CE in preventing postmenopausal osteoporosis at year 1 (osteoporosis substudy)

Inclusion criteria

  • Menopause

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