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A Multicenter, Randomized, Double-Blind, Placebo- And Active-Controlled Study of DVS-233 SR for Treatment of Vasomotor Symptoms Associated with Menopause

Mise à jour : Il y a 4 ans
Référence : EUCTR2004-005022-45

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Extrait

To assess the efficacy and safety of DVS-233 SR compared with placebo for treatment of vasomotor symptoms (VMS) associated with menopause and to compare the bleeding incidence of DVS-233 SR and tibolone.

Critère d'inclusion

  • Generally healthy, postmenopausal women of age 40 to 65 seeking treatment for hot flushes with last natural menstrual period (LNMP) completed at least 12 months prior to screening (if LNMP is uncertain, the medical monitor or designee may approve a follicle-stimulating hormone [FSH] level; FSH level > 40 mIU/mL will allow enrollment)

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