Primary: 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. Secondary: To assess the effects of DVS-233 SR and tibolone on changes from baseline in weight, breast pain, and health outcomes indicators.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
465
Unnamed facility
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.
To assess the effects of DVS-233 SR and tibolone on changes from baseline in weight, breast pain, and health outcomes indicators.
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Leuven, Belgium
Unnamed facility
Zadar, Croatia
Unnamed facility
Zagreb, Croatia
Unnamed facility
Olomuc, Czechia
Unnamed facility
Ostrava, Czechia
Unnamed facility
Přerov, Czechia
Unnamed facility
Kuopio, Finland
Unnamed facility
Kuopio, Finland
Unnamed facility
Oulu, Finland
Unnamed facility
Évry, France
...and 31 more locations