Study Objectives. The objectives of this study are therefore as follows: · To provide a clinical and statistical basis for the selection of the optimal dose of ER-306323 to be taken forward into final development · To demonstrate proof of efficacy of ER-306323 for reduction in frequency and severity of hot flashes in postmenopausal women. · To determine the pharmacodynamic. effects (i.e., effects on mineral metabolism and biochemical markers of bone formation and resorption) of [*] months of treatment with ER-306323. · To determine the effects of [*] months of treatment with ER-306323 on BMD. · To determine the overall safety and tolerability of ER-306323 after [*] months of dosing in postmenopausal women with vasomotor symptoms. · To determine the uterine safety of ER-306323 after [*]months of dosing in postmenopausal women with vasomotor symptoms.
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Sources: License Agreement (Radius Health, Inc.), License Agreement (Radius Health, Inc.), License Agreement (Radius Health, Inc.)