A randomized, double-blind, placebo-controlled phase 2 clinical study to evaluate the efficacy and safety of HS-10384 in postmenopausal women suffering from vasomotor symptoms.
The phase 2 study is consisted with 2 doses. The aim is to detect the efficacy, safety, pharmacokinetics and pharmacodynamics characteristics of HS-10384 in participants with vasomotor symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
195
Administered orally QD
Administered orally QD
Administered orally QD
Chinese Academy of Medical Sciences (CAMS)Peking Union Medical College (PUMC)
Shanghai, Shanghai Municipality, China
Mean change in the frequency of moderate to severe vasomotor symptoms from baseline to Week 4;
Time frame: Baseline to Week 4
Mean change in the frequency of moderate to severe vasomotor symptoms from baseline to Week 12;
Time frame: Baseline to Week 12
Mean change in the severity of moderate to severe vasomotor symptoms from baseline to Week 4;
Time frame: Baseline to Week 4
Mean change in the severity of moderate to severe vasomotor symptoms from baseline to Week 12.
Time frame: Baseline to Week 12
Mean change in the frequency of moderate and severe vasomotor symptoms from baseline to each study week;
Time frame: Baseline to Week 15
Mean change in the severity of moderate and severe vasomotor symptoms from baseline to each study week;
Time frame: Baseline to Week 15
Mean change in the hot flash score of moderate and severe vasomotor symptoms from baseline to each study week;
Time frame: Baseline to Week 15
Mean percent reduction of 50% and 100% of moderate and severe vasomotor symptoms from baseline to each study week.
Time frame: Baseline to Week 15
Incidence and severity of treatment-emergent adverse events;
Time frame: Baseline to Week 15
Number of participants with clinical laboratory abnormalities;
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Time frame: Baseline to Week 15
Number of participants with abnormalities of vital signs
Time frame: Baseline to Week 15
Number of participants with abnormalities of physical examinations
Time frame: Baseline to Week 15
Change from baseline in ECG parameters
Time frame: Baseline to Week 15
Change from baseline in plasma bone density marker concentrations
Time frame: Baseline to Week 15
Change from baseline in Endometrial health assessment.
Time frame: Baseline to Week 15