Randomized, double-blind, placebo-controlled study of HRS9531 in PCOS subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
144
HRS9531
HRS9531placebo
Percentage change in body weight from baseline at 32 weeks of treatment
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Proportion of subjects with regular menstruation at 32 weeks of treatment
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Change in spontaneous menstrual frequency ratio from baseline at 32 weeks of treatment
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Proportion of subjects who ovulated regularly after 32 weeks of treatment
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Proportion of subjects with weight loss of ≥5%, ≥10%, ≥15%, ≥20% from baseline at 32 weeks of treatment
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BMI changes relative to baseline after 32 weeks of administration;
Time frame: 0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week
Changes in waist circumference (WC) from baseline after 32 weeks of administration
Time frame: 0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week
Proportion of subjects with at least 3 menstrual cycles of 21-35 days after 12-32 weeks of treatment;
Time frame: 0week, 4week ,8week, 12week, 16week, 20week , 24week, 28week, 32week
Changes in total testosterone (TT)from baseline after 32 weeks of administration
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Time frame: 0week, 12week, 24week, 32week
Changes in sex hormone binding globulin (SHBG)from baseline after 32 weeks of administration
Time frame: 0week, 12week, 24week, 32week
Changes in free testosterone index (FAI),from baseline after 32 weeks of administration
Time frame: 0week, 12week, 24week, 32week
Changes in anti-Miller tube hormone (AMH),from baseline after 32 weeks of administration
Time frame: 0week, 12week, 24week, 32week
Changes in follicle stimulating hormone (FSH),from baseline after 32 weeks of administration
Time frame: 0week, 12week, 24week, 32week
Changes in luteinizing hormone (LH)from baseline after 32 weeks of administration
Time frame: 0week, 12week, 24week, 32week
Changes in LH/FSH;from baseline after 32 weeks of administration
Time frame: 0week, 12week, 24week, 32week
Changes in fasting plasma glucose (FPG)from baseline after 32 weeks of administration
Time frame: 0week, 12week, 24week, 32week
Changes in fasting serum insulin (FINS),from baseline after 32 weeks of administration
Time frame: 0week, 12week, 24week, 32week
Changes in insulin resistance index (HOMA-IR)from baseline after 32 weeks of administration
Time frame: 0week, 12week, 24week, 32week
Changes in triglycerides from baseline after 32 weeks of administration
Time frame: 0week, 12week, 24week, 32week
Changes in total cholesterol (TC),from baseline after 32 weeks of administration
Time frame: 0week, 12week, 24week, 32week
Changes in, low density lipoprotein cholesterol (LDL-C)from baseline after 32 weeks of administration
Time frame: 0week, 12week, 24week, 32week
Changes in high density lipoprotein cholesterol (HDL-C)from baseline after 32 weeks of administration
Time frame: 0week, 12week, 24week, 32week
Changes in blood pressure from baseline
Time frame: 0week, 4week,12week, 24week, 32week
Adverse events,
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