Postmenopausal moderate to severe vasoconstriction
Conditions
Interventions
Experimental group:GS1-144 20 mg QD group
Control group:Placebo QD group
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
Female
Age
40 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1.40 to 64 years of age (inclusive) at the screening visit; 2.18.5 to 30 kg/m2 (inclusive); 3.Females meeting 1 of the following criteria of menopause at screening visit: spontaneous amenorrhea for >=12 consecutive months, spontaneous amenorrhea for >= 6 consecutive months with serum follicle-stimulating hormone (FSH) > 40 IU/L, or 6 weeks past a postsurgical bilateral oophorectomy with or without hysterectomy; 4.Participants who are seeking treatment or relief for VMS and meet the criteria for moderate to severe VMS symptoms: during the 7 consecutive days prior to randomization, participants must have a minimum average of 7 episodes of moderate to severe VMS symptoms per day; 5.For females with uterus: endometrial thickness 4mm without atypical hyperplasia or carcinogenesis of the endometrium from the subsequent biopsy results (if the biopsy sample is insufficient or can’t be obtained, it is considered normal and meeting this inclusion criterion); 6.Volunteered to sign ICF and be able to understand and comply with the requirements of this study;
Exclusion criteria
Exclusion criteria: 1.Diseases or dysfunctions known to interfere with the clinical trial, including but not limited to: neuropsychiatric, cardiovascular, urological, digestive, respiratory, musculoskeletal, metabolic, endocrine, haematological, immune, dermatological and oncological conditions, etc., such as poorly controlled chronic diseases with clinical relevance; 2.Thyroid or parathyroid-related hormones abnormalities or ultrasound findings with clinical relevance at screening or baseline, such as thyroid ultrasound results of TI-RADS category 4 or above; 3.Individuals with a history (within 6 months prior to screening) or imaging indicative of confirmed severe fatty liver at screening or baseline; 4.Individuals with a current or prior history of cirrhosis; 5.Any surgical or medical conditions that may significantly affect the absorption, distribution, metabolism, and excretion of the drug, such as a history of gastrointestinal surgery (gastrectomy, gastroenterostomy, enterectomy, cholecystectomy, etc.), urinary tract obstruction, or dysuria; 6.Current or prior history of malignancy (except for malignancies and basal cell carcinoma that have not received any antineoplastic treatment within 5 years prior to screening visit, or have currently recovered and have no risk of relapse during this study as assessed by the investigator); 7.Individuals with current or prior histological examinations indicating precancerous lesions, as well as those with imaging results suggestive of potential malignant lesions (such as solid pulmonary nodules > 8 mm, pulmonary ground-glass nodules and mixed ground-glass nodules > 5 mm); 8.Abnormal uterine bleeding with clinical relevance during screening or baseline period; 9.Participants who have attempted suicide within the last 1 year or are currently at risk of impulsive behavior or suicide; 10.Participants with a history of severe allergy to investigational products or any of their excipients or with allergic constitution (e.g., being allergic to two or more drugs or foods); 11.Participants who have positive results of hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab)/human immunodeficiency virus antigen/antibody(HIV-Ag/Ab) or syphilis-specific antibody; 12.Abnormalities in vital signs during the screening period or baseline period, e.g., resting pulse rate 105/min; systolic blood pressure = 160 mmHg; diastolic blood pressure = 100 mmHg, that upon evaluation by the investigator may interfere with this clinical study; 13.BI-RADS (Breast Imaging Reporting and Data System) Category >= 4 on breast ultrasounds within 6 months prior to randomization; 14.Participants who have positive pregnancy test during screening or baseline period; 15.12-lead electrocardiography (ECG) abnormalities during screening period or baseline period, e.g., heart rate-corrected QT interval QTcF absolute value > 470 ms (Fridericia's formula: QTcF=QT/RR0.33) that upon evaluation by the investigator may interfere with this clinical study; 16.Abnormalities in laboratory tests during screening period or baseline period, e.g., alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 × upper limit of normal (ULN), or total bilirubin (TBIL) > 1.0 × ULN, that upon evaluation by the investigator may have interfere with this clinical study; 17.Creatinine >1.5×ULN or estimated glomerular filtration rate (eGFR) < 60 mL/min/1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VMS electronic diary evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| PGI-S score;PGI-C score;Modified Kupperman scale score;MENQOL scale score; | — |
Countries
China
Contacts
Public ContactYu Qi
Peking Union Medical College Hospital
Outcome results
None listed