A Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Clinical Study to Evaluate the Efficacy and Safety of GS1-144 Tablets in the Treatment of Moderate to Severe Vasomotor Symptoms in Chinese Postmenopausal Women.

Changchun GeneScience Pharmaceutical Co., Ltd.1 site in 1 country129 target enrollmentOctober 14, 2024

ConditionsVasomotor Syndrome

InterventionsPlacebo GS1-144

DrugsPlacebo GS1-144

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Vasomotor Syndrome
Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Enrollment: 129
Locations: 1
Primary Endpoint: Changes from baseline in the frequency of moderate to severe VMS at Week 4.
Status: Completed
Last Updated: 3 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Clinical Study to Evaluate the Efficacy and Safety of GS1-144 Tablets in the Treatment of Moderate to Severe Vasomotor Symptoms in Chinese Postmenopausal Women.

Detailed Description

Registry

clinicaltrials.gov

Start Date

October 14, 2024

End Date

July 29, 2025

Last Updated

3 days ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•BMI is 18.5 to 30 kg/㎡(inclusive);
•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;
•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;
•For females with uterus: endometrial thickness ≤ 4mm as shown by TVU at screening, or \> 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 meets this inclusion criterion);
•Volunteered to sign ICF and be able to understand and comply with the requirements of this study.

Exclusion Criteria

•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., or poorly controlled chronic diseases with clinical significance;
•Thyroid or parathyroid-related hormones abnormalites with clinical significance at screening or baseline;
•Confirmed moderate to severe liver fatty at screening or baseline;
•Any surgical or medical conditions that may significantly affect the absorption, distribution, metabolism, and/or excretion of the drug, such as a history of gastrointestinal surgery (gastrectomy, gastroenterostomy, enterectomy, etc.), urinary tract obstruction, or dysuria;
•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 or have no risk of relapse during this study as assessed by the investigator);
•Abnormal uterine bleeding with clinical significance during screening period or baseline period;
•Participants who have attempted suicide within the last 1 year or are currently at risk of impulsive behavior or suicide;
•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);
•Participants who have positive serology results of hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab) or syphilis;Abnormalities in vital signs during the screening period or baseline period, e.g., resting pulse rate \< 55/min or \> 105/min; systolic blood pressure \< 90 mmHg or ≥ 160 mmHg; diastolic blood pressure \< 60 mmHg or ≥ 100 mmHg, that upon evaluation by the investigator may interfere with this clinical study;
•BI-RADS (Breast Imaging Reporting and Data System) Category ≥4 on breast ultrasound within 6 months prior to randomization;

Arms & Interventions

placebo

Participants will receive multiple doses of placebo matching GS1-144 tablet for 12 consecutive weeks.

Intervention: Placebo

GS1-144 tablet

Participants will receive multiple doses of GS1-144 tablets for 12 consecutive weeks.

Intervention: GS1-144

Outcomes

Primary Outcomes

Changes from baseline in the frequency of moderate to severe VMS at Week 4.

Time Frame: Week 4

VMS symptom electronic log. Patient's overall impression of change scale(PGI-C). A scale of a patient's overall impression of severity(PGI-S).Perimenopausal specific Quality of Life scale(MENQOL). Modified Kupperman scale.

Changes from baseline in the frequency of moderate to severe VMS at Week 12

Time Frame: Week 12

Secondary Outcomes

Changes from baseline in the severity of moderate to severe VMS at Week 4(Week 4)
Changes from baseline in the severity of moderate to severe VMS at Week 12(Week 12)