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.

NCT06726850 | Completed Phase 2

• 1 other identifier: GenSci074-201
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Vasomotor Syndrome

Outcome Measures

Primary Outcomes (2)

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

  Week 4

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

  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.

  Week 12

Secondary Outcomes (2)

• 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

Study Arms (2)

placebo

PLACEBO COMPARATOR

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

Drug: Placebo

GS1-144 tablet

EXPERIMENTAL

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

Drug: GS1-144

Interventions

Placebo DRUG

In the placebo arm, participants will consume a placebo matching GenSci1-144 for 12 consecutive weeks.

Also known as: Placebo tablet

placebo

GS1-144 DRUG

In the GS1-144 arm, participants will receive multiple doses of GS1-144 tablets for 12 consecutive weeks

GS1-144 tablet

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• Volunteered to sign ICF and be able to understand and comply with the requirements of this study.

You may not qualify if:

• 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;
• Participants who have positive pregnancy test during screening or baseline period.
• 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;
• Abnormalities in laboratory tests during screening period or baseline period, e.g., alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2×upper limit of normal (ULN), or total bilirubin (TBIL) \>1.5×ULN, that upon evaluation by the investigator may interfere with this clinical study;
• Creatinine \>1.5×ULN or estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m2 based on modification of diet in renal disease (MDRD) during screening period or baseline period;
• The participant has used or is using prohibited medications/therapies (moderate or strong CYP1A2 inhibitors, hormone replacement therapy or any VMS therapeutic agents \[prescription, non-prescription or herbal medicines\]) at screening and is unwilling to discontinue and wash out such medications throughout the study (see Section 6.9 for the washout intervals for prohibited concomitant medications and prior medications);

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: October 14, 2024
• Primary Completion: April 17, 2025
• Study Completion: July 29, 2025
• Last Updated: April 29, 2026

Record last verified: 2024-12

Locations

CN (1)