NCT06726850

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.

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 40 Years – 64 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
DRUG	Placebo	In the placebo arm, participants will consume a placebo matching GenSci1-144 for 12 consecutive weeks.
DRUG	GS1-144	In the GS1-144 arm, participants will receive multiple doses of GS1-144 tablets for 12 consecutive weeks

Timeline

• Start date: 2024-10-14
• Primary completion: 2025-04-17
• Completion: 2025-07-29
• First posted: 2024-12-10
• Last updated: 2026-01-12

Locations

1 site across 1 country: China