Clinical Study to Evaluate the Efficacy and Safety of GS1-144 Tablets in the Treatment of Moderat… (NCT06726850) | Clinical Trial Compass
CompletedPhase 2
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.
China129 participantsStarted 2024-10-14
Plain-language 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.
Who can participate
Age range40 Years – 64 Years
SexFEMALE
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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 cl…
What they're measuring
1
Changes from baseline in the frequency of moderate to severe VMS at Week 4.
Timeframe: Week 4
2
Changes from baseline in the frequency of moderate to severe VMS at Week 12