Vasomotor SyndromePhase 2NCT06726850
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 Phase 2 study testing GS1-144 in people with Vasomotor Syndrome, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 64 years, women only
- Conditions the study is for
- Vasomotor Syndrome
- What is being tested?
- GS1-144
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 1 siteChina
- Study dates
- 14 Oct 2024to 29 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
- 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;
- 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);
- Having participated in any other clinical trial within 3 months or any clinical study of fezolinetant or other treatments for VMS (except for participants who have not received any investigational product) within 1 year prior to screening, or planning to participate in any other clinical trial;
- Current or prior history of drug use, drug abuse or alcohol abuse;
- Any other conditions that are unsuitable for participating in this study in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: 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.
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.
Read the 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
- Being tested
- Placebo, GS1-144
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Placebo tablet
In the placebo arm, participants will consume a placebo matching GenSci1-144 for 12 consecutive weeks.
GS1-144Drug
In the GS1-144 arm, participants will receive multiple doses of GS1-144 tablets for 12 consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Participants will receive multiple doses of placebo matching GS1-144 tablet for 12 consecutive weeks. Receives: Drug: Placebo |
| GS1-144 tablet | Experimental | Participants will receive multiple doses of GS1-144 tablets for 12 consecutive weeks. Receives: Drug: GS1-144 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 12
Secondary outcomes (2)
Changes from baseline in the severity 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.
Measured: Week 4
Changes from baseline in the severity 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.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start14 Oct 2024
- Primary completion17 Apr 2025
- Study completion29 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasomotor SyndromeStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726850
- Sponsor's protocol ID
- GenSci074-201
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06726850
- Acronym / sponsor ID
- GenSci074-201
- Conditions
- Vasomotor Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 17 Apr 2025 (actual)
- Study completion
- 29 Jul 2025 (actual)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: PlaceboParticipants will receive multiple doses of placebo matching GS1-144 tablet for 12 consecutive weeks. |
| GS1-144 tablet | Experimental | Drug: GS1-144Participants will receive multiple doses of GS1-144 tablets for 12 consecutive weeks. |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: Placebo tabletIn the placebo arm, participants will consume a placebo matching GenSci1-144 for 12 consecutive weeks. | Drug | placebo |
| GS1-144In the GS1-144 arm, participants will receive multiple doses of GS1-144 tablets for 12 consecutive weeks | Drug | GS1-144 tablet |
Primary outcome
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
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.
2 secondary outcomes
Changes from baseline in the severity of moderate to severe VMS at Week 4
Time frame: Week 4
Changes from baseline in the severity of moderate to severe VMS at Week 12
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GS1-144 in people with Vasomotor Syndrome, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in the frequency of moderate to severe VMS at Week 4. (time frame: Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.