Vasomotor SymptomsPhase 2NCT06393673
A Study to Find the Best Dose of HS-10384 to Treat Vasomotor Symptoms in Postmenopausal Women
A Phase 2 study testing HS-10384 tablet Dose 1 and HS-10384 tablet Dose 2 in people with Vasomotor Symptoms, run by Hansoh BioMedical R&D Company at 1 site in China.
Trial summary
A randomized, double-blind, placebo-controlled phase 2 clinical study to evaluate the efficacy and safety of HS-10384 in postmenopausal women suffering from vasomotor symptoms. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Vasomotor Symptoms
- What is being tested?
- HS-10384 tablet Dose 1 and HS-10384 tablet Dose 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 195 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2024to 30 Sep 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women between 40 and 65 years old (including extremes);
- The body mass index at screening is between 18.5~30 kg/m2 (including extremes)；
- Subjects are postmenopausal women at screening as qualified by any of the following criteria: spontaneous amenorrhea ≥ 12 months, or spontaneous amenorrhea ≥ 6 months and FSH>40 IU/L (without other obvious pathological or physiological reasonsbefore screening), or documented surgical sterilization (such as hysterectomy, bilateral salpingectomy or bilateral oophorectomy, etc.);
- At least 50 moderate to severe vasomotor symptoms per week (ie, 7 consecutive days), or 7 moderate to severe vasomotor symptoms per day (ie, 7 consecutive days) recorded in the daily diary during the screening period;
- The blood pregnancy test of female subjects at baseline period is negative.
Who cannot join
- Participants with disease history of unexplained uterine bleeding, endometrial hyperplasia, ovarian tumor, pituitary tumor, or other diseases evaluated by the principal investigator as not suitable for this study;
- Have a history of migraine within 3 months before screening;
- Uncontrolled hypertension and a systolic blood pressure ≥140 mmHg and/or a diastolic blood pressure ≥90 mmHg;
- Previous or current history of a malignant tumor, except for basal cell carcinoma;
- Participants with clinically significant diseases (such as neuropsychiatric system, cardiovascular system, urinary system, digestive system, respiratory system, skeletal muscle system, endocrine and metabolic system, blood system, skin disease, immune system, tumor, etc.) were evaluated by the researcher as not suitable for this study;
- Within 4 weeks or 5 half-lives (whichever is longer) before taking drug, participants have taken hormonal treatment, hormonal contraceptive or other therapy due to VMS;
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- Within 4 weeks or 5 half-lives (whichever is longer) before screening, and during the whole study period, it is expected to take any medicine and health care products, including prescription drugs, immunomodulator or Chinese herbal medicine, etc.;
- Participants have participated in any interventional study or taken study drugs within 3 months before screening;
- Judged by the Investigator to be unsuited to participate in the study based on findings observed during physical examination, vital sign assessment, or 12-lead electrocardiogram (ECG), et al.;
- Active liver disease or jaundice, or values of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 x the upper limit of normal (ULN); or total bilirubin or direct bilirubin >1.5 x ULN;
- Creatinine >1.5 x ULN; or estimated glomerular filtration rate (eGFR) using the CKD-EPI formula ≤59 mL/min/1.73 sqm at the screening visit;
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese Academy of Medical Sciences (CAMS)Peking Union Medical College (PUMC)
Shanghai, Shanghai Municipality, 100032
Qi Yu, MD, (+86)13701227034, yuqimd@163.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Investigate the Efficacy and Safety of HS-10384 in Postmenopausal Women Suffering From Vasomotor Symptoms (Hot Flashes)
A randomized, double-blind, placebo-controlled phase 2 clinical study to evaluate the efficacy and safety of HS-10384 in postmenopausal women suffering from vasomotor symptoms.
Read the detailed description
The phase 2 study is consisted with 2 doses. The aim is to detect the efficacy, safety, pharmacokinetics and pharmacodynamics characteristics of HS-10384 in participants with vasomotor symptoms.
- Conditions
- Vasomotor Symptoms
- Being tested
- HS-10384 tablet Dose 1, HS-10384 tablet Dose 2, HS-10384-matched placebo tablets
- Keywords
- HS-10384, Vasomotor symptoms, postmenopausal women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10384 tablet Dose 1Drug
Administered orally QD
HS-10384 tablet Dose 2Drug
Administered orally QD
HS-10384-matched placebo tabletsDrug
Administered orally QD
| Study group | Role | What they receive |
|---|---|---|
| HS-10384 Dose 1 | Experimental | Dose level 1 of HS-10384 Receives: Drug: HS-10384 tablet Dose 1; Drug: HS-10384-matched placebo tablets |
| HS-10384 Dose 2 | Experimental | Dose level 2 of HS-10384 Receives: Drug: HS-10384 tablet Dose 2; Drug: HS-10384-matched placebo tablets |
| Placebo | Placebo comparator | Not described Receives: Drug: HS-10384-matched placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in the frequency of moderate to severe vasomotor symptoms from baseline to Week 4;
Measured: Baseline to Week 4
Mean change in the frequency of moderate to severe vasomotor symptoms from baseline to Week 12;
Measured: Baseline to Week 12
Mean change in the severity of moderate to severe vasomotor symptoms from baseline to Week 4;
Measured: Baseline to Week 4
Mean change in the severity of moderate to severe vasomotor symptoms from baseline to Week 12.
Measured: Baseline to Week 12
Secondary outcomes (11)
Mean change in the frequency of moderate and severe vasomotor symptoms from baseline to each study week;
Measured: Baseline to Week 15
Mean change in the severity of moderate and severe vasomotor symptoms from baseline to each study week;
Measured: Baseline to Week 15
Mean change in the hot flash score of moderate and severe vasomotor symptoms from baseline to each study week;
Measured: Baseline to Week 15
Mean percent reduction of 50% and 100% of moderate and severe vasomotor symptoms from baseline to each study week.
Measured: Baseline to Week 15
Incidence and severity of treatment-emergent adverse events;
Measured: Baseline to Week 15
Number of participants with clinical laboratory abnormalities;
Measured: Baseline to Week 15
Number of participants with abnormalities of vital signs
Measured: Baseline to Week 15
Number of participants with abnormalities of physical examinations
Measured: Baseline to Week 15
Change from baseline in ECG parameters
Measured: Baseline to Week 15
Change from baseline in plasma bone density marker concentrations
Measured: Baseline to Week 15
Change from baseline in Endometrial health assessment.
Measured: Baseline to Week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start30 May 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasomotor SymptomsStudies of the same condition, open and under way.
- More trials run by Hansoh BioMedical R&D CompanyThe 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
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hansoh BioMedical R&D Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393673
- Sponsor's protocol ID
- HS-10384-201
- Status last verified
- Apr 2024
- First submitted
- 27 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Investigate the Efficacy and Safety of HS-10384 in Postmenopausal Women Suffering From Vasomotor Symptoms (Hot Flashes)
- ClinicalTrials.gov ID
- NCT06393673
- Acronym / sponsor ID
- HS-10384-201
- Conditions
- Vasomotor Symptoms
- Keywords
- HS-10384, Vasomotor symptoms, postmenopausal women
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Hansoh BioMedical R&D CompanyIndustry (pharma, biotech, devices)
- Study start
- 30 May 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 1 May 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 phase 2 clinical study to evaluate the efficacy and safety of HS-10384 in postmenopausal women suffering from vasomotor symptoms.
Detailed description
The phase 2 study is consisted with 2 doses. The aim is to detect the efficacy, safety, pharmacokinetics and pharmacodynamics characteristics of HS-10384 in participants with vasomotor symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HS-10384 Dose 1 | Experimental | Drug: HS-10384 tablet Dose 1, Drug: HS-10384-matched placebo tabletsDose level 1 of HS-10384 |
| HS-10384 Dose 2 | Experimental | Drug: HS-10384 tablet Dose 2, Drug: HS-10384-matched placebo tabletsDose level 2 of HS-10384 |
| Placebo | Placebo comparator | Drug: HS-10384-matched placebo tablets |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women between 40 and 65 years old (including extremes);
- The body mass index at screening is between 18.5~30 kg/m2 (including extremes)；
- Subjects are postmenopausal women at screening as qualified by any of the following criteria: spontaneous amenorrhea ≥ 12 months, or spontaneous amenorrhea ≥ 6 months and FSH>40 IU/L (without other obvious pathological or physiological reasonsbefore screening), or documented surgical sterilization (such as hysterectomy, bilateral salpingectomy or bilateral oophorectomy, etc.);
- At least 50 moderate to severe vasomotor symptoms per week (ie, 7 consecutive days), or 7 moderate to severe vasomotor symptoms per day (ie, 7 consecutive days) recorded in the daily diary during the screening period;
- The blood pregnancy test of female subjects at baseline period is negative.
Key exclusion criteria (11 listed)
- Participants with disease history of unexplained uterine bleeding, endometrial hyperplasia, ovarian tumor, pituitary tumor, or other diseases evaluated by the principal investigator as not suitable for this study;
- Have a history of migraine within 3 months before screening;
- Uncontrolled hypertension and a systolic blood pressure ≥140 mmHg and/or a diastolic blood pressure ≥90 mmHg;
- Previous or current history of a malignant tumor, except for basal cell carcinoma;
- Participants with clinically significant diseases (such as neuropsychiatric system, cardiovascular system, urinary system, digestive system, respiratory system, skeletal muscle system, endocrine and metabolic system, blood system, skin disease, immune system, tumor, etc.) were evaluated by the researcher as not suitable for this study;
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 |
|---|---|---|
| HS-10384 tablet Dose 1Administered orally QD | Drug | HS-10384 Dose 1 |
| HS-10384 tablet Dose 2Administered orally QD | Drug | HS-10384 Dose 2 |
| HS-10384-matched placebo tabletsAdministered orally QD | Drug | HS-10384 Dose 1, HS-10384 Dose 2, Placebo |
Primary outcome
Mean change in the frequency of moderate to severe vasomotor symptoms from baseline to Week 4;
Time frame: Baseline to Week 4
Mean change in the frequency of moderate to severe vasomotor symptoms from baseline to Week 12;
Time frame: Baseline to Week 12
Mean change in the severity of moderate to severe vasomotor symptoms from baseline to Week 4;
Time frame: Baseline to Week 4
Mean change in the severity of moderate to severe vasomotor symptoms from baseline to Week 12.
Time frame: Baseline to Week 12
11 secondary outcomes
Mean change in the frequency of moderate and severe vasomotor symptoms from baseline to each study week;
Time frame: Baseline to Week 15
Mean change in the severity of moderate and severe vasomotor symptoms from baseline to each study week;
Time frame: Baseline to Week 15
Mean change in the hot flash score of moderate and severe vasomotor symptoms from baseline to each study week;
Time frame: Baseline to Week 15
Mean percent reduction of 50% and 100% of moderate and severe vasomotor symptoms from baseline to each study week.
Time frame: Baseline to Week 15
Incidence and severity of treatment-emergent adverse events;
Time frame: Baseline to Week 15
Number of participants with clinical laboratory abnormalities;
Time frame: Baseline to Week 15
Number of participants with abnormalities of vital signs
Time frame: Baseline to Week 15
Number of participants with abnormalities of physical examinations
Time frame: Baseline to Week 15
Change from baseline in ECG parameters
Time frame: Baseline to Week 15
Change from baseline in plasma bone density marker concentrations
Time frame: Baseline to Week 15
Change from baseline in Endometrial health assessment.
Time frame: Baseline to Week 15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
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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.
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 HS-10384 tablet Dose 1 and HS-10384 tablet Dose 2 in people with Vasomotor Symptoms, run by Hansoh BioMedical R&D Company 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 11 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: status not confirmed, as of the sponsor's last update on 1 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qi Yu, MD ((+86)13701227034, yuqimd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in the frequency of moderate to severe vasomotor symptoms from baseline to Week 4; (time frame: Baseline to Week 4). The study lists 4 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 1 May 2024.