A Study to Find the Best Dose of HS-10384 to Treat Vasomotor Symptoms in Postmenopausal Women

April 27, 2024 updated by: Hansoh BioMedical R&D Company

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
195

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Qi Yu, MD
  • Phone Number: (+86)13701227034
  • Email: yuqimd@163.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 100032
        • Chinese Academy of Medical Sciences (CAMS)Peking Union Medical College (PUMC)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Women between 40 and 65 years old (including extremes);
  2. The body mass index at screening is between 18.5~30 kg/m2 (including extremes)；
  3. 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.);
  4. 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;
  5. The blood pregnancy test of female subjects at baseline period is negative.

Exclusion Criteria:

  1. 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;
  2. Have a history of migraine within 3 months before screening;
  3. Uncontrolled hypertension and a systolic blood pressure ≥140 mmHg and/or a diastolic blood pressure ≥90 mmHg;
  4. Previous or current history of a malignant tumor, except for basal cell carcinoma;
  5. 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;
  6. 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;
  7. 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.;
  8. Participants have participated in any interventional study or taken study drugs within 3 months before screening;
  9. 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.;
  10. 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;
  11. 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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: HS-10384-matched placebo tablets
Administered orally QD
Experimental: HS-10384 Dose 1
Dose level 1 of HS-10384
Drug: HS-10384 tablet Dose 1
Administered orally QD
Drug: HS-10384-matched placebo tablets
Administered orally QD
Experimental: HS-10384 Dose 2
Dose level 2 of HS-10384
Drug: HS-10384-matched placebo tablets
Administered orally QD
Drug: HS-10384 tablet Dose 2
Administered orally QD

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Mean change in the frequency of moderate to severe vasomotor symptoms from baseline to Week 4;
Time Frame: Baseline to Week 4
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
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
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
Baseline to Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Mean change in the frequency of moderate and severe vasomotor symptoms from baseline to each study week;
Time Frame: Baseline to Week 15
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
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
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
Baseline to Week 15
Incidence and severity of treatment-emergent adverse events;
Time Frame: Baseline to Week 15
Baseline to Week 15
Number of participants with clinical laboratory abnormalities;
Time Frame: Baseline to Week 15
Baseline to Week 15
Number of participants with abnormalities of vital signs
Time Frame: Baseline to Week 15
Baseline to Week 15
Number of participants with abnormalities of physical examinations
Time Frame: Baseline to Week 15
Baseline to Week 15
Change from baseline in ECG parameters
Time Frame: Baseline to Week 15
Baseline to Week 15
Change from baseline in plasma bone density marker concentrations
Time Frame: Baseline to Week 15
Baseline to Week 15
Change from baseline in Endometrial health assessment.
Time Frame: Baseline to Week 15
Baseline to Week 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hansoh BioMedical R&D Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HS-10384-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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