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

Vasomotor Symptoms Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06393673
• Other study ID #: HS-10384-201
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 30, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: April 2024
• Source: Hansoh BioMedical R&D Company
• Contact: Qi Yu, MD
• Phone: (+86)13701227034
• Email: yuqimd[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 195
• Est. completion date: September 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Vasomotor Symptoms

Intervention

Drug:
• HS-10384 tablet Dose 1
Administered orally QD
• HS-10384 tablet Dose 2
Administered orally QD
• HS-10384-matched placebo tablets
Administered orally QD

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences (CAMS)Peking Union Medical College (PUMC)	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Hansoh BioMedical R&D Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in the frequency of moderate to severe vasomotor symptoms from baseline to Week 4;		Baseline to Week 4
Primary	Mean change in the frequency of moderate to severe vasomotor symptoms from baseline to Week 12;		Baseline to Week 12
Primary	Mean change in the severity of moderate to severe vasomotor symptoms from baseline to Week 4;		Baseline to Week 4
Primary	Mean change in the severity of moderate to severe vasomotor symptoms from baseline to Week 12.		Baseline to Week 12
Secondary	Mean change in the frequency of moderate and severe vasomotor symptoms from baseline to each study week;		Baseline to Week 15
Secondary	Mean change in the severity of moderate and severe vasomotor symptoms from baseline to each study week;		Baseline to Week 15
Secondary	Mean change in the hot flash score of moderate and severe vasomotor symptoms from baseline to each study week;		Baseline to Week 15
Secondary	Mean percent reduction of 50% and 100% of moderate and severe vasomotor symptoms from baseline to each study week.		Baseline to Week 15
Secondary	Incidence and severity of treatment-emergent adverse events;		Baseline to Week 15
Secondary	Number of participants with clinical laboratory abnormalities;		Baseline to Week 15
Secondary	Number of participants with abnormalities of vital signs		Baseline to Week 15
Secondary	Number of participants with abnormalities of physical examinations		Baseline to Week 15
Secondary	Change from baseline in ECG parameters		Baseline to Week 15
Secondary	Change from baseline in plasma bone density marker concentrations		Baseline to Week 15
Secondary	Change from baseline in Endometrial health assessment.		Baseline to Week 15