Perimenopausal syndrome associated with metabolic disorders
Conditions
Interventions
Sangzhi Alkaloids Group:Sangzhi Alkaloids Tablets
Menopausal Hormone Therapy Group:Femoston 2/10
Combination Therapy Group:Sangzhi Alkaloids Plus Menopausal Hormone Therapy
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
Female
Age
40 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Female aged 40–55 years; 2.Amenorrhea for 6 months to 5 years; 3.Diagnosis of perimenopausal syndrome; 4.Modified Kupperman score >= 10; 5.Written informed consent provided;
Exclusion criteria
Exclusion criteria: 1. Uterine fibroids >=3 cm in diameter; 2. Endometriosis with significant clinical symptoms or signs; 3. Diagnosed diabetes mellitus or hypertension; 4. History of thromboembolic disease or predisposition to thrombosis; 5. Epilepsy, asthma, or hyperprolactinemia; 6. First-degree family history of breast cancer; 7. ALT or AST >2 times the upper limit of normal, or serum creatinine >1.5 times the upper limit of normal; 8. Uncontrolled hypertension (SBP >=160 mmHg or DBP >=100 mmHg); 9. Severe cardiovascular, respiratory, gastrointestinal, neurological, immunological, or hematological diseases; 10. Use of estrogen preparations or menopause-related health products within the previous 3 months; 11. Endometrial thickness >=0.5 cm after drug withdrawal or abnormal cervical cytology (except inflammation); 12. Known allergy to the study medications; 13. Participation in another clinical trial within 1 month prior to enrollment; 14. History of alcohol or substance abuse/dependence within the previous 3 months; 15. Any other condition considered unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Kupperman Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Outcomes;Follicle-Stimulating Hormone and Estradiol;Fasting Blood Glucose;Menopause-Specific Quality of Life Questionnaire; | — |
Countries
China
Contacts
Public ContactSun Aijun
Peking Union Medical College Hospital
Outcome results
None listed