Menopause-related symptoms
Conditions
Interventions
Nilestriol group:Nilestriol Tablets (Weini'an) + Dydrogesterone Tablets (Duphaston)
Estradiol Valerate group:Estradiol Valerate Tablets (Progynova) + Dydrogesterone Tablets (Duphaston)
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
Female
Age
40 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. 40= Age =60, female. 2. Meet any of the following conditions: 1) Natural amenorrhea for at least 12 months, serum estradiol 40 IU/L. 2) Bilateral oophorectomy has been completed for at least 6 weeks before screening. 3. Obvious menopause related symptoms, modified Kupperman index =16. 4. Fully informed consent, participate in the study voluntarily and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Known or suspected pregnancy. 2. Vaginal bleeding of unknown cause. 3. Known or suspected to suffer from hormone dependent precancerous lesions and malignant tumor (e.g. endometrial cancer, endometrial atypical hyperplasia). 4. Known or suspected to have arterial and venous thromboembolism in recent 6 months (e.g. myocardial infarction, deep vein thrombosis, pulmonary embolism) 5. High risk factors for venous or arterial thrombosis (BMI>30, smoking, family history of thrombophilia) 6. Oral, injected, transvaginal or percutaneous Estrogen or progesterone preparations were taken within 4 weeks before enrollment. Estrogen or progesterone preparations were implanted before enrollment. 7. Non-hormonal drugs, such as Chinese patent drugs (e.g. Kuntai Capsules, Xiangshao Granules), botanical drugs (e.g. black cohosh), phytoestrogens (e.g. soybean progesterone, coumarins, fungal estrogen), anxiolytics, antidepressants and sleep aid drugs were taken within 4 weeks before enrollment. 8. Drugs that affect drug metabolism (e.g. phenytoin, phenobarbital, carbamazepine, rifampicin, tricyclic antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotic drugs, verapamil, fluoroquinolones, antihistamines) were taken within 1 month before enrollment. 9. Severe liver and/or kidney insufficiency (Includeding any of the following parameters: AST/ALT/GGT >2 times of upper limit of normal value, ALP >1.5 times of upper limit of normal value, creatinine >1.25 times of upper limit of normal value). 10. Poor blood pressure control (systolic pressure =160 mmHg and/or diastolic pressure =100 mmHg). 11. Alcohol abuse (>20g for daily drinking, alcohol intake = alcohol consumption [ml] × Alcohol concentration [%] × 0.8), smoking (current smoking habit, >5 cigarettes per day), history of narcotics, anesthetics and other drugs abuse. 12. Unable to complete the research process for any reason, such as language understanding problems, mental disease, unable to visit the research center, etc. 13. Allergic constitution, Known or suspected hypersensitivity to investigational drug ingredients 14. Participated or participating in other clinical trials in the last month. 15. Not suitable to participate in this clinical study according to the judgment of the investigator, such as heart failure, pheochromocytoma, liver tumor, porphyria, systemic lupus erythematosus, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Kupperman Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Kupperman Index;Symptom efficacy based on Modified Kupperman Index (total effective rate, cure rate, significant effective rate and effective rate);Hot flashes score (hot flashes in Modified Kupperman Index);Serum sex hormones (FSH, LH, E2);MENQOL questionnaire;maturation value of vaginal exfoliated cells;Serum bone turnover markers (B-ALP, T-PINP, ß-CTX); | — |
Countries
China
Contacts
Public ContactYu Qi
Peking Union Medical College Hospital
Outcome results
None listed