Menopause disease
Conditions
Interventions
experimental group:Estradiol Tablets/Estradiol and Dydrogesterone Tablets (Femoston 1/10). Take 1 tablet orally every day. The total course of treatment was 24 weeks.
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
Female
Age
42 Years to 52 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 42-52 years; 2. Have a complete uterus and bilateral ovaries; 3. The difference in the length of adjacent menstrual cycles is greater than or equal to 7 days, repeated in 10 menstrual cycles, and at least one menstrual cramp in the past 1 year; 4. Obvious symptoms of menopause, and the menopausal symptom scale (modified Kupperman score) is greater than or equal to 14 points; 5. Normal TCT test results within one year or normal TCT and HPV test results within three years; 6. Subjects gave full informed consent, voluntarily participated in this study, and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with various malignant tumors or suspicious malignant tumors (the results of tumor marker examination or breast ultrasound and pelvic ultrasound suggest suspicious malignant tumors); 2. History of thrombosis within 6 months; 3. The use of sex hormone drugs (including various estrogen-containing drugs, compound oral contraceptives, etc.) that affect ovarian function in the past 2 months; 4. Those who have used traditional Chinese medicine or botanical medicines (such as Kuntai Capsules, Xiangshao Granules, Lifumin, etc. or similar medicines) that affect menopausal symptoms, as well as anti-anxiety and depression medicines and Western medicines that help sleep in the past 2 months; 5. Transaminase (ALT) and creatinine (Cr) are more than 2 times the normal value; 6. Uterine fibroids >= 5cm; 7. Body mass index BMI >= 28 kg/m2; 8. Subjects who are participating in other clinical trials or have participated in other clinical trials within 3 months; 9. Other conditions that the doctor considers inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of Modified Kupperman score; | — |
Secondary
| Measure | Time frame |
|---|---|
| The simultaneous changes of microbiota in multiple parts of the body after 28, 84, and 168 days of treatment.;Changes in sleep scores, depression and anxiety scales, and sexual function scales from baseline after 28, 84, and 168 days of treatment.;Changes of sex hormone levels, blood lipids and blood glucose before and after treatment.;Changes of metabolites before and after treatment.; | — |
Countries
China
Contacts
Public ContactZhu Lan
Chinese Academy of Medical Sciences Peking Union Medical College Hospital
Outcome results
None listed