Cerebral small vessel diseases
Conditions
Interventions
Control group:placebo
Treatment group:Estradiol gel 2.5g qd for external use, combined with oral progesterone capsule 100mg qd, for 1 year
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
Female
Age
40 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1) Female, aged >= 40 years and = 1 year, = 35mIU /ml, E2 <= 25pg/ml; 4) Head MRI shows lesions, and one of the following items is sufficient: White matter hypersignalling, Fazekas score =2; Fazekas score =1 and has two or more vascular risk factors (hypertension, hyperlipidemia, diabetes, obesity, current smoking, history of vasogenic events other than stroke); Fazekas score =1 combined with old subcortical lacunar infarction. 5) Independence of daily life (MRS <=1); 6) Signing the informed consent.
Exclusion criteria
Exclusion criteria: 1. Estrogen-containing drugs, Traditional Chinese medicine and phytoestrogens (e.g. soy concentrate or extract, Kuntai capsule, Remifemin, etc.) were used in the first 3 months of enrollment. Foods containing soybeans (e.g. tofu, soy milk) are allowed. 2. Active venous and arterial thromboembolic diseases, such as deep venous thrombosis, pulmonary embolism, myocardial infarction, angina or congestive heart failure, stroke, etc. within 6 months before enrollment (transient ischemic attack can be enrolled). 3. Other neurological diseases, such as brain tumors, brain trauma, history of craniocerebral surgery, and: a) Head MRI DWI display: old and new massive infarction (definition: greater than 1/3 of the blood supply area of the middle cerebral artery, or greater than 1/3 of the volume of the cerebellar hemisphere, or the ASPECT DWI score less than 7 points (out of 14); b) Dementia due to brain damage caused by confirmed neurodegenerative diseases (e.g., AD, PD); c) There are clear non-vascular white matter lesions, such as multiple sclerosis, adult white matter dysplasia, metabolic encephalopathy, etc. d) Previous history of cerebral vascular malformation or aneurysmal subarachnoid hemorrhage, or untreated aneurysm (diameter > 3mm). 4. Known or suspected to have breast cancer, endometrial cancer, cervical adenocarcinoma and other hormone-dependent malignant tumors, currently suffering from meningioma, and other malignant tumors are under treatment; 5. Hypertension is still difficult to control after standard treatment, BP > 160/100mmHg; Type 2 diabetes is still difficult to control after standard treatment, hemoglobin a1c > 7mmol/l; Active stage of immune system disease, TSH>10miu/ml or TSH 5cm, or endometrial thickness of > 5mm (those with benign lesions can be included if confirmed by pathology). 9. Other conditions not suitable for menopausal hormone therapy (SLCO1B1 gene positive persons cannot participate in oral estrogen group); 10. Mental disorders diagnosed according to THE DSM-V diagnostic criteria, or previous mental system disorders that fail to communicate adequately; 11. Expected survival time <5 years with severe organic disease, such as malignancy; 12. MRI contraindications (e.g., claustrophobia); 13. The follow-up could not be completed due to regional or other reasons; 14. Participating in other interventional clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of cognitive function;Improvement of mood disorder;Inflammatory Marke;heart rate variability;gut microbiota;Urological and intestinal functions; | — |
Countries
China
Contacts
Public ContactHui Gao
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed