Breast Cancer, Cardiovascular Disease, Menopausal Syndrome, Osteoporosis
Conditions
Keywords
lipid profiles, coronary heart disease, menopausal syndrome, MMSE, MENQOL, HAD
Brief summary
This study is to evaluate the benefit/risk of hormone replacement treatment among early menopausal women in China. This is a multi-centre, random, prospective study.
Interventions
DRUGestradiol plus MPA
Participants are given estradiol and synthetic progestin.
DRUGXimingting Tablet
Participants are given phytoestrogen.
DRUGestradiol plus progesterone
Participants are given estradiol and natural progesterone.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* going through amenorrhea above 6 months and within 5 years, * aged 40 to 60 years, * going though postmenopausal symptoms, * serum E2 concentration \<30pg/ml, * serum FSH concentration \>40IU/L.
Exclusion criteria
* uterine fibroid diameter≥5cm, * history of diabetes or hypertension, * history of thromboembolism, severe endometriosis, epilepsy, asthma, hyperprolactinemia, * first degree relative had a history of breast cancer, * being in severe or unstable condition of somatic diseases, * receiving HRT in the past 3 month, * drug or alcohol abuse in the past 3 month, * endometrial thickness ≥0.5cm after withdrawal bleeding, * being allergic to the medicine, * participating in other clinical trials within 1 month ago.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in risk factors of cardiovascular disease at 12 months and 24 months | before the treatment, time point of taking the medicine for 1 year, time point of taking the medicine for 2 years | lipid profiles, high-sensitivity C-reactive protein, Hemoglobin A1C, fasting glucose, fasting insulin, blood pressure, waistline, hipline, body composition, electrocardiogram, incidence of coronary heart disease |
| Change from Baseline in risk factors of breast cancer at 12 months and 24 months | before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years | Mammography, palpation of breast, incidence of breast cancer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in BMD at 12 months and 24 months | before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years | DEXA bone mineral density |
| Change from Baseline in risk factors of senile dementia every three months | before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later | mini-mental state examination, hospital anxiety and depression scale |
| Change from Baseline in the quality of life every three months | before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later | Kupperman menopause index, RAND36 Menopause-Specific quality of life questionaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in vital signs every three months | before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later | height, weight, heart rate, BP, gynecological examination |
| uterine bleeding | every three months after taking the medicine until two years later | diary |
| Change from Baseline in general health at 12 months and 24 months | before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years | liver function, renal function |
| Change from Baseline in thickness of endometrium at 12 months and 24 months | before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years | ultrasonography |
Countries
China
Contacts
Primary ContactTingping Zheng, Bachelor Degree
Outcome results
None listed