Multi-centre Clinical Trial on Hormone Replacement Treatment in China

Study Overview
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Brief Summary
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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.

Official Title
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Multi-centre Clinical Trial on Hormone Replacement Treatment in China

Conditions
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Menopausal Syndrome, Cardiovascular Disease, Osteoporosis, Breast Cancer

Intervention / Treatment
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* Drug: estradiol plus MPA
* Drug: Ximingting Tablet
* Drug: estradiol plus progesterone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: estradiol plus MPA<br>1 mg estradiol valerate, once a day, for 28 days, since the 17th day of taking estradiol valerate adding 4mg medroxyprogesterone acetate, once a day, for 12 days. 28 days forms one cycle. The anticipated duration is 24cycles. estradiol valerate, 1mg*21/box medroxyprogesterone acetate, 2mg*100/bottle | Drug: estradiol plus MPA<br>* Participants are given estradiol and synthetic progestin.<br>|
| Experimental: estradiol plus progesterone<br>1 mg estradiol valerate, once a day, for 28 days, since the 17th day of taking estradiol valerate adding 200mg progesterone capsule, once a day, for 12 days. 28 days forms one cycle. The anticipated duration is 24cycles. estradiol valerate, 1mg*21/box progesterone capsule, 100mg*6/box | Drug: estradiol plus progesterone<br>* Participants are given estradiol and natural progesterone.<br>|
| Experimental: Ximingting tablet<br>1 tablet of cimicifuga rhizoma extract, tid 100mg*15*2/box The anticipated duration is 2 years. | Drug: Ximingting Tablet<br>* Participants are given phytoestrogen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in risk factors of cardiovascular disease at 12 months and 24 months | 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 | before the treatment, time point of taking the medicine for 1 year, time point of taking the medicine for 2 years | 
| Change from Baseline in risk factors of breast cancer at 12 months and 24 months | Mammography, palpation of breast, incidence of breast cancer | before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in BMD at 12 months and 24 months | DEXA bone mineral density | before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years | 
| Change from Baseline in risk factors of senile dementia every three months | mini-mental state examination, hospital anxiety and depression scale | before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later | 
| Change from Baseline in the quality of life every three months | Kupperman menopause index, RAND36 Menopause-Specific quality of life questionaire | before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lipid profiles, coronary heart disease, menopausal syndrome, MMSE, MENQOL, HAD