Multi-centre Clinical Trial on Hormone Replacement Treatment in China

Peking Union Medical College Hospital1,200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,200

Conditions

Menopausal Syndrome Cardiovascular Disease Osteoporosis Breast Cancer

Interventions

estradiol plus MPADRUG

Participants are given estradiol and synthetic progestin.

Ximingting TabletDRUG

Participants are given phytoestrogen.

estradiol plus progesteroneDRUG

Participants are given estradiol and natural progesterone.

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

PUMCH

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years

Secondary Outcomes

Change from Baseline in BMD at 12 months and 24 months

DEXA bone mineral density

Time frame: 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

Time frame: 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

Time frame: before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later

Central Contacts

Tingping Zheng, Bachelor Degree

CONTACT

zhengtingping@gmail.com

Data from ClinicalTrials.gov

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