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Multi-centre Clinical Trial on Hormone Replacement Treatment in China

Phase 4
40 Years
60 Years
Open (Enrolling)
Menopausal Syndrome, Cardiovascular Disease, Osteoporosis, Breast Cancer

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Trial Information

Multi-centre Clinical Trial on Hormone Replacement Treatment in China

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,

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change from Baseline in risk factors of cardiovascular disease at 12 months and 24 months

Outcome Description:

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

Outcome Time Frame:

before the treatment, time point of taking the medicine for 1 year, time point of taking the medicine for 2 years

Safety Issue:


Principal Investigator

Aijun Sun, PH.D M.D

Investigator Role:

Study Director

Investigator Affiliation:

Peking Union Medical College Hospital


China: Ministry of Health

Study ID:




Start Date:

December 2008

Completion Date:

Related Keywords:

  • Menopausal Syndrome
  • Cardiovascular Disease
  • Osteoporosis
  • Breast Cancer
  • lipid profiles
  • coronary heart disease
  • menopausal syndrome
  • MMSE
  • HAD
  • Breast Neoplasms
  • Cardiovascular Diseases
  • Osteoporosis