Overview

Multi-centre Clinical Trial on Hormone Replacement Treatment in China

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Peking Union Medical College Hospital
Treatments:
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Hormones
Medroxyprogesterone Acetate
Polyestradiol phosphate
Progesterone
Criteria
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.