Multi-centre Clinical Trial on Hormone Replacement Treatment in China
Overview
- Phase
- Phase 4
- Intervention
- estradiol plus MPA
- Conditions
- Menopausal Syndrome
- Sponsor
- Peking Union Medical College Hospital
- Enrollment
- 1200
- Locations
- 1
- Primary Endpoint
- Change from Baseline in risk factors of cardiovascular disease at 12 months and 24 months
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility 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.
Arms & Interventions
estradiol plus MPA
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
Intervention: estradiol plus MPA
estradiol plus progesterone
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
Intervention: estradiol plus progesterone
Ximingting tablet
1 tablet of cimicifuga rhizoma extract, tid 100mg\*15\*2/box The anticipated duration is 2 years.
Intervention: Ximingting Tablet
Outcomes
Primary Outcomes
Change from Baseline in risk factors of cardiovascular disease at 12 months and 24 months
Time Frame: 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
Time Frame: 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 Outcomes
- 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)
- 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)
- 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)