Multi-centre Clinical Trial on Hormone Replacement Treatment in China
Phase 4
- Conditions
- Menopausal SyndromeCardiovascular DiseaseOsteoporosisBreast Cancer
- Interventions
- Registration Number
- NCT01698164
- Lead Sponsor
- Peking Union Medical College Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 1200
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description estradiol plus MPA 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 estradiol plus progesterone 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 Ximingting tablet Ximingting Tablet 1 tablet of cimicifuga rhizoma extract, tid 100mg\*15\*2/box The anticipated duration is 2 years.
- Primary Outcome Measures
Name Time Method Change from Baseline in risk factors of cardiovascular disease at 12 months and 24 months 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 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 Outcome Measures
Name Time Method 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 DEXA bone mineral density
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 mini-mental state examination, hospital anxiety and depression scale
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 Kupperman menopause index, RAND36 Menopause-Specific quality of life questionaire
Trial Locations
- Locations (1)
PUMCH
🇨🇳Peking, Beijing, China