A prospective, open-label, randomized controlled clinical trial to compare the benefits and risks of half-dose or standard-dose conjugated equine estrogens(CEE) plus natural progesterone or dydrogesterone in menopausal hormone therapy .
This is a prospective, open-label, randomized controlled clinical trial compare the benefits and risks of half-dose or standard-dose conjugated equine estrogens(CEE) plus natural progesterone or dydrogesterone in menopausal hormone therapy during window phase. 120 Healthy postmenopausal women with intact uterus seeking treatment for menopausal symptoms are enrolled in this study.Participants are randomized into three groups, the CEE 0.3 mg/micronized progesterone (MP) 100 mg group; CEE 0.625 mg/MP 100 mg group; CEE 0.625 mg/dydrogesterone 10 mg group,metabolic parameters,body composition,bone mineral density,breast cancer risk factors and life quality will be measure at baseline,one year and two year intervention.The investigators hypothesize there may be differences of these parameters measured among three groups after intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
CEE 0.625 mg daily/MP 100mg daily for the last 12 days of every 28 days for two years
CEE 0.3 mg daily/MP 100mg daily for the last 12 days of every 28 days for two years
CEE 0.3 mg/dydrogesterone 10mg daily for the last 12 days of every 28 days for two years
Lei Li
Beijing, China/Beiing, China
LDL-cholesterol
Time frame: 5 minutes
body fat mass percentage
DEXA method
Time frame: 5 minutes
breast mammography
Time frame: 5 minutes
glucose
Time frame: 5 minutes
bone mineral density
Time frame: 5 minutes
Mini-mental State Examination score
Questionnaire.The score range is 0-30.Total score greater than or equal to 24 points indicates a normal cognition,below this, scores can indicate cognitive impairment.
Time frame: 5 minutes
HAD scale
questionnaire to evaluate anxiety and depression.The total score is 0-20.Total score 0-7 is normal,8-10 maybe borderline anxiety or depression,11-20 indicates obvious anxiety or depression.
Time frame: 5 minutes
modified Kupperman score
questionnaire to evaluate the menopause symptom.The total score range is 0-63.Total score below 6 is normal,6-15 is mild,16-30 is moderate, above 30 is severe
Time frame: 5 minutes
Endometrial thickness
ultrasound
Time frame: 5 minutes
weight
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Time frame: 5 minutes
serum creatinine
Time frame: 5 minutes
serum glutamic pyretic transaminase
Time frame: 5 minutes