Menopause Syndrome
Conditions
Keywords
Menopause Syndrome, low dose estrogen, progestin
Brief summary
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 .
Detailed description
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.
Interventions
DRUGCEE 0.625 mg/MP 100mg
CEE 0.625 mg daily/MP 100mg daily for the last 12 days of every 28 days for two years
DRUGCEE 0.3 mg/MP 100mg
CEE 0.3 mg daily/MP 100mg daily for the last 12 days of every 28 days for two years
DRUGCEE 0.625mg/dydrogesterone
CEE 0.3 mg/dydrogesterone 10mg daily for the last 12 days of every 28 days for two years
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomly assigned to three groups: 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.
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. 40 and 60 years old; 2. natural amenorrhea for more than 6 months but less than 5 years; 3. suffered by menopause symptoms and seeking for treatment; 4. serum follicle-stimulating hormone levels \>40 IU/L and serum estradiol \<30 pg/ml.
Exclusion criteria
1. contraindications for menopausal hormone therapy; 2. complications including: uterine myoma more than 3 centimeter in diameter, endometriosis, uncontrolled hypertension or diabetes mellitus, thromboembolic disease history or high risk for developing thromboembolic disease, epilepsy, asthma, hyperprolactinemia, first degree relative has breast cancer; 3. cardiovascular, chronic liver, thyroid or kidney diseases; a history of cancer; a disease or condition that could influence the participants' ability to follow the study protocol; 4. alcohol or drug abuse within the last 3 months; 5. use of hormone therapy in the past 3months; 6. endometrial thickness more than 5mm even after progestin withdrawal; 7. abnormal cervical scraping smear; 8. allergic to any ingredient of the drugs; 9. participation in other clinical trials within the last 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| body fat mass percentage | 5 minutes | DEXA method |
| breast mammography | 5 minutes | — |
| LDL-cholesterol | 5 minutes | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| bone mineral density | 5 minutes | — |
| modified Kupperman score | 5 minutes | 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 |
| Endometrial thickness | 5 minutes | ultrasound |
| Mini-mental State Examination score | 5 minutes | 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. |
| serum creatinine | 5 minutes | — |
| serum glutamic pyretic transaminase | 5 minutes | — |
| weight | 5 minutes | — |
| HAD scale | 5 minutes | 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. |
| glucose | 5 minutes | — |
Countries
China
Outcome results
None listed