The Benefits and Risks of Different Menopausal Hormone Replacement Therapy Regimes in the Treatment of Menopause Syndrome

The Effect and Risk of Conjugated Estrogens Combined With Different Types of Progestin in the Treatment of Menopause Syndrome During Window Phase

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.

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.