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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| estradiol plus MPA | Active Comparator | 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 | Experimental | 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 | Experimental | 1 tablet of cimicifuga rhizoma extract, tid 100mg*15*2/box The anticipated duration is 2 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| estradiol plus MPA | Drug | Participants are given estradiol and synthetic progestin. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in risk factors of cardiovascular disease at 12 months and 24 months | 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 | before the treatment, time point of taking the medicine for 1 year, time point of taking the medicine for 2 years |
| Change from Baseline in risk factors of breast cancer at 12 months and 24 months | Mammography, palpation of breast, incidence of breast cancer | before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in BMD at 12 months and 24 months | DEXA bone mineral density | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in thickness of endometrium at 12 months and 24 months | ultrasonography | before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years |
| uterine bleeding |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tingping Zheng, Bachelor Degree | Contact | zhengtingping@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Aijun Sun, PH.D M.D | Peking Union Medical College Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PUMCH | Recruiting | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27900987 | Derived | Xue W, Deng Y, Wang YF, Sun AJ. Effect of Half-dose and Standard-dose Conjugated Equine Estrogens Combined with Natural Progesterone or Dydrogesterone on Components of Metabolic Syndrome in Healthy Postmenopausal Women: A Randomized Controlled Trial. Chin Med J (Engl). 2016 Dec 5;129(23):2773-2779. doi: 10.4103/0366-6999.194646. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D010024 | Osteoporosis |
| D001943 | Breast Neoplasms |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D004958 | Estradiol |
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Ximingting Tablet |
| Drug |
Participants are given phytoestrogen. |
|
| estradiol plus progesterone | Drug | Participants are given estradiol and natural progesterone. |
|
mini-mental state examination, hospital anxiety and depression scale |
| 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 | Kupperman menopause index, RAND36 Menopause-Specific quality of life questionaire | before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later |
diary
| every three months after taking the medicine until two years later |
| Change from Baseline in vital signs every three months | height, weight, heart rate, BP, gynecological examination | before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later |
| Change from Baseline in general health at 12 months and 24 months | liver function, renal function | before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years |
| D009750 |
| Nutritional and Metabolic Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D011083 |
| Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D003339 | Corpus Luteum Hormones |
| D045167 | Progesterone Congeners |