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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CEE 0.625 mg/MP 100mg | Experimental | CEE 0.625 mg/micronized progesterone (MP) 100 mg daily for the last 12 days of every 28 days for two years |
|
| CEE 0.3 mg/MP 100mg | Experimental | CEE 0.3mg/micronized progesterone (MP) 100 mg daily for the last 12 days of every 28 days for two years |
|
| CEE 0.625 mg/dydrogesterone 10mg | Experimental | CEE 0.625 mg/dydrogesterone 10 mg daily for the last 12 days of every 28 days for two years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CEE 0.625 mg/MP 100mg | Drug | CEE 0.625 mg daily/MP 100mg daily for the last 12 days of every 28 days for two years |
|
| Measure | Description | Time Frame |
|---|---|---|
| LDL-cholesterol | 5 minutes | |
| body fat mass percentage | DEXA method | 5 minutes |
| breast mammography | 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| glucose | 5 minutes | |
| bone mineral density | 5 minutes | |
| Mini-mental State Examination score |
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Inclusion Criteria:
Exclusion Criteria:
female
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| Name | Affiliation | Role |
|---|---|---|
| Aijun Sun, MD | Peking Union Medical College Hospital,Peking Union Medical College, Chinese Academy of Medicine Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lei Li | Beijing | China/Beiing | 100000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17689624 | Background | Thorneycroft IH, Lindsay R, Pickar JH. Body composition during treatment with conjugated estrogens with and without medroxyprogesterone acetate: analysis of the women's Health, Osteoporosis, Progestin, Estrogen (HOPE) trial. Am J Obstet Gynecol. 2007 Aug;197(2):137.e1-7. doi: 10.1016/j.ajog.2007.05.042. | |
| 15252707 | Background |
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Network platform, and the website will be attached later.
Within 2 months after the trial complete
Data access requests will be reviewed by an external independent review panel.Requestors will be required to sign a Data Access Agreement.
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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.
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| CEE 0.3 mg/MP 100mg | Drug | CEE 0.3 mg daily/MP 100mg daily for the last 12 days of every 28 days for two years |
|
| CEE 0.625mg/dydrogesterone | Drug | CEE 0.3 mg/dydrogesterone 10mg daily for the last 12 days of every 28 days for two years |
|
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.
| 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. | 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 | 5 minutes |
| Endometrial thickness | ultrasound | 5 minutes |
| weight | 5 minutes |
| serum creatinine | 5 minutes |
| serum glutamic pyretic transaminase | 5 minutes |
| Margolis KL, Bonds DE, Rodabough RJ, Tinker L, Phillips LS, Allen C, Bassford T, Burke G, Torrens J, Howard BV; Women's Health Initiative Investigators. Effect of oestrogen plus progestin on the incidence of diabetes in postmenopausal women: results from the Women's Health Initiative Hormone Trial. Diabetologia. 2004 Jul;47(7):1175-1187. doi: 10.1007/s00125-004-1448-x. Epub 2004 Jul 14. |
| ID | Term |
|---|---|
| C031278 | 2-chloroethyl ethyl sulfide |
| D004394 | Dydrogesterone |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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