Multi-centre Clinical Trial on Hormone Replacement Treatment in China
NCT ID: NCT01698164
Last Updated: 2012-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
1200 participants
INTERVENTIONAL
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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estradiol plus MPA
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 MPA
Participants are given estradiol and synthetic progestin.
estradiol plus progesterone
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
estradiol plus progesterone
Participants are given estradiol and natural progesterone.
Ximingting tablet
1 tablet of cimicifuga rhizoma extract, tid 100mg\*15\*2/box The anticipated duration is 2 years.
Ximingting Tablet
Participants are given phytoestrogen.
Interventions
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estradiol plus MPA
Participants are given estradiol and synthetic progestin.
Ximingting Tablet
Participants are given phytoestrogen.
estradiol plus progesterone
Participants are given estradiol and natural progesterone.
Eligibility Criteria
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Inclusion Criteria
* aged 40 to 60 years,
* going though postmenopausal symptoms,
* serum E2 concentration \<30pg/ml,
* serum FSH concentration \>40IU/L.
Exclusion Criteria
* history of diabetes or hypertension,
* history of thromboembolism, severe endometriosis, epilepsy, asthma, hyperprolactinemia,
* first degree relative had a history of breast cancer,
* being in severe or unstable condition of somatic diseases,
* receiving HRT in the past 3 month,
* drug or alcohol abuse in the past 3 month,
* endometrial thickness ≥0.5cm after withdrawal bleeding,
* being allergic to the medicine,
* participating in other clinical trials within 1 month ago.
40 Years
60 Years
FEMALE
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Principal Investigators
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Aijun Sun, PH.D M.D
Role: STUDY_DIRECTOR
Peking Union Medical College Hospital
Locations
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PUMCH
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Wei Xue, Bachelor Degree
Role: primary
References
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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.
Other Identifiers
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2008BAI57B04
Identifier Type: -
Identifier Source: org_study_id