Multi-centre Clinical Trial on Hormone Replacement Treatment in China
1 other identifier
interventional
1,200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedFirst Posted
Study publicly available on registry
October 2, 2012
CompletedOctober 2, 2012
September 1, 2012
3.8 years
September 25, 2012
September 28, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (3)
Change from Baseline in BMD at 12 months and 24 months
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
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
before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later
Other Outcomes (4)
Change from Baseline in thickness of endometrium at 12 months and 24 months
before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years
uterine bleeding
every three months after taking the medicine until two years later
Change from Baseline in vital signs every three months
before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later
- +1 more other outcomes
Study Arms (3)
estradiol plus MPA
ACTIVE COMPARATOR1 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
EXPERIMENTAL1 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
EXPERIMENTAL1 tablet of cimicifuga rhizoma extract, tid 100mg\*15\*2/box The anticipated duration is 2 years.
Interventions
Participants are given estradiol and natural progesterone.
Eligibility Criteria
You may qualify if:
- going through amenorrhea above 6 months and within 5 years,
- aged 40 to 60 years,
- going though postmenopausal symptoms,
- serum E2 concentration \<30pg/ml,
- serum FSH concentration \>40IU/L.
You may not qualify if:
- uterine fibroid diameter≥5cm,
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PUMCH
Beijing, Beijing Municipality, 100730, China
Related Publications (1)
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.
PMID: 27900987DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Aijun Sun, PH.D M.D
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 25, 2012
First Posted
October 2, 2012
Study Start
December 1, 2008
Primary Completion
October 1, 2012
Last Updated
October 2, 2012
Record last verified: 2012-09