Clinical trial NCT01698164: Multi-centre Clinical Trial on Hormone Replacement Treatment in China
Official title: Multi-centre Clinical Trial on Hormone Replacement Treatment in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Menopausal Syndrome
Cardiovascular Disease
Osteoporosis
Breast Cancer
Keywords: lipid profiles
coronary heart disease
menopausal syndrome
MMSE
MENQOL
HAD
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2012-10-02
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from Baseline in risk factors of cardiovascular disease at 12 months and 24 months
timeFrame: before the treatment, time point of taking the medicine for 1 year, time point of taking the medicine for 2 years
measure: Change from Baseline in risk factors of breast cancer at 12 months and 24 months
timeFrame: before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years
Secondary outcomes:
measure: Change from Baseline in BMD at 12 months and 24 months
timeFrame: before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years
measure: Change from Baseline in risk factors of senile dementia every three months
timeFrame: before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later
measure: Change from Baseline in the quality of life every three months
timeFrame: before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later
Other outcomes:
measure: Change from Baseline in thickness of endometrium at 12 months and 24 months
timeFrame: before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years
measure: uterine bleeding
timeFrame: every three months after taking the medicine until two years later
measure: Change from Baseline in vital signs every three months
timeFrame: before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later
measure: Change from Baseline in general health at 12 months and 24 months
timeFrame: before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years
Locations:
city: Peking
country: China
facility: PUMCH
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Aijun Sun, PH.D M.D
role: STUDY_DIRECTOR
References:
citation: 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.