Multi-centre Clinical Trial on Hormone Replacement Treatment in China

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01698164

Collaborator

(none)

1,200

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Menopausal Syndrome Cardiovascular Disease Osteoporosis Breast Cancer	Drug: estradiol plus MPA Drug: Ximingting Tablet Drug: estradiol plus progesterone	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Multi-centre Clinical Trial on Hormone Replacement Treatment in China

Study Start Date :

Dec 1, 2008

Anticipated Primary Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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, 1mg21/box medroxyprogesterone acetate, 2mg100/bottle	Drug: estradiol plus MPA Participants are given estradiol and synthetic progestin.
Experimental: 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, 1mg21/box progesterone capsule, 100mg6/box	Drug: estradiol plus progesterone Participants are given estradiol and natural progesterone.
Experimental: Ximingting tablet 1 tablet of cimicifuga rhizoma extract, tid 100mg152/box The anticipated duration is 2 years.	Drug: Ximingting Tablet Participants are given phytoestrogen.

Arm

Intervention/Treatment

Active Comparator: 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

Drug: estradiol plus MPA

Participants are given estradiol and synthetic progestin.

Experimental: 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

Drug: estradiol plus progesterone

Participants are given estradiol and natural progesterone.

Experimental: Ximingting tablet

1 tablet of cimicifuga rhizoma extract, tid 100mg*15*2/box The anticipated duration is 2 years.

Drug: Ximingting Tablet

Participants are given phytoestrogen.

Outcome Measures

Primary Outcome Measures

Change from Baseline in risk factors of cardiovascular disease at 12 months and 24 months [before the treatment, time point of taking the medicine for 1 year, time point of taking the medicine for 2 years]
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
Change from Baseline in risk factors of breast cancer 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]
Mammography, palpation of breast, incidence of breast cancer

Secondary Outcome Measures

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]
DEXA bone mineral density
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]
mini-mental state examination, hospital anxiety and depression scale
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]
Kupperman menopause index, RAND36 Menopause-Specific quality of life questionaire

Other Outcome Measures

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]
ultrasonography
uterine bleeding [every three months after taking the medicine until two years later]
diary
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]
height, weight, heart rate, BP, gynecological examination
Change from Baseline in general health 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]
liver function, renal function

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.