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Multi-centre Clinical Trial on Hormone Replacement Treatment in China

Primary Purpose

Menopausal Syndrome, Cardiovascular Disease, Osteoporosis

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

estradiol plus MPA

Ximingting Tablet

estradiol plus progesterone

About this trial

This is an interventional treatment trial for Menopausal Syndrome focused on measuring lipid profiles, coronary heart disease, menopausal syndrome, MMSE, MENQOL, HAD

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

PUMCHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

estradiol plus MPA

estradiol plus progesterone

Ximingting tablet

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Change from Baseline in risk factors of breast cancer at 12 months and 24 months

Mammography, palpation of breast, incidence of breast cancer

Secondary Outcome Measures

Change from Baseline in BMD at 12 months and 24 months

DEXA bone mineral density

Change from Baseline in risk factors of senile dementia every three months

mini-mental state examination, hospital anxiety and depression scale

Change from Baseline in the quality of life every three months

Kupperman menopause index, RAND36 Menopause-Specific quality of life questionaire

Full Information

NCT ID

NCT01698164

First Posted

September 25, 2012

Last Updated

September 28, 2012

Sponsor

Peking Union Medical College Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01698164

Brief Title

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

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Unknown status

Study Start Date

December 2008 (undefined)

Primary Completion Date

October 2012 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Peking Union Medical College Hospital

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Menopausal Syndrome, Cardiovascular Disease, Osteoporosis, Breast Cancer

Keywords

lipid profiles, coronary heart disease, menopausal syndrome, MMSE, MENQOL, HAD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

estradiol plus MPA

Arm Type

Active Comparator

Arm Description

Arm Title

estradiol plus progesterone

Arm Type

Experimental

Arm Description

Arm Title

Ximingting tablet

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

estradiol plus MPA

Intervention Description

Participants are given estradiol and synthetic progestin.

Intervention Type

Drug

Intervention Name(s)

Ximingting Tablet

Intervention Description

Participants are given phytoestrogen.

Intervention Type

Drug

Intervention Name(s)

estradiol plus progesterone

Intervention Description

Participants are given estradiol and natural progesterone.

Primary Outcome Measure Information:

Title

Change from Baseline in risk factors of cardiovascular disease at 12 months and 24 months

Description

Time Frame

before the treatment, time point of taking the medicine for 1 year, time point of taking the medicine for 2 years

Title

Change from Baseline in risk factors of breast cancer at 12 months and 24 months

Description

Mammography, palpation of breast, incidence of breast cancer

Time Frame

before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years

Secondary Outcome Measure Information:

Title

Change from Baseline in BMD at 12 months and 24 months

Description

DEXA bone mineral density

Time Frame

before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years

Title

Change from Baseline in risk factors of senile dementia every three months

Description

mini-mental state examination, hospital anxiety and depression scale

Time Frame

before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later

Title

Change from Baseline in the quality of life every three months

Description

Kupperman menopause index, RAND36 Menopause-Specific quality of life questionaire

Time Frame

before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later

Other Pre-specified Outcome Measures:

Title

Change from Baseline in thickness of endometrium at 12 months and 24 months

Description

ultrasonography

Time Frame

before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years

Title

uterine bleeding

Description

diary

Time Frame

every three months after taking the medicine until two years later

Title

Change from Baseline in vital signs every three months

Description

height, weight, heart rate, BP, gynecological examination

Time Frame

before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later

Title

Change from Baseline in general health at 12 months and 24 months

Description

liver function, renal function

Time Frame

before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tingping Zheng, Bachelor Degree

zhengtingping@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aijun Sun, PH.D M.D

Organizational Affiliation

Peking Union Medical College Hospital

Official's Role

Study Director

Facility Information:

Facility Name

PUMCH

City

Peking

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wei Xue, Bachelor Degree

xuewei8955@sina.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

27900987

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.

Results Reference

derived

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Multi-centre Clinical Trial on Hormone Replacement Treatment in China

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