Multi-centre Clinical Trial on Hormone Replacement Treatment in China

Breast Cancer Clinical Trial

Official title:

Multi-centre Clinical Trial on Hormone Replacement Treatment in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01698164
• Other study ID #: 2008BAI57B04
• Status: Recruiting
• Phase: Phase 4
• First received: September 25, 2012
• Last updated: September 28, 2012
• Start date: December 2008

Study information

• Verified date: September 2012
• Source: Peking Union Medical College Hospital
• Contact: Tingping Zheng, Bachelor Degree
• Email: zhengtingping[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Cardiovascular Disease
• Cardiovascular Diseases
• Menopausal Syndrome
• Osteoporosis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	PUMCH	Peking	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from Baseline in thickness of endometrium at 12 months and 24 months	ultrasonography	before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years	Yes
Other	uterine bleeding	diary	every three months after taking the medicine until two years later	Yes
Other	Change from Baseline in vital signs every three months	height, weight, heart rate, BP, gynecological examination	before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later	Yes
Other	Change from Baseline in general health at 12 months and 24 months	liver function, renal function	before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	Change from Baseline in BMD at 12 months and 24 months	DEXA bone mineral density	before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years	No
Secondary	Change from Baseline in risk factors of senile dementia every three months	mini-mental state examination, hospital anxiety and depression scale	before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later	No
Secondary	Change from Baseline in the quality of life every three months	Kupperman menopause index, RAND36 Menopause-Specific quality of life questionaire	before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later	No