Multi-centre Clinical Trial on Hormone Replacement Treatment in China

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 4

Conditions: Osteoporosis; Breast Cancer; Menopausal Syndrome; Cardiovascular Disease

Treatments: Drug: estradiol plus progesterone; Drug: estradiol plus MPA; Drug: Ximingting Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT01698164

2008BAI57B04

Details and patient eligibility

About

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.

Enrollment: 1,200 estimated patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,200 participants in 3 patient groups

estradiol plus MPA

Active Comparator group

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

Treatment:

Drug: estradiol plus MPA

estradiol plus progesterone

Experimental group

Description:

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

Treatment:

Drug: estradiol plus progesterone

Ximingting tablet

Experimental group

Description:

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

Treatment:

Drug: Ximingting Tablet