Multi-centre Clinical Trial on Hormone Replacement Treatment in China

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.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Disease; Breast Cancer; Osteoporosis; Menopausal Syndrome
• Intervention / Treatment: Drug: estradiol plus MPA; Drug: estradiol plus progesterone; Drug: Ximingting Tablet

• Study Type: Interventional
• Enrollment (Anticipated): 1200
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Peking, Beijing, China, 100730
      • Recruiting
      • PUMCH
      • Contact: Wei Xue, Bachelor Degree; Email: xuewei8955@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
uterine bleeding	diary	every three months after taking the medicine until two years later
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
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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Director: Aijun Sun, PH.D M.D, Peking Union Medical College Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Anticipated): October 1, 2012

Study Registration Dates

• First Submitted: September 25, 2012
• First Submitted That Met QC Criteria: September 28, 2012
• First Posted (Estimate): October 2, 2012

Study Record Updates

• Last Update Posted (Estimate): October 2, 2012
• Last Update Submitted That Met QC Criteria: September 28, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: coronary heart disease; lipid profiles; MMSE; menopausal syndrome; MENQOL; HAD
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Cardiovascular Diseases; Osteoporosis; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Progestins; Estradiol; Progesterone; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Polyestradiol phosphate
• Other Study ID Numbers: 2008BAI57B04