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Multi-centre Clinical Trial on Hormone Replacement Treatment in China

This study is currently recruiting participants.
Verified September 2012 by Peking Union Medical College Hospital
Sponsor:
Information provided by:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01698164
First received: September 25, 2012
Last updated: September 28, 2012
Last verified: September 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-centre Clinical Trial on Hormone Replacement Treatment in China

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • Change from Baseline in risk factors of cardiovascular disease at 12 months and 24 months [ Time Frame: before the treatment, time point of taking the medicine for 1 year, time point of taking the medicine for 2 years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years ] [ Designated as safety issue: Yes ]
    Mammography, palpation of breast, incidence of breast cancer


Secondary Outcome Measures:
  • Change from Baseline in BMD at 12 months and 24 months [ Time Frame: before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years ] [ Designated as safety issue: No ]
    DEXA bone mineral density

  • Change from Baseline in risk factors of senile dementia every three months [ Time Frame: before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later ] [ Designated as safety issue: No ]
    mini-mental state examination, hospital anxiety and depression scale

  • Change from Baseline in the quality of life every three months [ Time Frame: before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later ] [ Designated as safety issue: No ]
    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 [ Time Frame: before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years ] [ Designated as safety issue: Yes ]
    ultrasonography

  • uterine bleeding [ Time Frame: every three months after taking the medicine until two years later ] [ Designated as safety issue: Yes ]
    diary

  • Change from Baseline in vital signs every three months [ Time Frame: before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later ] [ Designated as safety issue: Yes ]
    height, weight, heart rate, BP, gynecological examination

  • Change from Baseline in general health at 12 months and 24 months [ Time Frame: before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years ] [ Designated as safety issue: Yes ]
    liver function, renal function


Estimated Enrollment: 1200
Study Start Date: December 2008
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698164

Contacts
Contact: Tingping Zheng, Bachelor Degree zhengtingping@gmail.com

Locations
China, Beijing
PUMCH Recruiting
Peking, Beijing, China, 100730
Contact: Wei Xue, Bachelor Degree         xuewei8955@sina.com    
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Study Director: Aijun Sun, PH.D M.D Peking Union Medical College Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01698164     History of Changes
Other Study ID Numbers: 2008BAI57B04
Study First Received: September 25, 2012
Last Updated: September 28, 2012
Health Authority: China: Ministry of Health

Keywords provided by Peking Union Medical College Hospital:
lipid profiles
coronary heart disease
menopausal syndrome
 MMSE
MENQOL
HAD

Additional relevant MeSH terms:
Breast Neoplasms
Cardiovascular Diseases
Osteoporosis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Estradiol
Polyestradiol phosphate
Hormones
Progesterone
Estradiol valerate
 Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Medroxyprogesterone Acetate
Estrogens
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Progestins

ClinicalTrials.gov processed this record on May 23, 2013