Multi-centre Clinical Trial on Hormone Replacement Treatment in China

This study is currently recruiting participants. (see Contacts and Locations)
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

September 25, 2012
September 28, 2012
December 2008
October 2012   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01698164 on ClinicalTrials.gov Archive Site
  • 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
Same as current
  • 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
Same as current
 
Multi-centre Clinical Trial on Hormone Replacement Treatment in China
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Menopausal Syndrome
  • Cardiovascular Disease
  • Osteoporosis
  • Breast Cancer
  • Drug: estradiol plus MPA
    Participants are given estradiol and synthetic progestin.
  • Drug: Ximingting Tablet
    Participants are given phytoestrogen.
  • Drug: estradiol plus progesterone
    Participants are given estradiol and natural progesterone.
  • 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

    Intervention: Drug: estradiol plus MPA
  • 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

    Intervention: Drug: estradiol plus progesterone
  • Experimental: Ximingting tablet
    1 tablet of cimicifuga rhizoma extract, tid 100mg*15*2/box The anticipated duration is 2 years.
    Intervention: Drug: Ximingting Tablet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1200
Not Provided
October 2012   (final data collection date for primary outcome measure)

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.
Female
40 Years to 60 Years
No
Contact: Tingping Zheng, Bachelor Degree zhengtingping@gmail.com
China
 
NCT01698164
2008BAI57B04
Not Provided
Not Provided
Peking Union Medical College Hospital
Not Provided
Study Director: Aijun Sun, PH.D M.D Peking Union Medical College Hospital
Peking Union Medical College Hospital
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP