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The Benefits and Risks of Different Menopausal Hormone Replacement Therapy Regimes in the Treatment of Menopause Syndrome

Primary Purpose

Menopause Syndrome

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
CEE 0.625 mg/MP 100mg
CEE 0.3 mg/MP 100mg
CEE 0.625mg/dydrogesterone
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menopause Syndrome focused on measuring Menopause Syndrome, low dose estrogen, progestin

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. 40 and 60 years old;
  2. natural amenorrhea for more than 6 months but less than 5 years;
  3. suffered by menopause symptoms and seeking for treatment;
  4. serum follicle-stimulating hormone levels >40 IU/L and serum estradiol <30 pg/ml.

Exclusion Criteria:

  1. contraindications for menopausal hormone therapy;
  2. complications including: uterine myoma more than 3 centimeter in diameter, endometriosis, uncontrolled hypertension or diabetes mellitus, thromboembolic disease history or high risk for developing thromboembolic disease, epilepsy, asthma, hyperprolactinemia, first degree relative has breast cancer;
  3. cardiovascular, chronic liver, thyroid or kidney diseases; a history of cancer; a disease or condition that could influence the participants' ability to follow the study protocol;
  4. alcohol or drug abuse within the last 3 months;
  5. use of hormone therapy in the past 3months;
  6. endometrial thickness more than 5mm even after progestin withdrawal;
  7. abnormal cervical scraping smear;
  8. allergic to any ingredient of the drugs;
  9. participation in other clinical trials within the last 6 months.

Sites / Locations

  • Lei Li

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

CEE 0.625 mg/MP 100mg

CEE 0.3 mg/MP 100mg

CEE 0.625 mg/dydrogesterone 10mg

Arm Description

CEE 0.625 mg/micronized progesterone (MP) 100 mg daily for the last 12 days of every 28 days for two years

CEE 0.3mg/micronized progesterone (MP) 100 mg daily for the last 12 days of every 28 days for two years

CEE 0.625 mg/dydrogesterone 10 mg daily for the last 12 days of every 28 days for two years

Outcomes

Primary Outcome Measures

LDL-cholesterol
body fat mass percentage
DEXA method
breast mammography

Secondary Outcome Measures

glucose
bone mineral density
Mini-mental State Examination score
Questionnaire.The score range is 0-30.Total score greater than or equal to 24 points indicates a normal cognition,below this, scores can indicate cognitive impairment.
HAD scale
questionnaire to evaluate anxiety and depression.The total score is 0-20.Total score 0-7 is normal,8-10 maybe borderline anxiety or depression,11-20 indicates obvious anxiety or depression.
modified Kupperman score
questionnaire to evaluate the menopause symptom.The total score range is 0-63.Total score below 6 is normal,6-15 is mild,16-30 is moderate, above 30 is severe
Endometrial thickness
ultrasound
weight
serum creatinine
serum glutamic pyretic transaminase

Full Information

First Posted
February 2, 2018
Last Updated
February 10, 2018
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03436303
Brief Title
The Benefits and Risks of Different Menopausal Hormone Replacement Therapy Regimes in the Treatment of Menopause Syndrome
Official Title
The Effect and Risk of Conjugated Estrogens Combined With Different Types of Progestin in the Treatment of Menopause Syndrome During Window Phase
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2014 (Actual)
Primary Completion Date
June 1, 2018 (Anticipated)
Study Completion Date
December 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A prospective, open-label, randomized controlled clinical trial to compare the benefits and risks of half-dose or standard-dose conjugated equine estrogens(CEE) plus natural progesterone or dydrogesterone in menopausal hormone therapy .
Detailed Description
This is a prospective, open-label, randomized controlled clinical trial compare the benefits and risks of half-dose or standard-dose conjugated equine estrogens(CEE) plus natural progesterone or dydrogesterone in menopausal hormone therapy during window phase. 120 Healthy postmenopausal women with intact uterus seeking treatment for menopausal symptoms are enrolled in this study.Participants are randomized into three groups, the CEE 0.3 mg/micronized progesterone (MP) 100 mg group; CEE 0.625 mg/MP 100 mg group; CEE 0.625 mg/dydrogesterone 10 mg group,metabolic parameters,body composition,bone mineral density,breast cancer risk factors and life quality will be measure at baseline,one year and two year intervention.The investigators hypothesize there may be differences of these parameters measured among three groups after intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause Syndrome
Keywords
Menopause Syndrome, low dose estrogen, progestin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
randomly assigned to three groups: CEE 0.3 mg/micronized progesterone (MP) 100 mg group, CEE 0.625 mg/MP 100 mg group,CEE 0.625 mg/dydrogesterone 10 mg group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CEE 0.625 mg/MP 100mg
Arm Type
Experimental
Arm Description
CEE 0.625 mg/micronized progesterone (MP) 100 mg daily for the last 12 days of every 28 days for two years
Arm Title
CEE 0.3 mg/MP 100mg
Arm Type
Experimental
Arm Description
CEE 0.3mg/micronized progesterone (MP) 100 mg daily for the last 12 days of every 28 days for two years
Arm Title
CEE 0.625 mg/dydrogesterone 10mg
Arm Type
Experimental
Arm Description
CEE 0.625 mg/dydrogesterone 10 mg daily for the last 12 days of every 28 days for two years
Intervention Type
Drug
Intervention Name(s)
CEE 0.625 mg/MP 100mg
Intervention Description
CEE 0.625 mg daily/MP 100mg daily for the last 12 days of every 28 days for two years
Intervention Type
Drug
Intervention Name(s)
CEE 0.3 mg/MP 100mg
Intervention Description
CEE 0.3 mg daily/MP 100mg daily for the last 12 days of every 28 days for two years
Intervention Type
Drug
Intervention Name(s)
CEE 0.625mg/dydrogesterone
Intervention Description
CEE 0.3 mg/dydrogesterone 10mg daily for the last 12 days of every 28 days for two years
Primary Outcome Measure Information:
Title
LDL-cholesterol
Time Frame
5 minutes
Title
body fat mass percentage
Description
DEXA method
Time Frame
5 minutes
Title
breast mammography
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
glucose
Time Frame
5 minutes
Title
bone mineral density
Time Frame
5 minutes
Title
Mini-mental State Examination score
Description
Questionnaire.The score range is 0-30.Total score greater than or equal to 24 points indicates a normal cognition,below this, scores can indicate cognitive impairment.
Time Frame
5 minutes
Title
HAD scale
Description
questionnaire to evaluate anxiety and depression.The total score is 0-20.Total score 0-7 is normal,8-10 maybe borderline anxiety or depression,11-20 indicates obvious anxiety or depression.
Time Frame
5 minutes
Title
modified Kupperman score
Description
questionnaire to evaluate the menopause symptom.The total score range is 0-63.Total score below 6 is normal,6-15 is mild,16-30 is moderate, above 30 is severe
Time Frame
5 minutes
Title
Endometrial thickness
Description
ultrasound
Time Frame
5 minutes
Title
weight
Time Frame
5 minutes
Title
serum creatinine
Time Frame
5 minutes
Title
serum glutamic pyretic transaminase
Time Frame
5 minutes

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 40 and 60 years old; natural amenorrhea for more than 6 months but less than 5 years; suffered by menopause symptoms and seeking for treatment; serum follicle-stimulating hormone levels >40 IU/L and serum estradiol <30 pg/ml. Exclusion Criteria: contraindications for menopausal hormone therapy; complications including: uterine myoma more than 3 centimeter in diameter, endometriosis, uncontrolled hypertension or diabetes mellitus, thromboembolic disease history or high risk for developing thromboembolic disease, epilepsy, asthma, hyperprolactinemia, first degree relative has breast cancer; cardiovascular, chronic liver, thyroid or kidney diseases; a history of cancer; a disease or condition that could influence the participants' ability to follow the study protocol; alcohol or drug abuse within the last 3 months; use of hormone therapy in the past 3months; endometrial thickness more than 5mm even after progestin withdrawal; abnormal cervical scraping smear; allergic to any ingredient of the drugs; participation in other clinical trials within the last 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aijun Sun, MD
Organizational Affiliation
Peking Union Medical College Hospital,Peking Union Medical College, Chinese Academy of Medicine Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lei Li
City
Beijing
State/Province
China/Beiing
ZIP/Postal Code
100000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Network platform, and the website will be attached later.
IPD Sharing Time Frame
Within 2 months after the trial complete
IPD Sharing Access Criteria
Data access requests will be reviewed by an external independent review panel.Requestors will be required to sign a Data Access Agreement.
Citations:
PubMed Identifier
17689624
Citation
Thorneycroft IH, Lindsay R, Pickar JH. Body composition during treatment with conjugated estrogens with and without medroxyprogesterone acetate: analysis of the women's Health, Osteoporosis, Progestin, Estrogen (HOPE) trial. Am J Obstet Gynecol. 2007 Aug;197(2):137.e1-7. doi: 10.1016/j.ajog.2007.05.042.
Results Reference
background
PubMed Identifier
15252707
Citation
Margolis KL, Bonds DE, Rodabough RJ, Tinker L, Phillips LS, Allen C, Bassford T, Burke G, Torrens J, Howard BV; Women's Health Initiative Investigators. Effect of oestrogen plus progestin on the incidence of diabetes in postmenopausal women: results from the Women's Health Initiative Hormone Trial. Diabetologia. 2004 Jul;47(7):1175-1187. doi: 10.1007/s00125-004-1448-x. Epub 2004 Jul 14.
Results Reference
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The Benefits and Risks of Different Menopausal Hormone Replacement Therapy Regimes in the Treatment of Menopause Syndrome

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