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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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ClinicalTrials.gov Identifier: NCT03436303
Recruitment Status : Active, not recruiting
First Posted : February 16, 2018
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
Aijun Sun, Peking Union Medical College Hospital

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 .

Condition or disease Intervention/treatment Phase
Menopause Syndrome Drug: CEE 0.625 mg/MP 100mg Drug: CEE 0.3 mg/MP 100mg Drug: CEE 0.625mg/dydrogesterone Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: The Effect and Risk of Conjugated Estrogens Combined With Different Types of Progestin in the Treatment of Menopause Syndrome During Window Phase
Actual Study Start Date : February 1, 2014
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CEE 0.625 mg/MP 100mg
CEE 0.625 mg/micronized progesterone (MP) 100 mg daily for the last 12 days of every 28 days for two years
Drug: CEE 0.625 mg/MP 100mg
CEE 0.625 mg daily/MP 100mg daily for the last 12 days of every 28 days for two years

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

Experimental: CEE 0.625 mg/dydrogesterone 10mg
CEE 0.625 mg/dydrogesterone 10 mg daily for the last 12 days of every 28 days for two years
Drug: CEE 0.625mg/dydrogesterone
CEE 0.3 mg/dydrogesterone 10mg daily for the last 12 days of every 28 days for two years




Primary Outcome Measures :
  1. LDL-cholesterol [ Time Frame: 5 minutes ]
  2. body fat mass percentage [ Time Frame: 5 minutes ]
    DEXA method

  3. breast mammography [ Time Frame: 5 minutes ]

Secondary Outcome Measures :
  1. glucose [ Time Frame: 5 minutes ]
  2. bone mineral density [ Time Frame: 5 minutes ]
  3. Mini-mental State Examination score [ Time Frame: 5 minutes ]
    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.

  4. HAD scale [ Time Frame: 5 minutes ]
    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.

  5. modified Kupperman score [ Time Frame: 5 minutes ]
    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

  6. Endometrial thickness [ Time Frame: 5 minutes ]
    ultrasound

  7. weight [ Time Frame: 5 minutes ]
  8. serum creatinine [ Time Frame: 5 minutes ]
  9. serum glutamic pyretic transaminase [ Time Frame: 5 minutes ]


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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03436303


Locations
China, China/Beiing
Lei Li
Beijing, China/Beiing, China, 100000
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Principal Investigator: Aijun Sun, MD Peking Union Medical College Hospital,Peking Union Medical College, Chinese Academy of Medicine Sciences

Publications:
Responsible Party: Aijun Sun, professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03436303     History of Changes
Other Study ID Numbers: HRT14021808
First Posted: February 16, 2018    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Network platform, and the website will be attached later.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Within 2 months after the trial complete
Access Criteria: Data access requests will be reviewed by an external independent review panel.Requestors will be required to sign a Data Access Agreement.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aijun Sun, Peking Union Medical College Hospital:
Menopause Syndrome
low dose estrogen
progestin

Additional relevant MeSH terms:
Syndrome
Disease
Pathologic Processes
Estrogens
Progestins
Dydrogesterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs