Status:
UNKNOWN
The Benefits and Risks of Different Menopausal Hormone Replacement Therapy Regimes in the Treatment of Menopause Syndrome
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Menopause Syndrome
Eligibility:
FEMALE
40-60 years
Phase:
PHASE4
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 dydrogeste...
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 dydro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03436303
Start Date
February 1 2014
End Date
December 1 2018
Last Update
February 19 2018
Active Locations (1)
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1
Lei Li
Beijing, China/Beiing, China, 100000