Status:
UNKNOWN
the Effects of Different Therapy Regimens on Menopausal Sleep Disorders
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Menopause
Sleep Disorder
Eligibility:
FEMALE
40-60 years
Phase:
PHASE4
Brief Summary
Sleeping disorders are one of the most common menopausal symptoms, which seriously affect health and life quality of perimenopausal women. Menopausal hormone therapy is an effective treatment for meno...
Eligibility Criteria
Inclusion
- women aged 40-60
- natural menopause for 1-10 years
- PSQI score \>=11 points
- improved K-score\>=14 points
- able to independently sign informed consent forms
Exclusion
- Vaginal bleeding of unknown cause
- Known or suspected breast cancer and other sex hormone dependent tumors
- Active venous or arterial thromboembolic disease within past 6 months
- Have used sex hormone or traditional Chinese medicine/botanical drugs that affect menopausal symptoms within the past month
- Have used anti anxiety, depression drugs or sedative hypnotics within the past month
- Patients with anxiety or depression above moderate level
- Severe liver or kidney dysfunction, with transaminase or creatinine level exceeding twice of the normal value
- BMI ≥ 28 kg/m2
- Allergies to research drugs
- Other situations that doctor deems unsuitable to participate in the study
Key Trial Info
Start Date :
December 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06117969
Start Date
December 30 2023
End Date
September 30 2025
Last Update
January 2 2024
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