Status:
COMPLETED
Effect of Estrogen Therapy on Objective Sleep Quality in Postmenopausal Women
Lead Sponsor:
Chulalongkorn University
Conditions:
Insomniac Postmenopausal Women
Eligibility:
FEMALE
40-60 years
Phase:
PHASE3
Brief Summary
1. Sex hormone including estrogen have synergistic effect to serotonin activity and decrease activity of monoamine oxidase activity so the norepinephrine is not be metabolized, these substance are imp...
Detailed Description
1. 40-60 year-old postmenopausal women with insomnia and mild-moderate vasomotor symptom were screened and included in project 2. Block of four randomization was use to categorize participants into 2 ...
Eligibility Criteria
Inclusion
- Postmenopausal women 40-60 years old
- Mild to moderate vasomotor symptom
- Insomnia
- fluent read and write in Thai language
- Inform consent
Exclusion
- Acute liver and gall bladder disease
- undiagnosed abnormal bleeding per vagina
- History of BIRADs 3 from mammogram
- History or current venous thrombosis, embolism
- diagnosis of sleep disorder
- use of hypnotic drug or antihistamine in the past month
- Diagnosis of psychiatric disorder such as depressive disorder, schizophrenia, anxiety disorder
- No past history of malignancy
- No history of chronic renal disease, alzheimer's disease, uncontrolled hypertension, uncontrolled diabetes mellitus
- history of estrogen use in past 6 months
- drug abuse, Alcohol
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01501422
Start Date
July 1 2011
End Date
January 1 2012
Last Update
December 28 2012
Active Locations (1)
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1
Menopause Clinic, Menopause research unit, King Chulalongkorn Memorial Hospital
Pathumwan, Bangkok, Thailand, 10330