Insomniac Postmenopausal Women Clinical Trial
Official title:
Effect of Estrogen Therapy on Objective Sleep Quality in Postmenopausal Women at Menopause Clinic, King Chulalongkorn Memorial Hospital, Double- Blind, Randomized, Placebo-controlled Trial
| Verified date | December 2012 |
| Source | Chulalongkorn University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Thailand: Food and Drug Administration |
| Study type | Interventional |
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 important to regulate hemostasis and circadian process
of sleep
2. Estrogen also regulate gamma-aminobutyric acid (GABA) secretion
- GABA substance is in order to initiate sleep and continue sleep
3. According to epidemiologic data, problem of sleep was increasing in postmenopause group
compare to premenopause group (aged-match)
4. This research perform to find out the actual effect of estrogen in improving sleep
quality.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | January 2012 |
| Est. primary completion date | January 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 40 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - Postmenopausal women 40-60 years old - Mild to moderate vasomotor symptom - Insomnia - fluent read and write in Thai language - Inform consent Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Menopause Clinic, Menopause research unit, King Chulalongkorn Memorial Hospital | Pathumwan | Bangkok |
| Lead Sponsor | Collaborator |
|---|---|
| Chulalongkorn University |
Thailand,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Sleep efficiency (SE) | Sleep efficiency is proportion of sleep in the period potentially filled by sleep-ratio of total sleep time to time in bed. | 8 months | Yes |
| Secondary | Sleep latency (SL) | Sleep latency is the time period measured from "lights out," or bedtime, to the beginning of sleep. | 8 months | Yes |
| Secondary | Total sleep time (TST) | TST is amount of actual sleep time in a sleep period. | 8 months | Yes |
| Secondary | Wake time after sleep onset (WASO) | WASO is the total time of awake occurring between sleep onset and final wake up. | 8 months | Yes |
| Secondary | Number of awakening | Number of awakening is the number of awakening during onset of sleep and final wake-up. | 8 months | Yes |
| Secondary | Score of two sleep quality assessment questionnaires. | Insomnia severity index is the 7 topic questionnaire for determine the severity of insomnia problem. Ebworth severity index is the questionnaire to assess daytime sleepiness. |
8 months | Yes |