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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
Estrogen also regulate gamma-aminobutyric acid (GABA) secretion
According to epidemiologic data, problem of sleep was increasing in postmenopause group compare to premenopause group (aged-match)
This research perform to find out the actual effect of estrogen in improving sleep quality.
40-60 year-old postmenopausal women with insomnia and mild-moderate vasomotor symptom were screened and included in project
Block of four randomization was use to categorize participants into 2 groups
Sleep quality was measured before intervention by subjective and objective sleep quality
wrist actigraph sleep test at home for 1 week
Intervention phase : continuous use of weekly patch for 8 weeks
Follow up phase
Then the data will be analysed and open label, in nonhysterectomized postmenopausal women in study group will take the medroxyprogesterone acetate for washing out the endometrium for 2 weeks
The participants will be counseled, further investigate and proper treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Estrogen | Experimental | Use estrogen patch for 8 weeks |
|
| Placebo | Experimental | Use placebo patch for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estrogen patch | Drug | 50 microgram estrogen patch weekly |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep latency (SL) | Sleep latency is the time period measured from "lights out," or bedtime, to the beginning of sleep. | 8 months |
| Total sleep time (TST) | TST is amount of actual sleep time in a sleep period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pimpika Tansupswatdikul, MD. | Chulalongkorn University | Principal Investigator |
| Sukanya Chaikiitisilpa, MD. | Chulalongkorn University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Menopause Clinic, Menopause research unit, King Chulalongkorn Memorial Hospital | Pathumwan | Bangkok | 10330 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18568788 | Background | Kalleinen N, Polo O, Himanen SL, Joutsen A, Polo-Kantola P. The effect of estrogen plus progestin treatment on sleep: a randomized, placebo-controlled, double-blind trial in premenopausal and late postmenopausal women. Climacteric. 2008 Jun;11(3):233-43. doi: 10.1080/13697130802112033. | |
| 20443720 | Background |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Drug |
Placebo patch for 8 weeks |
|
| 8 months |
| Wake time after sleep onset (WASO) | WASO is the total time of awake occurring between sleep onset and final wake up. | 8 months |
| Number of awakening | Number of awakening is the number of awakening during onset of sleep and final wake-up. | 8 months |
| Score of two sleep quality assessment questionnaires. |
| 8 months |
| Huang KE, Baber R; Asia Pacific Tibolone Consensus Group. Updated clinical recommendations for the use of tibolone in Asian women. Climacteric. 2010 Aug;13(4):317-27. doi: 10.3109/13697131003681458. |
| 11602005 | Background | Halbreich U, Kahn LS. Role of estrogen in the aetiology and treatment of mood disorders. CNS Drugs. 2001;15(10):797-817. doi: 10.2165/00023210-200115100-00005. |
| 12440557 | Background | Shanafelt TD, Barton DL, Adjei AA, Loprinzi CL. Pathophysiology and treatment of hot flashes. Mayo Clin Proc. 2002 Nov;77(11):1207-18. doi: 10.4065/77.11.1207. |
| 16145308 | Background | Sarti CD, Chiantera A, Graziottin A, Ognisanti F, Sidoli C, Mincigrucci M, Parazzini F; Gruppo di Studio IperAOGOI. Hormone therapy and sleep quality in women around menopause. Menopause. 2005 Sep-Oct;12(5):545-51. doi: 10.1097/01.gme.0000172270.70690.5e. Epub 2005 Sep 1. |
| 1508062 | Background | Wiklund I, Berg G, Hammar M, Karlberg J, Lindgren R, Sandin K. Long-term effect of transdermal hormonal therapy on aspects of quality of life in postmenopausal women. Maturitas. 1992 Mar;14(3):225-36. doi: 10.1016/0378-5122(92)90117-m. |
| 9609575 | Background | Polo-Kantola P, Erkkola R, Helenius H, Irjala K, Polo O. When does estrogen replacement therapy improve sleep quality? Am J Obstet Gynecol. 1998 May;178(5):1002-9. doi: 10.1016/s0002-9378(98)70539-3. |
| 14669843 | Background | Saletu B. Sleep, vigilance and cognition in postmenopausal women: placebo-controlled studies with 2 mg estradiol valerate, with and without 3 mg dienogest. Climacteric. 2003 Aug;6 Suppl 2:37-45. |
| 19002015 | Background | Ensrud KE, Stone KL, Blackwell TL, Sawaya GF, Tagliaferri M, Diem SJ, Grady D. Frequency and severity of hot flashes and sleep disturbance in postmenopausal women with hot flashes. Menopause. 2009 Mar-Apr;16(2):286-92. doi: 10.1097/gme.0b013e31818c0485. |
| 20441593 | Background | Tranah GJ, Parimi N, Blackwell T, Ancoli-Israel S, Ensrud KE, Cauley JA, Redline S, Lane N, Paudel ML, Hillier TA, Yaffe K, Cummings SR, Stone KL. Postmenopausal hormones and sleep quality in the elderly: a population based study. BMC Womens Health. 2010 May 4;10:15. doi: 10.1186/1472-6874-10-15. |
| 25242569 | Derived | Tansupswatdikul P, Chaikittisilpa S, Jaimchariyatam N, Panyakhamlerd K, Jaisamrarn U, Taechakraichana N. Effects of estrogen therapy on postmenopausal sleep quality regardless of vasomotor symptoms: a randomized trial. Climacteric. 2015 Apr;18(2):198-204. doi: 10.3109/13697137.2014.964670. Epub 2014 Nov 27. |
| D001523 |
| Mental Disorders |