Effect of Estrogen Therapy on Objective Sleep Quality in Postmenopausal Women
NCT ID: NCT01501422
Last Updated: 2012-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
40 participants
INTERVENTIONAL
2011-07-31
2012-01-31
Brief Summary
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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.
Detailed Description
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2. Block of four randomization was use to categorize participants into 2 groups
* Study group (estrogen patch)
* Control group (placebo patch)
3. Sleep quality was measured before intervention by subjective and objective sleep quality
* Subjective sleep quality (self sleep questionnaire)
* Objective sleep quality (wrist actigraphy and sleep diary):
wrist actigraph sleep test at home for 1 week
4. Intervention phase : continuous use of weekly patch for 8 weeks
* Estrogen patch in study group
* Placebo patch in control group
5. Follow up phase
* At 4 weeks of use, investigator will telephone call for follow up the participant's compliance and the side effects during patch use.
* After completed use of 7th patch, sleep quality was measured again, self sleep quality questionnaire and 1 week-wrist actigraphy and sleep diary test
6. 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
7. The participants will be counseled, further investigate and proper treatment.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Estrogen
Use estrogen patch for 8 weeks
Estrogen patch
50 microgram estrogen patch weekly
Placebo
Use placebo patch for 8 weeks
Placebo
Placebo patch for 8 weeks
Interventions
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Estrogen patch
50 microgram estrogen patch weekly
Placebo
Placebo patch for 8 weeks
Eligibility Criteria
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Inclusion Criteria
* Mild to moderate vasomotor symptom
* Insomnia
* fluent read and write in Thai language
* Inform consent
Exclusion Criteria
* 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
40 Years
60 Years
FEMALE
Yes
Sponsors
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Chulalongkorn University
OTHER
Responsible Party
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Pimpika Tansupswatdikul, MD.
Principle investigator
Principal Investigators
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Pimpika Tansupswatdikul, MD.
Role: PRINCIPAL_INVESTIGATOR
Chulalongkorn University
Sukanya Chaikiitisilpa, MD.
Role: STUDY_CHAIR
Chulalongkorn University
Locations
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Menopause Clinic, Menopause research unit, King Chulalongkorn Memorial Hospital
Pathumwan, Bangkok, Thailand
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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MRU CU-1/2011
Identifier Type: -
Identifier Source: org_study_id