NCT01501422|CompletedPhase 3
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Sponsor study identifier
interventional
40
1 country
1
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2012
Actual (reported)Study Completion
January 2012
Actual (reported)Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
November 14, 2011
Actual (reported)December 29, 2011
Actual (reported)January 2012
Actual (reported)January 2012
Actual (reported)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
Sleep latency (SL)
8 months
Total sleep time (TST)
8 months
Wake time after sleep onset (WASO)
8 months
Number of awakening
8 months
Score of two sleep quality assessment questionnaires.
8 months
Use estrogen patch for 8 weeks
Use placebo patch for 8 weeks
50 microgram estrogen patch weekly
Placebo patch for 8 weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Menopause Clinic, Menopause research unit, King Chulalongkorn Memorial Hospital
Pathumwan, Bangkok, 10330, Thailand
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.
Pimpika Tansupswatdikul, MD.
Chulalongkorn University
Sukanya Chaikiitisilpa, MD.
Chulalongkorn University
40 participants (actual enrollment reported by the registry).
First Submitted
November 14, 2011
First Posted
December 29, 2011
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
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.
Primary Completion
January 2012
Actual (reported)Study Completion
January 2012
Actual (reported)Last Updated
December 28, 2012
Record last verified: 2012-12
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Source: ClinicalTrials.gov.
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