Effect of Estrogen Therapy on Objective Sleep Quality in Postmenopausal Women - Full Text View

Purpose

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
- GABA substance is in order to initiate sleep and continue sleep
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.

Condition	Intervention	Phase
Insomniac Postmenopausal Women	Drug: Estrogen patch Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Menopause

U.S. FDA Resources

Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:

Sleep efficiency (SE) [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
Sleep efficiency is proportion of sleep in the period potentially filled by sleep-ratio of total sleep time to time in bed.

Secondary Outcome Measures:

Sleep latency (SL) [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
Sleep latency is the time period measured from "lights out," or bedtime, to the beginning of sleep.
Total sleep time (TST) [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
TST is amount of actual sleep time in a sleep period.
Wake time after sleep onset (WASO) [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
WASO is the total time of awake occurring between sleep onset and final wake up.
Number of awakening [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
Number of awakening is the number of awakening during onset of sleep and final wake-up.
Score of two sleep quality assessment questionnaires. [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
- 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.

Enrollment:	40
Study Start Date:	July 2011
Study Completion Date:	January 2012
Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Estrogen Use estrogen patch for 8 weeks	Drug: Estrogen patch 50 microgram estrogen patch weekly
Experimental: Placebo Use placebo patch for 8 weeks	Drug: Placebo Placebo patch for 8 weeks

Detailed Description:

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
- Study group (estrogen patch)
- Control group (placebo patch)
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
Intervention phase : continuous use of weekly patch for 8 weeks
- Estrogen patch in study group
- Placebo patch in control group
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
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.

Eligibility

Ages Eligible for Study:	40 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01501422

Locations

Thailand
Menopause Clinic, Menopause research unit, King Chulalongkorn Memorial Hospital
Pathumwan, Bangkok, Thailand, 10330

Sponsors and Collaborators

Chulalongkorn University

Investigators

Principal Investigator:	Pimpika Tansupswatdikul, MD.	Chulalongkorn University
Study Chair:	Sukanya Chaikiitisilpa, MD.	Chulalongkorn University

More Information

Publications:

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.

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. Review.

Halbreich U, Kahn LS. Role of estrogen in the aetiology and treatment of mood disorders. CNS Drugs. 2001;15(10):797-817. Review.

Shanafelt TD, Barton DL, Adjei AA, Loprinzi CL. Pathophysiology and treatment of hot flashes. Mayo Clin Proc. 2002 Nov;77(11):1207-18. Review. Erratum in: Mayo Clin Proc. 2004 Aug;79(8):1088.

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. 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.

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.

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.

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.

Responsible Party:	Pimpika Tansupswatdikul, MD., Principle investigator, Chulalongkorn University
ClinicalTrials.gov Identifier:	NCT01501422 History of Changes
Other Study ID Numbers:	MRU CU-1/2011
Study First Received:	November 14, 2011
Last Updated:	December 26, 2012
Health Authority:	Thailand: Food and Drug Administration

Keywords provided by Chulalongkorn University:

postmenopause
sleep quality
estrogen
objective sleep quality
actigraph

Additional relevant MeSH terms:

Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013