Effect of Estrogen Therapy on Objective Sleep Quality in Postmenopausal Women

NCT01501422 | Completed Phase 3

• 1 other identifier: MRU CU-1/2011
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.Estrogen also regulate gamma-aminobutyric acid (GABA) secretion
3. 3.GABA substance is in order to initiate sleep and continue sleep
4. 4.According to epidemiologic data, problem of sleep was increasing in postmenopause group compare to premenopause group (aged-match)
5. 5.This research perform to find out the actual effect of estrogen in improving sleep quality.

Conditions

Insomniac Postmenopausal Women

Keywords

postmenopause; sleep quality; estrogen; objective sleep quality; actigraph

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

Study Arms (2)

Estrogen

EXPERIMENTAL

Use estrogen patch for 8 weeks

Drug: Estrogen patch

Placebo

EXPERIMENTAL

Use placebo patch for 8 weeks

Drug: Placebo

Interventions

Estrogen patch DRUG

50 microgram estrogen patch weekly

Estrogen

Placebo DRUG

Placebo patch for 8 weeks

Placebo

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Postmenopausal women 40-60 years old
• Mild to moderate vasomotor symptom
• Insomnia
• fluent read and write in Thai language
• Inform consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Menopause Clinic, Menopause research unit, King Chulalongkorn Memorial Hospital

Pathumwan, Bangkok, 10330, Thailand

Location

Related Publications (11)

• 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.

  PMID: 18568788 BACKGROUND

• 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.

  PMID: 20443720 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.

  PMID: 11602005 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.

  PMID: 12440557 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.

  PMID: 16145308 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.

  PMID: 1508062 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.

  PMID: 9609575 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.

  PMID: 14669843 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.

  PMID: 19002015 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.

  PMID: 20441593 BACKGROUND

• 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.

  PMID: 25242569 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Pimpika Tansupswatdikul, MD.

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

• Sukanya Chaikiitisilpa, MD.

  Chulalongkorn University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: November 14, 2011
• First Posted: December 29, 2011
• Study Start: July 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: December 28, 2012

Record last verified: 2012-12

Locations

TH (1)