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Completed

NCT Number: NCT01501422

Effect of Estrogen Therapy on Objective Sleep Quality in Postmenopausal Women

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. 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.

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Key information

Conditions

Insomniac Postmenopausal Women Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Menopause Clinic, Menopause research unit, King Chulalongkorn Memorial Hospital

Pathumwan, Bangkok, 10330, Thailand

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Estrogen patch

Drug

50 microgram estrogen patch weekly

Placebo

Drug

Placebo patch for 8 weeks

Primary outcomes

  1. Sleep efficiency (SE)

    Time frame: 8 months

    Sleep efficiency is proportion of sleep in the period potentially filled by sleep-ratio of total sleep time to time in bed.

Secondary outcomes

  1. Sleep latency (SL)

    Time frame: 8 months

    Sleep latency is the time period measured from "lights out," or bedtime, to the beginning of sleep.

  2. Total sleep time (TST)

    Time frame: 8 months

    TST is amount of actual sleep time in a sleep period.

  3. Wake time after sleep onset (WASO)

    Time frame: 8 months

    WASO is the total time of awake occurring between sleep onset and final wake up.

  4. Number of awakening

    Time frame: 8 months

    Number of awakening is the number of awakening during onset of sleep and final wake-up.

  5. Score of two sleep quality assessment questionnaires.

    Time frame: 8 months

    • 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.

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 29, 2011
Registry last updated
Dec 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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