Effect of Estrogen Therapy on Objective Sleep Quality in Postmenopausal Women

December 26, 2012 updated by: Pimpika Tansupswatdikul, MD., Chulalongkorn University

Effect of Estrogen Therapy on Objective Sleep Quality in Postmenopausal Women at Menopause Clinic, King Chulalongkorn Memorial Hospital, Double- Blind, Randomized, Placebo-controlled Trial

  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. 40-60 year-old postmenopausal women with insomnia and mild-moderate vasomotor symptom were screened and included in project

  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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep latency (SL)
Time Frame: 8 months
Sleep latency is the time period measured from "lights out," or bedtime, to the beginning of sleep.
8 months
Total sleep time (TST)
Time Frame: 8 months
TST is amount of actual sleep time in a sleep period.
8 months
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.
8 months
Number of awakening
Time Frame: 8 months
Number of awakening is the number of awakening during onset of sleep and final wake-up.
8 months
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.
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

November 14, 2011

First Submitted That Met QC Criteria

December 24, 2011

First Posted (Estimate)

December 29, 2011

Study Record Updates

Last Update Posted (Estimate)

December 28, 2012

Last Update Submitted That Met QC Criteria

December 26, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRU CU-1/2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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