Effect of Estrogen Therapy on Objective Sleep Quality in Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pimpika Tansupswatdikul, MD., Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01501422
First received: November 14, 2011
Last updated: December 26, 2012
Last verified: December 2012
  Purpose
  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.

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:


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:
  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.
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

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 July 28, 2014