Effect of Estrogen Therapy on Objective Sleep Quality in Postmenopausal Women

Phase 3

Completed

• Conditions: Insomniac Postmenopausal Women
• Interventions: Drug: Estrogen patch; Drug: Placebo

• Registration Number: NCT01501422
• Lead Sponsor: Chulalongkorn University

Brief Summary

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.

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 Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-11-14
• Study First Submitted QC: 2011-12-24
• Study First Posted: 2011-12-29
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-26
• Last Update Posted: 2012-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Estrogen	Estrogen patch	Use estrogen patch for 8 weeks
Placebo	Placebo	Use placebo patch for 8 weeks

Primary Outcome Measures

Name	Time	Method
Sleep efficiency (SE)	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 Outcome Measures

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

Trial Locations

Locations (1)

Menopause Clinic, Menopause research unit, King Chulalongkorn Memorial Hospital; 🇹🇭 Pathumwan, Bangkok, Thailand