Clinical trial NCT01501422: Effect of Estrogen Therapy on Objective Sleep Quality in Postmenopausal Women
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Insomniac Postmenopausal Women
Keywords: postmenopause
sleep quality
estrogen
objective sleep quality
actigraph
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2011-12-29
Enrollment: 40
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Sleep efficiency (SE)
timeFrame: 8 months
Secondary outcomes:
measure: Sleep latency (SL)
timeFrame: 8 months
measure: Total sleep time (TST)
timeFrame: 8 months
measure: Wake time after sleep onset (WASO)
timeFrame: 8 months
measure: Number of awakening
timeFrame: 8 months
measure: Score of two sleep quality assessment questionnaires.
timeFrame: 8 months
Other outcomes:
Locations:
city: Pathumwan
country: Thailand
facility: Menopause Clinic, Menopause research unit, King Chulalongkorn Memorial Hospital
state: Bangkok
Study officials:
affiliation: Chulalongkorn University
name: Pimpika Tansupswatdikul, MD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chulalongkorn University
name: Sukanya Chaikiitisilpa, MD.
role: STUDY_CHAIR
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citation: 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.