Effect of Estrogen Therapy on Objective Sleep Quality in Postmenopausal Women

Chulalongkorn University

Status and phase: Completed; Phase 3

Conditions: Insomniac Postmenopausal Women

Treatments: Drug: Placebo; Drug: Estrogen patch

Study type: Interventional

Funder types: Other

Identifiers

NCT01501422

MRU CU-1/2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Estrogen

Experimental group

Description:

Use estrogen patch for 8 weeks

Treatment:

Drug: Estrogen patch

Placebo

Experimental group

Description:

Use placebo patch for 8 weeks

Treatment:

Drug: Placebo