NCT01501422

Effect of Estrogen Therapy on Objective Sleep Quality in Postmenopausal Women

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: Female
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Insomniac Postmenopausal Women

Interventions

Type	Name	Description
DRUG	Estrogen patch	50 microgram estrogen patch weekly
DRUG	Placebo	Placebo patch for 8 weeks

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2011-12-29
• Last updated: 2012-12-28

Locations

1 site across 1 country: Thailand