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Effect of Estrogen Therapy on Objective Sleep Quality in Postmenopausal Women

NCT01501422 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-12-28

No results posted yet for this study

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.

Conditions

  • Insomniac Postmenopausal Women

Interventions

DRUG

Estrogen patch

50 microgram estrogen patch weekly

DRUG

Placebo

Placebo patch for 8 weeks

Sponsors & Collaborators

  • Chulalongkorn University

    lead OTHER

Principal Investigators

  • Pimpika Tansupswatdikul, MD. · Chulalongkorn University

  • Sukanya Chaikiitisilpa, MD. · Chulalongkorn University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • Thailand

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01501422 on ClinicalTrials.gov