CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 40 enrolled
Drug / intervention
Estrogen patch +1 moredrug
Likely dose
Estrogen patch 50 microgramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01501422
NCT01501422Phase 3Completed
CompareCT.gov

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

Chulalongkorn University·interventional·Posted Dec 29, 2011·Updated Dec 28, 2012

In Brief

A Phase 3 clinical trial evaluating Estrogen patch and Placebo for Insomniac Postmenopausal Women. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomniac Postmenopausal Women
CountriesThailand
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 29, 2011
Enrollment StartJul 1, 2011
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 14.5 years ago

Interventions

Estrogen patchdrug

50 microgram estrogen patch weekly

Placebodrug

Placebo patch for 8 weeks