The Effect of Different Types of Progestin on Sleeping of Menopausal Women
NCT ID: NCT02086032
Last Updated: 2017-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2014-01-31
2015-07-31
Brief Summary
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There have been papers reporting the effect of hormonal therapy on sleeping, but fews have reported the effect of different progestogens on sleeping quality. There is a need for more in-depth study and more conclusive evidence about the progestins which have the most beneficial effects on sleeping disorders in menopausal women.
This study is going to collect the data from newly identified menopausal patients who are eligible for continuous estrogen-progestogen therapy for their climacteric treatment. The affects of the therapy will be monitored for 3 months.
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Detailed Description
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They will be allocated randomly into 2 different groups, each group being prescribed 1 of 2 regimens of hormonal therapy:
* 17 beta estradiol 1mg/day plus oral micronized progesterone 100mg/day
* 17 beta estradiol 1mg/day plus dydrogesterone 10mg/day Patients will have their sleeping quality accessed using the Pittsburgh sleep quality index(PSQI) at their 1st visit and once a month for 3 months. The first and third PSQI score will be analysed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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micronized progesterone
1 mg 17 beta-estradiol plus 100 mg micronized progesterone taken orally once a day for 3 months.
1mg 17 beta-estradiol
Comparing sleeping quality between micronized progesterone and dydrogesterone users.
micronized progesterone
Comparing sleeping quality between micronised progesterone and dydrogesterone users
dydrogesterone
1mg 17 beta-estradiol plus 10 mg dydrogesterone taken orally once a day for 3 months.
1mg 17 beta-estradiol
Comparing sleeping quality between micronized progesterone and dydrogesterone users.
Dydrogesterone
Comparing sleeping quality between micronised progesterone and dydrogesterone users.
Interventions
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1mg 17 beta-estradiol
Comparing sleeping quality between micronized progesterone and dydrogesterone users.
Dydrogesterone
Comparing sleeping quality between micronised progesterone and dydrogesterone users.
micronized progesterone
Comparing sleeping quality between micronised progesterone and dydrogesterone users
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* suitable for estrogen plus progesterone treatment
Exclusion Criteria
* recently used sleep enhancing medicine
* recently used psychotic medicine
40 Years
65 Years
FEMALE
Yes
Sponsors
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Chiang Mai University
OTHER
Responsible Party
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Ekachai Leeangkoonsathian
MD
Principal Investigators
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Tawiwan Pantasri, MD
Role: PRINCIPAL_INVESTIGATOR
Faculty of Medicine, Chiang Mai University, Thailand
Locations
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Obstetrics and Gynecology department, Faculty of Medicine, Chiang Mai University
Muang, Chiang Mai, Thailand
Countries
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References
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Leeangkoonsathian E, Pantasri T, Chaovisitseree S, Morakot N. The effect of different progestogens on sleep in postmenopausal women: a randomized trial. Gynecol Endocrinol. 2017 Dec;33(12):933-936. doi: 10.1080/09513590.2017.1333094. Epub 2017 Jun 13.
Other Identifiers
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OBG-2556-02070
Identifier Type: -
Identifier Source: org_study_id
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