The Effect of Different Types of Progestin on Sleeping of Menopausal Women
1 other identifier
interventional
100
1 country
1
Brief Summary
Investigators have found that sleeping disorder is an important problem in menopausal women. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 1, 2014
CompletedFirst Posted
Study publicly available on registry
March 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedMay 31, 2017
May 1, 2017
1.4 years
March 1, 2014
May 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improving of sleeping quality (assessed by the PSQI score)
from March 2014 up to 15 months
Secondary Outcomes (2)
The side effects comparing the 2 arms.
from March 2014 up to 15 months
The climacteric symptoms comparing the 2 arms.
from March 2014 up to 15 months
Study Arms (2)
micronized progesterone
EXPERIMENTAL1 mg 17 beta-estradiol plus 100 mg micronized progesterone taken orally once a day for 3 months.
dydrogesterone
EXPERIMENTAL1mg 17 beta-estradiol plus 10 mg dydrogesterone taken orally once a day for 3 months.
Interventions
Comparing sleeping quality between micronized progesterone and dydrogesterone users.
Comparing sleeping quality between micronised progesterone and dydrogesterone users.
Comparing sleeping quality between micronised progesterone and dydrogesterone users
Eligibility Criteria
You may qualify if:
- new menopausal patients at Maharaj Nakorn Chiang Mai Hospital
- suitable for estrogen plus progesterone treatment
You may not qualify if:
- contraindication for hormone replacement therapy
- recently used sleep enhancing medicine
- recently used psychotic medicine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Obstetrics and Gynecology department, Faculty of Medicine, Chiang Mai University
Muang, Chiang Mai, 50200, Thailand
Related Publications (1)
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.
PMID: 28609128DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tawiwan Pantasri, MD
Faculty of Medicine, Chiang Mai University, Thailand
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 1, 2014
First Posted
March 13, 2014
Study Start
January 1, 2014
Primary Completion
June 1, 2015
Study Completion
July 1, 2015
Last Updated
May 31, 2017
Record last verified: 2017-05