Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-02-27 @ 11:19 AM
Study NCT ID:
NCT02086032
Status:
COMPLETED
Last Update Posted:
2017-05-31
First Post:
2014-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Different Types of Progestin on Sleeping of Menopausal Women
Sponsor:
Chiang Mai University
Organization:
Study Overview
Official Title:
The Effect of Different Types of Progestin on Sleeping of Menopausal Women
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
New patients who are eligible for hormonal therapy will be selected.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: