NCT02086032

The Effect of Different Types of Progestin on Sleeping of Menopausal Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Chiang Mai University · Academic / Other
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Menopausal and Postmenopausal Disorders

Interventions

Type	Name	Description
DRUG	1mg 17 beta-estradiol	Comparing sleeping quality between micronized progesterone and dydrogesterone users.
DRUG	Dydrogesterone	Comparing sleeping quality between micronised progesterone and dydrogesterone users.
DRUG	micronized progesterone	Comparing sleeping quality between micronised progesterone and dydrogesterone users

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-06-01
• Completion: 2015-07-01
• First posted: 2014-03-13
• Last updated: 2017-05-31

Locations

1 site across 1 country: Thailand