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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Menopausal and Postmenopausal Disorders

Intervention / Treatment
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* Drug: 1mg 17 beta-estradiol
* Drug: Dydrogesterone
* Drug: micronized progesterone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: new menopausal patients at Maharaj Nakorn Chiang Mai Hospital suitable for estrogen plus progesterone treatment Exclusion Criteria: contraindication for hormone replacement therapy recently used sleep enhancing medicine recently used psychotic medicine

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: micronized progesterone<br>1 mg 17 beta-estradiol plus 100 mg micronized progesterone taken orally once a day for 3 months. | Drug: 1mg 17 beta-estradiol<br>* Comparing sleeping quality between micronized progesterone and dydrogesterone users.<br>* Other names: Estrogen;Drug: micronized progesterone<br>* Comparing sleeping quality between micronised progesterone and dydrogesterone users<br>* Other names: Utrogestan;|
| Experimental: dydrogesterone<br>1mg 17 beta-estradiol plus 10 mg dydrogesterone taken orally once a day for 3 months. | Drug: 1mg 17 beta-estradiol<br>* Comparing sleeping quality between micronized progesterone and dydrogesterone users.<br>* Other names: Estrogen;Drug: Dydrogesterone<br>* Comparing sleeping quality between micronised progesterone and dydrogesterone users.<br>* Other names: Duphaston;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improving of sleeping quality (assessed by the PSQI score) |  | from March 2014 up to 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The side effects comparing the 2 arms. | Acne,melanoma, breast tenderness, abnormal vaginal bleeding, weight change | from March 2014 up to 15 months | 
| The climacteric symptoms comparing the 2 arms. | self reported of hot flash, fatigue and weakness | from March 2014 up to 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleeping quality, menopause, climacteric, progestin, dydrogesterone, micronized progesterone