Menopausal and Postmenopausal Disorders
Conditions
Keywords
Sleeping quality, menopause, climacteric, progestin, dydrogesterone, micronized progesterone
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.
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.
Interventions
DRUG1mg 17 beta-estradiol
Comparing sleeping quality between micronized progesterone and dydrogesterone users.
DRUGDydrogesterone
Comparing sleeping quality between micronised progesterone and dydrogesterone users.
DRUGmicronized progesterone
Comparing sleeping quality between micronised progesterone and dydrogesterone users
Sponsors
Chiang Mai University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improving of sleeping quality (assessed by the PSQI score) | from March 2014 up to 15 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The side effects comparing the 2 arms. | from March 2014 up to 15 months | Acne,melanoma, breast tenderness, abnormal vaginal bleeding, weight change |
| The climacteric symptoms comparing the 2 arms. | from March 2014 up to 15 months | self reported of hot flash, fatigue and weakness |
Countries
Thailand
Outcome results
None listed