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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| micronized progesterone | Experimental | 1 mg 17 beta-estradiol plus 100 mg micronized progesterone taken orally once a day for 3 months. |
|
| dydrogesterone | Experimental | 1mg 17 beta-estradiol plus 10 mg dydrogesterone taken orally once a day for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1mg 17 beta-estradiol | Drug | Comparing sleeping quality between micronized progesterone and dydrogesterone users. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improving of sleeping quality (assessed by the PSQI score) | from March 2014 up to 15 months |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tawiwan Pantasri, MD | Faculty of Medicine, Chiang Mai University, Thailand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obstetrics and Gynecology department, Faculty of Medicine, Chiang Mai University | Muang | Chiang Mai | 50200 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28609128 | Derived | 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. |
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| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004967 | Estrogens |
| D004394 | Dydrogesterone |
| D011374 | Progesterone |
| C000624167 | Utrogestan |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| Dydrogesterone | Drug | Comparing sleeping quality between micronised progesterone and dydrogesterone users. |
|
|
| micronized progesterone | Drug | Comparing sleeping quality between micronised progesterone and dydrogesterone users |
|
|
self reported of hot flash, fatigue and weakness
| from March 2014 up to 15 months |
| D011083 |
| Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D003339 | Corpus Luteum Hormones |
| D045167 | Progesterone Congeners |