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| ID | Type | Description | Link |
|---|---|---|---|
| HUS-231911 |
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| Name | Class |
|---|---|
| Päivikki and Sakari Sohlberg Foundation, Finland | OTHER |
| Emil Aaltonen Foundation | OTHER |
| Finnish Medical Foundation | NETWORK |
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Recent large randomized, placebo-controlled studies assessing the health effects of HT question the overall benefits of long term HT, especially with respect to cardiovascular disease. However, recently menopausal women with severe hot flushes were mostly excluded from these trials. This was unfortunate since vasomotor symptoms may reflect different vascular sensitivity to estrogen or its deficiency, and therefore, the vascular responses to HT in women with and without hot flushes can differ.
Aims of the present project are
We recruit 160 healthy postmenopausal women between ages 48-55. Eighty women must have severe vasomotor symptoms (at least seven severe or moderate hot flush attacks per day) whereas 80 comparators must be symptomless (no hot flushes). Thorough vascular function and risk factor assessments will be done, including clinical assessment of autonomic nervous system, endothelial function measurements, 24-hour ECG and blood pressure evaluation, and lipid and various other vascular surrogate marker measurements. In the first part of the study we compare these baseline measurements between women with or without severe vasomotor symptoms. In the second part of the study the women are randomized to receive placebo, oral estrogen, oral estrogen plus progestin or transdermal estrogen for 6 months. After the treatments the baseline assessments are repeated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Experimental | Postmenopausal women with severe vasomotor symptoms |
|
| 1 | Experimental | Postmenopausal women without vasomotor symptoms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 17-b-estradiol | Drug | 2mg oral daily for 6 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Vascular function | 0 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac and sympathetic function | 0 and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomi S Mikkola, MD | Associate Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital, Department of Obstetrics and Gynecology | Helsinki | Helsinki | 00029 HUS | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11861031 | Background | Mikkola TS, Clarkson TB. Estrogen replacement therapy, atherosclerosis, and vascular function. Cardiovasc Res. 2002 Feb 15;53(3):605-19. doi: 10.1016/s0008-6363(01)00466-7. | |
| 16417418 | Background | Mikkola TS, Clarkson TB. Coronary heart disease and postmenopausal hormone therapy: conundrum explained by timing? J Womens Health (Larchmt). 2006 Jan-Feb;15(1):51-3. doi: 10.1089/jwh.2006.15.51. No abstract available. |
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| 17-b-estradiol + medroxyprogeterone acetate |
| Drug |
2mg E2 + 5mg MPA daily for 6 months |
|
|
| 17-b-estradiol hemihydrate | Drug | 1 mg skin gel daily for 6 months |
|
|
| placebo pill + gel | Drug | placebo daily for 6 months |
|
| 17644507 | Background | Collins P, Rosano G, Casey C, Daly C, Gambacciani M, Hadji P, Kaaja R, Mikkola T, Palacios S, Preston R, Simon T, Stevenson J, Stramba-Badiale M. Management of cardiovascular risk in the peri-menopausal woman: a consensus statement of European cardiologists and gynaecologists. Eur Heart J. 2007 Aug;28(16):2028-40. doi: 10.1093/eurheartj/ehm296. Epub 2007 Jul 20. |
| 20443719 | Derived | Tuomikoski P, Mikkola TS, Tikkanen MJ, Ylikorkala O. Hot flushes and biochemical markers for cardiovascular disease: a randomized trial on hormone therapy. Climacteric. 2010 Oct;13(5):457-66. doi: 10.3109/13697131003624656. |
| 19888035 | Derived | Tuomikoski P, Ebert P, Groop PH, Haapalahti P, Hautamaki H, Ronnback M, Ylikorkala O, Mikkola TS. Effect of hot flushes on vascular function: a randomized controlled trial. Obstet Gynecol. 2009 Oct;114(4):777-785. doi: 10.1097/AOG.0b013e3181b6f268. |
| 19305337 | Derived | Tuomikoski P, Ebert P, Groop PH, Haapalahti P, Hautamaki H, Ronnback M, Ylikorkala O, Mikkola TS. Evidence for a role of hot flushes in vascular function in recently postmenopausal women. Obstet Gynecol. 2009 Apr;113(4):902-908. doi: 10.1097/AOG.0b013e31819cac04. |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004958 | Estradiol |
| D005782 | Gels |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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