NCT00668603|CompletedDMC
Comparison of Vascular Findings Between Symptomatic and Asymptomatic Postmenopausal Women Before and During Hormone Therapy (HRT)
SYMPTOM
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SYMPTOM
Sponsor study identifier
Secondary identifiers
interventional
160
1 country
1
Study Start
August 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2008
Actual (reported)Study Completion
March 2008
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2008
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2005
Date type not reportedThis date has not been verified as actual or estimated.
March 2008
Actual (reported)March 2008
Actual (reported)April 24, 2008
Actual (reported)April 29, 2008
Actual (reported)Vascular function
0 and 6 months
Cardiac and sympathetic function
0 and 6 months
Postmenopausal women with severe vasomotor symptoms
Postmenopausal women without vasomotor symptoms
2mg oral daily for 6 months
2mg E2 + 5mg MPA daily for 6 months
Helsinki University Hospital, Department of Obstetrics and Gynecology
Helsinki, Helsinki, 00029 HUS, Finland
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.
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.
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.
Tomi S Mikkola, MD
Associate Professor
160 participants (actual enrollment reported by the registry).
First Submitted
April 24, 2008
First Posted
April 29, 2008
Study Start
August 2005
Date type not reportedThis date has not been verified as actual or estimated.
Effect of a PPAR-Alpha Agonist on the Age Related Changes in Myocardial Metabolism and Mechanical Function
1 mg skin gel daily for 6 months
placebo daily for 6 months
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
Primary Completion
March 2008
Actual (reported)Study Completion
March 2008
Actual (reported)Last Updated
February 19, 2016
Record last verified: 2016-02
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Source: ClinicalTrials.gov.
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