Comparison of Vascular Findings Between Symptomatic and Asymptomatic Postmenopausal Women Before and During Hormone Therapy: A Randomized, Placebo-controlled Prospective Study (SYMPTOM)

NCT00668603 NA COMPLETED

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 1. to compare vascular, cardiac and sympathetic function in recently menopausal women with or without severe vasomotor symptoms 2. in a randomized placebo controlled clinical trial investigate vascular response to oral and trans-dermal HT.

Details

Lead sponsor	University of Helsinki
Phase	NA
Status	COMPLETED
Enrolment	160
Start date	2005-08
Completion	2008-03

Conditions

• Postmenopausal Vasomotor Symptoms
• Cardiovascular Disease

Interventions

• 17-b-estradiol
• 17-b-estradiol + medroxyprogeterone acetate
• 17-b-estradiol hemihydrate
• placebo pill + gel

Primary outcomes

• Vascular function — 0 and 6 months

Countries

Finland