NCT00668603

Comparison of Vascular Findings Between Symptomatic and Asymptomatic Postmenopausal Women Before and During Hormone Therapy (HRT)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: University of Helsinki · Academic / Other
• Sex: Female
• Age: 48 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Postmenopausal Vasomotor Symptoms
• Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	17-b-estradiol	2mg oral daily for 6 months
DRUG	17-b-estradiol + medroxyprogeterone acetate	2mg E2 + 5mg MPA daily for 6 months
DRUG	17-b-estradiol hemihydrate	1 mg skin gel daily for 6 months
DRUG	placebo pill + gel	placebo daily for 6 months

Timeline

• Start date: 2005-08-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2008-04-29
• Last updated: 2016-02-19

Locations

1 site across 1 country: Finland