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

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Helsinki University; University of Helsinki
• Collaborators: Emil Aaltonen Foundation; Finnish Medical Foundation; Päivikki and Sakari Sohlberg Foundation, Finland
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Hormones; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Postmenopausal women between ages 48-55

• Minimum of 6 months and maximum of 36 months from last menstrual period

• Postmenopausal status of these women will be confirmed by level of FSH that should exceed 30 U/l

• Eighty women must have severe vasomotor symptoms (at least seven severe or moderate hot flush attacks per day) whereas eighty comparators must be symptomless

Exclusion Criteria:

• smoking

• hysterectomy

• dyslipidemia

• overt hypertension (blood pressure > 140/90)

• diabetes

• any regular medication

• HT in the previous 3 months

• body mass index over 27