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

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.

Conditions

• Postmenopausal Vasomotor Symptoms
• Cardiovascular Disease

Interventions

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

Sponsors & Collaborators

• Päivikki and Sakari Sohlberg Foundation, Finland

  collaborator OTHER

• Emil Aaltonen Foundation

  collaborator OTHER

• Finnish Medical Foundation

  collaborator NETWORK

• University of Helsinki

  lead OTHER

Principal Investigators

• Tomi S Mikkola, MD · Associate Professor

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

48 Years

Max Age

55 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2005-08-31

Primary Completion

2008-03-31

Completion

2008-03-31

Countries

• Finland

Study Locations