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

Not Applicable

Completed

• Conditions: Postmenopausal Vasomotor Symptoms; Cardiovascular Disease
• Interventions: Drug: 17-b-estradiol; Drug: 17-b-estradiol + medroxyprogeterone acetate; Drug: 17-b-estradiol hemihydrate; Drug: placebo pill + gel

• Registration Number: NCT00668603
• Lead Sponsor: University of Helsinki

Brief 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.

Study Timeline

• Study Start: 2005-08
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Study First Submitted: 2008-04-24
• Study First Submitted QC: 2008-04-24
• Study First Posted: 2008-04-29
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-18
• Last Update Posted: 2016-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	17-b-estradiol	Postmenopausal women with severe vasomotor symptoms
2	17-b-estradiol + medroxyprogeterone acetate	Postmenopausal women with severe vasomotor symptoms
2	17-b-estradiol hemihydrate	Postmenopausal women with severe vasomotor symptoms
2	placebo pill + gel	Postmenopausal women with severe vasomotor symptoms
1	17-b-estradiol	Postmenopausal women without vasomotor symptoms
1	17-b-estradiol + medroxyprogeterone acetate	Postmenopausal women without vasomotor symptoms
1	17-b-estradiol hemihydrate	Postmenopausal women without vasomotor symptoms
1	placebo pill + gel	Postmenopausal women without vasomotor symptoms

Primary Outcome Measures

Name	Time	Method
Vascular function	0 and 6 months

Secondary Outcome Measures

Name	Time	Method
Cardiac and sympathetic function	0 and 6 months

Trial Locations

Locations (1)

Helsinki University Hospital, Department of Obstetrics and Gynecology; 🇫🇮 Helsinki, Finland