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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2008-03-31

Brief Summary

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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.

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Detailed Description

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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

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Postmenopausal Vasomotor Symptoms Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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2

Postmenopausal women with severe vasomotor symptoms

Group Type EXPERIMENTAL

17-b-estradiol

Intervention Type DRUG

2mg oral daily for 6 months

17-b-estradiol + medroxyprogeterone acetate

Intervention Type DRUG

2mg E2 + 5mg MPA daily for 6 months

17-b-estradiol hemihydrate

Intervention Type DRUG

1 mg skin gel daily for 6 months

placebo pill + gel

Intervention Type DRUG

placebo daily for 6 months

1

Postmenopausal women without vasomotor symptoms

Group Type EXPERIMENTAL

17-b-estradiol

Intervention Type DRUG

2mg oral daily for 6 months

17-b-estradiol + medroxyprogeterone acetate

Intervention Type DRUG

2mg E2 + 5mg MPA daily for 6 months

17-b-estradiol hemihydrate

Intervention Type DRUG

1 mg skin gel daily for 6 months

placebo pill + gel

Intervention Type DRUG

placebo daily for 6 months

Interventions

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17-b-estradiol

2mg oral daily for 6 months

Intervention Type DRUG

17-b-estradiol + medroxyprogeterone acetate

2mg E2 + 5mg MPA daily for 6 months

Intervention Type DRUG

17-b-estradiol hemihydrate

1 mg skin gel daily for 6 months

Intervention Type DRUG

placebo pill + gel

placebo daily for 6 months

Intervention Type DRUG

Other Intervention Names

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Indivina Divigel

Eligibility Criteria

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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

Minimum Eligible Age

48 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes