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

February 18, 2016 updated by: Tomi S. Mikkola, University of Helsinki

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029 HUS
        • Helsinki University Hospital, Department of Obstetrics and Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Postmenopausal women with severe vasomotor symptoms
Drug: 17-b-estradiol
2mg oral daily for 6 months
Drug: 17-b-estradiol + medroxyprogeterone acetate
2mg E2 + 5mg MPA daily for 6 months
Other Names:
  • Indivina
Drug: 17-b-estradiol hemihydrate
1 mg skin gel daily for 6 months
Other Names:
  • Divigel
Drug: placebo pill + gel
placebo daily for 6 months
Experimental: 1
Postmenopausal women without vasomotor symptoms
Drug: 17-b-estradiol
2mg oral daily for 6 months
Drug: 17-b-estradiol + medroxyprogeterone acetate
2mg E2 + 5mg MPA daily for 6 months
Other Names:
  • Indivina
Drug: 17-b-estradiol hemihydrate
1 mg skin gel daily for 6 months
Other Names:
  • Divigel
Drug: placebo pill + gel
placebo daily for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vascular function
Time Frame: 0 and 6 months
0 and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiac and sympathetic function
Time Frame: 0 and 6 months
0 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Collaborators

Päivikki and Sakari Sohlberg Foundation, Finland
Finnish Medical Foundation
Emil Aaltonen Foundation

Investigators

  • Principal Investigator: Tomi S Mikkola, MD, Associate Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

April 24, 2008

First Submitted That Met QC Criteria

April 24, 2008

First Posted (Estimate)

April 29, 2008

Study Record Updates

Last Update Posted (Estimate)

February 19, 2016

Last Update Submitted That Met QC Criteria

February 18, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1030N1016
  • HUS-231911

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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