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Completed

NCT Number: NCT00668603

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

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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Key information

Age range

48 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital, Department of Obstetrics and Gynecology

Helsinki, 00029 HUS, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

17-b-estradiol

Drug

2mg oral daily for 6 months

17-b-estradiol + medroxyprogeterone acetate

Drug

2mg E2 + 5mg MPA daily for 6 months

Other names: Indivina

17-b-estradiol hemihydrate

Drug

1 mg skin gel daily for 6 months

Other names: Divigel

placebo pill + gel

Drug

placebo daily for 6 months

Primary outcomes

  1. Vascular function

    Time frame: 0 and 6 months

Secondary outcomes

  1. Cardiac and sympathetic function

    Time frame: 0 and 6 months

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Collaborators

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

Registry information

Official study title

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

Acronym: SYMPTOM

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Apr 29, 2008
Registry last updated
Feb 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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