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

This study has been completed.
Sponsor:
Collaborators:
Finnish governmental support for health sciences
Finnish Society for Menopause Research
Päivikki and Sakari Sohlberg Foundation, Finland
Emil Aaltonen Foundation
Finnish Medical Foundation
Information provided by:
Helsinki University
ClinicalTrials.gov Identifier:
NCT00668603
First received: April 24, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted

April 24, 2008
April 24, 2008
August 2005
March 2008   (final data collection date for primary outcome measure)
Vascular function [ Time Frame: 0 and 6 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Cardiac and sympathetic function [ Time Frame: 0 and 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Vascular Findings Between Symptomatic and Asymptomatic Postmenopausal Women Before and During Hormone Therapy (HRT)
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Postmenopausal Vasomotor Symptoms
  • Cardiovascular Disease
  • 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 Name: Indivina
  • Drug: 17-b-estradiol hemihydrate
    1 mg skin gel daily for 6 months
    Other Name: Divigel
  • Drug: placebo pill + gel
    placebo daily for 6 months
  • Experimental: 2
    Postmenopausal women with severe vasomotor symptoms
    Interventions:
    • Drug: 17-b-estradiol
    • Drug: 17-b-estradiol + medroxyprogeterone acetate
    • Drug: 17-b-estradiol hemihydrate
    • Drug: placebo pill + gel
  • Experimental: 1
    Postmenopausal women without vasomotor symptoms
    Interventions:
    • Drug: 17-b-estradiol
    • Drug: 17-b-estradiol + medroxyprogeterone acetate
    • Drug: 17-b-estradiol hemihydrate
    • Drug: placebo pill + gel

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
March 2008
March 2008   (final data collection date for primary outcome measure)

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
Female
48 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00668603
U1030N1016, HUS-231911
Yes
Tomi S. Mikkola/ Associate Professor
Helsinki University
  • Finnish governmental support for health sciences
  • Finnish Society for Menopause Research
  • Päivikki and Sakari Sohlberg Foundation, Finland
  • Emil Aaltonen Foundation
  • Finnish Medical Foundation
Principal Investigator: Tomi S Mikkola, MD Associate Professor
Helsinki University
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP