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
  Purpose

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.

Condition Intervention
Postmenopausal Vasomotor Symptoms
Cardiovascular Disease
Drug: 17-b-estradiol
Drug: 17-b-estradiol + medroxyprogeterone acetate
Drug: 17-b-estradiol hemihydrate
Drug: placebo pill + gel

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Vascular Findings Between Symptomatic and Asymptomatic Postmenopausal Women Before and During Hormone Therapy: A Randomized, Placebo-Controlled Prospective Study

Resource links provided by NLM:


Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • Vascular function [ Time Frame: 0 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiac and sympathetic function [ Time Frame: 0 and 6 months ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: August 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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: 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 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

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.

  Eligibility

Ages Eligible for Study:   48 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668603

Locations
Finland
Helsinki University Hospital, Department of Obstetrics and Gynecology
Helsinki, Finland, 00029 HUS
Sponsors and Collaborators
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
Investigators
Principal Investigator: Tomi S Mikkola, MD Associate Professor
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tomi S. Mikkola/ Associate Professor
ClinicalTrials.gov Identifier: NCT00668603     History of Changes
Other Study ID Numbers: U1030N1016, HUS-231911
Study First Received: April 24, 2008
Last Updated: April 24, 2008
Health Authority: Finland: Institutional Review Board
Finland: Finnish Medicines Agency

Keywords provided by Helsinki University:
Postmenopausal vasomotor symptoms
Hot flush
Vascular function
Cardiac function
Cardiovascular risk factor

Additional relevant MeSH terms:
Cardiovascular Diseases
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on September 18, 2014