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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00668603
First Posted: April 29, 2008
Last Update Posted: February 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Päivikki and Sakari Sohlberg Foundation, Finland
Emil Aaltonen Foundation
Finnish Medical Foundation
Information provided by (Responsible Party):
Tomi S. Mikkola, Helsinki University
  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 (Participant, 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 Tomi S. Mikkola, Helsinki University:

Primary Outcome Measures:
  • Vascular function [ Time Frame: 0 and 6 months ]

Secondary Outcome Measures:
  • Cardiac and sympathetic function [ Time Frame: 0 and 6 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   48 Years to 55 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00668603


Locations
Finland
Helsinki University Hospital, Department of Obstetrics and Gynecology
Helsinki, Finland, 00029 HUS
Sponsors and Collaborators
Helsinki University
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tomi S. Mikkola, Associate Professor, Helsinki University
ClinicalTrials.gov Identifier: NCT00668603     History of Changes
Other Study ID Numbers: U1030N1016
HUS-231911
First Submitted: April 24, 2008
First Posted: April 29, 2008
Last Update Posted: February 19, 2016
Last Verified: February 2016

Keywords provided by Tomi S. Mikkola, Helsinki University:
Postmenopausal vasomotor symptoms
Hot flush
Vascular function
Cardiac function
Cardiovascular risk factor

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