Status:
COMPLETED
Comparison of Vascular Findings Between Symptomatic and Asymptomatic Postmenopausal Women Before and During Hormone Therapy (HRT)
Lead Sponsor:
University of Helsinki
Collaborating Sponsors:
Päivikki and Sakari Sohlberg Foundation, Finland
Emil Aaltonen Foundation
Conditions:
Postmenopausal Vasomotor Symptoms
Cardiovascular Disease
Eligibility:
FEMALE
48-55 years
Phase:
NA
Brief Summary
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, recent...
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 mu...
Eligibility Criteria
Inclusion
- 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
- smoking
- hysterectomy
- dyslipidemia
- overt hypertension (blood pressure \> 140/90)
- diabetes
- any regular medication
- HT in the previous 3 months
- body mass index over 27
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00668603
Start Date
August 1 2005
End Date
March 1 2008
Last Update
February 19 2016
Active Locations (1)
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1
Helsinki University Hospital, Department of Obstetrics and Gynecology
Helsinki, Helsinki, Finland, 00029 HUS