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

Cardiovascular Disease Clinical Trial

— SYMPTOM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00668603
• Other study ID #: U1030N1016
• Secondary ID: HUS-231911
• Status: Completed
• Phase: N/A
• First received: April 24, 2008
• Last updated: February 18, 2016
• Start date: August 2005
• Est. completion date: March 2008

Study information

• Verified date: February 2016
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Institutional Review BoardFinland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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, 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 48 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Postmenopausal Vasomotor Symptoms

Intervention

Drug:
• 17-b-estradiol
2mg oral daily for 6 months
• 17-b-estradiol + medroxyprogeterone acetate
2mg E2 + 5mg MPA daily for 6 months
• 17-b-estradiol hemihydrate
1 mg skin gel daily for 6 months
• placebo pill + gel
placebo daily for 6 months

Locations

Country	Name	City	State
Finland	Helsinki University Hospital, Department of Obstetrics and Gynecology	Helsinki

Sponsors (4)

Lead Sponsor	Collaborator
Helsinki University	Emil Aaltonen Foundation, Finnish Medical Foundation, Päivikki and Sakari Sohlberg Foundation, Finland

Country where clinical trial is conducted

Finland, 

References & Publications (3)

Collins P, Rosano G, Casey C, Daly C, Gambacciani M, Hadji P, Kaaja R, Mikkola T, Palacios S, Preston R, Simon T, Stevenson J, Stramba-Badiale M. Management of cardiovascular risk in the peri-menopausal woman: a consensus statement of European cardiologists and gynaecologists. Eur Heart J. 2007 Aug;28(16):2028-40. Epub 2007 Jul 20. — View Citation

Mikkola TS, Clarkson TB. Coronary heart disease and postmenopausal hormone therapy: conundrum explained by timing? J Womens Health (Larchmt). 2006 Jan-Feb;15(1):51-3. — View Citation

Mikkola TS, Clarkson TB. Estrogen replacement therapy, atherosclerosis, and vascular function. Cardiovasc Res. 2002 Feb 15;53(3):605-19. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular function		0 and 6 months	No
Secondary	Cardiac and sympathetic function		0 and 6 months	No

External Links

•   Helsinki University Hospital study registry