Comparison of Vascular Findings Between Symptomatic and Asymptomatic Postmenopausal Women Before and During Hormone Therapy (HRT) (SYMPTOM)
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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
- to compare vascular, cardiac and sympathetic function in recently menopausal women with or without severe vasomotor symptoms
- 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 |
- Vascular function [ Time Frame: 0 and 6 months ] [ Designated as safety issue: No ]
- 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 |
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| Finland | |
| Helsinki University Hospital, Department of Obstetrics and Gynecology | |
| Helsinki, Finland, 00029 HUS | |
| 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 3-benzoate Estradiol 17 beta-cypionate 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 May 16, 2013