Trial | NCT00668603  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    estradiol medroxyprogesterone ...

  • Study Participants

    160
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.
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.
Study Started
Aug 31
2005
Primary Completion
Mar 31
2008
Study Completion
Mar 31
2008
Last Update
Feb 19
2016
Estimate

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 names: Indivina

Drug 17-b-estradiol hemihydrate

1 mg skin gel daily for 6 months

  • Other names: Divigel

Drug placebo pill + gel

placebo daily for 6 months

2 Experimental

Postmenopausal women with severe vasomotor symptoms

1 Experimental

Postmenopausal women without vasomotor symptoms

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
No Results Posted