CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 160 enrolled
Drug / intervention
17-b-estradiol +3 moredrug
Likely dose
17-b-estradiol 2mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00668603
NCT00668603N/ACompleted

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

University of Helsinki·interventional·Posted Apr 29, 2008·Updated Feb 19, 2016

In Brief

A clinical study evaluating 17-b-estradiol, 17-b-estradiol + medroxyprogeterone acetate, and 2 other interventions for Postmenopausal Vasomotor Symptoms and Cardiovascular Disease. Completed, enrolled 160 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFinland

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 29, 2008
Enrollment StartAug 1, 2005
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 18.2 years ago

Interventions

17-b-estradioldrug

2mg oral daily for 6 months

17-b-estradiol + medroxyprogeterone acetatedrug

2mg E2 + 5mg MPA daily for 6 months

17-b-estradiol hemihydratedrug

1 mg skin gel daily for 6 months

placebo pill + geldrug

placebo daily for 6 months