CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 172 enrolled
Drug / intervention
Estradiol +1 moredrug
Likely dose
Estradiol 200 mgfrom 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/NCT01308814
NCT01308814Phase 3Completed

Depression, Estrogen Replacement, and Cardiovascular Health in the Perimenopause

University of North Carolina, Chapel Hill·interventional·Posted Mar 4, 2011·Updated Aug 22, 2017

In Brief

A Phase 3 clinical trial evaluating Estradiol and Placebo for Perimenopause and 2 related conditions. Completed, enrolled 172 participants across 1 site.

Detailed Summary

Study Background and Objectives: In the U.S. the majority of heart disease deaths are in women, not men. Much of the gender disparity in CVD rates relate to the burden of CV risk in women after the menopause. Depression has been associated with an increased risk for CVD morbidity and mortality. Even histories of recurrent depression in euthymic individuals are associated with elevated CV risk. Understanding the depression-CVD link may have particular relevance for women since women experience depression at a rate twice that of men. Substantial convergent evidence indicates that ovarian failure (estrogen deprivation) is one likely mechanism contributing to both CVD and depression in women. The perimenopause, a time associated with a two-fold increase in rates of depression, may provide an ideal opportunity for studying the pathophysiology of CV risk and depression in women. The primary objective of this study is to examine the prophylactic role of estradiol in the development of depressive symptoms and the progression of cardiovascular risk in perimenopausal women with or without histories of depression. The investigators predict that women susceptible to depression will be particularly vulnerable to the acceleration of CVD in the context of the perimenopause and, consequently, will show differentially greater benefit of estradiol treatment during the menopause transition for both indices of CV risk (e.g. inflammation, endothelial function, stress reactivity), as well as depressive symptoms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 4, 2011
Enrollment StartOct 1, 2010
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 15.3 years ago

Interventions

Estradioldrug

Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered.

Placebodrug

Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months.