Perimenopausal Estrogen Replacement Therapy Study (PERT)

University of North Carolina (UNC)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Menopause; Depression; Perimenopause

Treatments: Drug: Estradiol; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01308814

10-0542

R01MH087619 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 172 patients

Sex: Female

Ages: 45 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• must be between 45 and 60 years of age
• must be in the menopause transition (irregular/ absent menstrual cycles or hot flashes)
• must be are medically healthy

Exclusion criteria

• currently taking antidepressant medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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172 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo patches for 12 months and placebo pills for 12 days every 2 months.

Treatment:

Drug: Placebo

Estradiol

Experimental group

Description:

Transdermal 17β-estradiol (100 ug/day) for 12 months and oral micronized progesterone (200 mg/day) for 12 days every two months.

Treatment:

Drug: Estradiol