Estrogen Variability and Irritability During the Menopause Transition

Description

Women in the menopause transition (perimenopause) experience substantial day-to-day variability in estradiol and have a 2-4-fold increase in major depression risk. About 40% of perimenopausal women are susceptible to the emergence of affective symptoms tied to changes in estradiol. Among the perimenopausal women with affective impairment, most report irritability, not "depression," is their primary source of impairment and distress. The purpose of this research is to determine the neurophysiologic basis of susceptibility to estradiol fluctuations and irritability symptoms in perimenopausal women.

Conditions

Menopause, Irritable Mood

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Study Overview

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Study Details

Study overview

Women in the menopause transition (perimenopause) experience substantial day-to-day variability in estradiol and have a 2-4-fold increase in major depression risk. About 40% of perimenopausal women are susceptible to the emergence of affective symptoms tied to changes in estradiol. Among the perimenopausal women with affective impairment, most report irritability, not "depression," is their primary source of impairment and distress. The purpose of this research is to determine the neurophysiologic basis of susceptibility to estradiol fluctuations and irritability symptoms in perimenopausal women.

Identifying Neurophysiological Mechanisms of Susceptibility to Estradiol Fluctuation and Irritability Symptoms in the Menopause Transition: An Experimental Approach

Estrogen Variability and Irritability During the Menopause Transition

Condition
Menopause
Intervention / Treatment

-

Contacts and Locations

Chapel Hill

Carolina Crossing B, Suite 1, Chapel Hill, North Carolina, United States, 27517

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Healthy women 45 - 59 years of age
  • * In the early menopause transition (defined by variable menstrual cycle length that is 7+ days longer or shorter than usual)
  • * Increase in irritability since the onset of menstrual cycle changes
  • * Moderate to severe irritability symptoms, as defined by IDAS ill-temper scale score \>10
  • * Have experienced 1+ very stressful life event (e.g. divorce, death of family member) within the past 6 months
  • * Negative mammogram within the past two years
  • * BMI between 18 - 45 kg/m\^2
  • * Use of psychotropic agents or hormonal preparations, or herbal supplements (other than multivitamins) believed to affect mood or menopausal symptoms
  • * History of psychosis, bipolar disorder, or substance dependence
  • * Active psychological symptoms severe enough to require treatment
  • * Current suicidal intent or recent history of suicide attempts (within past 10 years)
  • * Personal or family history of cancer indicative of more than average risk for breast, ovarian or endometrial cancers
  • * Personal history of any cardiovascular disease including coronary artery disease, arteriosclerosis, heart attack, stroke
  • * Personal history of thromboembolic disorders
  • * History of E2-dependent neoplasia
  • * History of gallbladder disease
  • * Recent history of migraine with aura
  • * Blood pressure classified as higher than stage 2 hypertension (≥160 mmHg systolic or ≥100 mmHg diastolic)
  • * Liver dysfunction or disease
  • * Undiagnosed abnormal genital bleeding
  • * Type I diabetes
  • * Known sensitivities to the matrix patch system in Climara® or allergy to peanut oil used in Prometrium®

Ages Eligible for Study

45 Years to 59 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of North Carolina, Chapel Hill,

Susan Girdler, PhD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Elizabeth Andersen, PhD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

2024-12