COMPLETED

Estrogen Variability and Irritability During the Menopause Transition

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-06-15
Study Completion:2025-01-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05388656

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.

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

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-15
Study Completion Date2025-01-17

Study Record Updates

Study Start Date2022-06-15
Study Completion Date2025-01-17

Terms related to this study

Keywords Provided by Researchers

  • Perimenopause
  • Menopause transition
  • Estrogen
  • Stress
  • Mood
  • Irritability

Additional Relevant MeSH Terms

  • Menopause
  • Irritable Mood