Estrogen Variability and Irritability During the Menopause Transition

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Estradiol; Progesterone

Criteria

Inclusion Criteria:

• Healthy women 45 - 55 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 year

• BMI between 18 - 35 kg/m^2

Exclusion Criteria:

• 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 stage 2 hypertension or higher (≥140 mmHg systolic or ≥90 mmHg diastolic)

• Liver dysfunction or disease

• Undiagnosed abnormal genital bleeding

• Type I or Type II diabetes

• Known sensitivities to the matrix patch system in Climara® or allergy to peanut oil used in Prometrium®