The Menopause Transition: Estrogen Variability, Stress Reactivity and Mood

• Status: Terminated
• Trial end date: 2020-05-10
• Target enrollment: 0
• Participant gender: Female

Summary

Women in the menopause transition ('perimenopause') are exposed to extreme hormone variability, tend to experience a unique set of severe stressors (e.g., divorce, death of loved ones), and are also at substantially elevated risk to suffer from mood and anxiety disorders. The purpose of this research is to understand the mechanisms by which variability in estradiol (E2) is associated with the symptoms of anxiety and anhedonia (loss of interest and pleasure - a common symptom of depression). By stabilizing E2 variability with a hormonal manipulation, this research will determine the degree to which the E2 variability (or E2 levels) plays a causal role in perimenopausal anxiety and anhedonia symptoms and whether it does so by affecting biological responses to stress.

• 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; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Estrogens; Polyestradiol phosphate; Progesterone

Criteria

Inclusion Criteria:

• Perimenopausal (either early perimenopause, defined as menstrual cycle length 7+ days longer or shorter than usual; or the late perimenopause, defined as ≥2 skipped cycles and an interval of amenorrhea ≥60 days but within one year of the last menstrual period)

• 45 to 60 years of age

• must be medically healthy

Exclusion Criteria:

• a history of cardiovascular disease (CVD) including coronary artery disease, arteriosclerosis, heart attack, or stroke

• Type I or II diabetes

• personal history of thrombotic events

• personal or family history suggesting elevated risk for E2-related cancer

• currently experiencing migraine headaches with aura