drugset / Trial / NCT03003949

The Menopause Transition: Estrogen Variability, Stress Reactivity and Mood

NCT03003949

RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2017-01-24
Primary completion
2020-05-10
Completion
2020-05-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Estradiol Other / unclassified 0.1 mg Other
Comparator Progesterone Other / unclassified 200 mg Oral

Indications

No indication recorded.