drugset / Trial / NCT05388656
Estrogen Variability and Irritability During the Menopause Transition
Phase 4
Completed
40 enrolled
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH) · collab
RandomizedCrossoverQuadruple-blindBasic science
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.
Timeline
- Start
- 2022-06-15
- Primary completion
- 2024-12-17
- Completion
- 2025-01-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Estradiol | Other / unclassified | 0.1 mg | Other |
| Background | Progesterone | Other / unclassified | 200 mg | Oral |