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Estrogen Variability and Irritability During the Menopause Transition

NCT05388656 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-11-26

Study results available
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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.

Conditions

Interventions

DRUG

Estradiol Patch, 0.1 mg/24 Hours Weekly Transdermal Film, Extended Release

0.1 mg/day transdermal patch administered for 3 weeks

DRUG

Placebo

Estradiol-matched placebo patch administered for 3 weeks

DRUG

Progesterone 200 mg

200 mg tablet administered by mouth once per day for 10 days after completion of the experimental phase of the study

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Susan Girdler, PhD · University of North Carolina, Chapel Hill

  • Elizabeth Andersen, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
59 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-15
Primary Completion
2024-12-17
Completion
2025-01-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05388656 on ClinicalTrials.gov