Status:
COMPLETED
Estrogen Variability and Irritability During the Menopause Transition
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Menopause
Irritable Mood
Eligibility:
FEMALE
45-59 years
Phase:
PHASE4
Brief 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 ar...
Detailed Description
Using a within-subjects, cross-over design and transdermal estradiol to stabilize estradiol fluctuations (and increase levels) the investigators will test if neural dynamics (oscillatory activity in t...
Eligibility Criteria
Inclusion
- Healthy women 45 - 59 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 two years
- BMI between 18 - 45 kg/m\^2
Exclusion
- 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 higher than stage 2 hypertension (≥160 mmHg systolic or ≥100 mmHg diastolic)
- Liver dysfunction or disease
- Undiagnosed abnormal genital bleeding
- Type I diabetes
- Known sensitivities to the matrix patch system in Climara® or allergy to peanut oil used in Prometrium®
Key Trial Info
Start Date :
June 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05388656
Start Date
June 15 2022
End Date
January 17 2025
Last Update
November 26 2025
Active Locations (1)
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1
Carolina Crossing B, Suite 1
Chapel Hill, North Carolina, United States, 27517