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Brain scans reveal why menopause makes some women snappy

NCT ID NCT05388656

Knowledge-focused Sponsor: University of North Carolina, Chapel Hill Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study involved 40 women in early menopause who reported increased irritability. Researchers gave them either estrogen patches or placebo patches to see how their brains reacted to hormone changes. The goal was to understand the brain mechanisms behind mood swings, not to test a treatment. Results may help develop better ways to manage irritability in the future.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

40 people

The number who actually took part.

Started

Jun 2022

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 to 59 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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®

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Irritable mood Menopause

Contacts and locations

Locations

  • Carolina Crossing B, Suite 1

    Chapel Hill, North Carolina, 27517, United States

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