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Can stabilizing hormones ease premenstrual depression? new study investigates

NCT ID NCT06610305

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how natural ups and downs of estrogen and progesterone during the menstrual cycle affect mood and the ability to feel pleasure in women whose depression gets worse before their period. Researchers will give 75 women hormone patches and pills to temporarily stabilize these hormones, then measure brain activity and mood changes. The goal is to understand the link between hormones and depression, not to test a new treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
estradiol patch and progesterone pills
What this could lead to
If successful, this could reveal how hormone changes trigger depression symptoms, pointing toward better treatments for premenstrual-related mood disorders.
What could go wrong
This is a small, early-phase study focused on understanding mechanisms, not testing a new treatment. Results may not lead to immediate therapies.

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

About 75 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Jun 2028

An estimate. End dates often move.

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

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Biologically female and between the ages of 18-45 years (45 set as upper limit to avoid endocrine changes associated with perimenopause). * Self-reported regular menstrual cycles between 25 and 35 days. * A previous diagnosis of major depressive disorder, with self-reported premenstrual worsening of symptoms. * If the woman has children, she must be at least 1 year postpartum. * English-speaking Exclusion Criteria: * Pregnant, breastfeeding, or trying to become pregnant. Pregnancy status will be confirmed using a urine pregnancy test at the enrollment visit and again at the first visit of the second condition. Women will be instructed to use a barrier method of birth control during the study. * Taking any form of exogenous hormones or IUD, and must have ended previous use of hormonal preparations at least one month prior to the study. Women who were previously taking oral contraceptives or other hormonal medications must have one normal menstrual cycle (menstrual period) prior to enrollment in the study. * BMI less than 18 or greater than 29. * A personal history of any chronic medical condition that could confound the experimental protocol, including but not limited to metabolic or autoimmune disease, epilepsy, endometriosis, cancer, diabetes, cardiovascular, gastrointestinal, hepatic, renal, pulmonary disease, migraine with aura, hypertension, Parkinson's disease, chronic pain, and thromboembolic events. * A family history indicative of increased risk of breast cancer or thromboembolic disorders. * Current cigarette smoking. * A history of mania, psychosis, or substance use disorder. * Any recent history (last 12 months) of active suicidal ideation, or suicide attempt within the last 5 years.

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Conditions

The condition(s) this trial relates to.

Depression major depressive disorder

As listed by the trial registrant

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

Major depressive disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of North Carolina, Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27707, United States

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