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Melatonin shows promise for perimenopause symptoms in small trial

NCT ID NCT06192641

Symptom relief Sponsor: Univates 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether taking 3 mg of melatonin at bedtime for 30 days can ease common perimenopause symptoms like sleep problems, mood changes, and pain. Twenty-four women aged 45 and older with irregular periods participated. The goal is to see if melatonin offers a simple, non-hormonal way to feel better during this transition.

What this could mean

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

Active substance
melatonin
What this could lead to
If it works, this could point toward a simple, non-hormonal option to ease common perimenopause symptoms like poor sleep, mood changes, and pain.
What could go wrong
This is a very small, early-phase trial with only 24 participants. Results may not apply to all women, and melatonin's effects could be mild or no better than placebo.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

24 people

The number who actually took part.

Started

Oct 2023

Finished

Dec 2024

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 years and older

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:- Being female and in peri-menopause, experiencing an irregular menstrual cycle, having had at least one menstrual period in the last 6 months. * Age 45 years or older * Be literate Exclusion Criteria:-History of alcohol or other substance abuse in the last 6 months * Use of hormonal therapy; * Neurological disease; * Oncological disease; * Ischemic heart disease; * Liver failure; * Renal insufficiency; * Use of central nervous system medications (antidepressants, anticonvulsants, antipsychotics and benzodiazepines)

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As listed by the trial registrant

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

Perimenopausal disorder

Contacts and locations

Locations

  • Gabriela Laste

    Lajeado, Rio Grande do Sul, 95900-000, Brazil

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