Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Early menopause heart risk under microscope: hormone Therapy's role questioned

NCT ID NCT04167033

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how early menopause (premature ovarian insufficiency) affects the heart's electrical signals, which can raise the risk of dangerous heart rhythms. Researchers will compare 120 women with and without this condition, and also check how hormone replacement therapy changes these signals. The goal is to understand if these women need special heart monitoring.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

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

Started

Apr 2021

Expected to finish

Jun 2027

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 40 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: Patients with POI * Patient aged 18 to 41 years * Patient with POI diagnostic criteria (FSH \>25UI/l twice at intervals of a few weeks) with amenorrhea * No hormone treatment interacting with the gonadotropic axis for at least one month before inclusion * Patient who has signed informed consent * Patient affiliated to a social security system Healthy volunteers (including POI control group) * Healthy women, aged 18 to 40 years, age-matched (+/- 5 years), and by BMI class (BMI\<18, 18-25, 25-30, 30-35, 35-40, \>40) compared to women with BPI * Women with regular cycles of 26 to 32 days * Women who has signed an informed consent form * Patient affiliated to a social security system Exclusion Criteria: Patients with POI * Patient on HRT during the 1st evaluation * Pregnant or breastfeeding woman * Treatment regimen known to lengthen QT or act on ventricular repolarization * Cardiac history in particular cardiac rhythm disorder * Diabetes * Patient on AME (unless derogation from affiliation), * Severe renal insufficiency (MDRD \<30ml/min/m²) Healthy volunteers (including POI control group) * Diabetes or any chronic disease (including cardiovascular and endocrine) * Pregnant or breastfeeding woman * Hormonal contraceptive treatment in progress or stopped less than 3 months ago * Chronic treatment affecting the duration of QTc * Woman under AME (unless affiliation derogation)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Premature ovarian insufficiency are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

primary ovarian failure torsades de pointes

As listed by the trial registrant

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

Premature ovarian insufficiency

How to take part

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

  1. The places running it

    2 sites. 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

  • BACHELOT

    RECRUITING

    Paris, 75013, France

  • Hopital Haut Leveque

    ACTIVE_NOT_RECRUITING

    Bordeaux, France

  • Pitié Salpêtrière

    RECRUITING

    Paris, 75013, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.