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Can hormone patches and pills help teens with ovarian failure?

NCT ID NCT06851754

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 9 times

Summary

This study looks at how hormone replacement therapy (HRT) affects adolescents aged 11-19 with premature ovarian insufficiency (POI), a condition where ovaries stop working before age 40. Participants receive estrogen patches and progesterone pills over 2 years, with regular check-ups to monitor bone health, heart function, and other measures. The goal is to find the best HRT approach for this age group.

What this could mean

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

Active substance
Estrogen patch and progesterone pill
What this could lead to
If successful, this could establish safe and effective hormone replacement therapy guidelines for adolescents with premature ovarian insufficiency, improving bone density and overall health.
What could go wrong
This is a phase 3 trial, but it is observational in nature and does not compare different treatments. Results may not apply to all patients, and side effects from hormones are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 185 people

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

Started

Jul 2025

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Ages

11 to 19 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: Inclusion Criteria for POI Participants To be eligible to participate in this study, an individual must meet all the following criteria: 1. Individuals aged 11-19 years, inclusive, at the time of enrollment. 2. Diagnosis of premature ovarian insufficiency. 3. Documentation of one elevated serum FSH measurement greater than the testing laboratory's upper reference range (for age/Tanner stage). 4. Identify as female (i.e., sex assigned at birth) 5. Negative pregnancy test. Inclusion Criteria for Healthy Volunteers: 1. Individuals aged 11-19 years. 2. Identify as female (i.e., sex assigned at birth) 3. Negative pregnancy test. 4. Absence of known chronic disease EXCLUSION CRITERIA: Male participants are excluded from both study groups (POI and Healthy Volunteers) as POI affects only the female reproductive system, while pregnant participants are not eligible to have DXA or HRpQCT imaging for safety reasons. Exclusion Criteria for POI participants: An individual who meets any of the following criteria will be excluded from participation in this study: 1. POI in the setting of Turner syndrome. 2. Patients who screened positive for celiac disease. 3. Receipt of any medications including HRT determined by the investigator to affect bone metabolism 3 months prior to enrollment. 4. Any medical condition determined by the investigator to affect bone health will be excluded. 5. Presence of a medical, psychiatric, or social condition which, in the opinion of the investigator, would place undue burden on the subject, NIH resources, or increase risk of participation. 6. Report of sexual activity but refusal to use a copper intrauterine device or double barrier forms of contraception during the study. Exclusion Criteria for Healthy Volunteers: For healthy volunteers, all exclusion criteria will apply as for POI participants except for number 1.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

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