Can hormone patches and pills help teens with ovarian failure?
NCT ID NCT06851754
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 185 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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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
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11 to 19 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Kidney drug tested to restart egg growth in early menopause
- Can umbilical cord stem cells revive failing ovaries?
- Major study launches to unravel mysteries of early menopause
- DNA hunt for why some women face early menopause
- Stem cell shot into ovaries aims to tame perimenopause symptoms