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MinorEligibility criteria expanded, about 16 words
Minor5 versionsRe-verified since Jun 13, 2026, no change to tracked fieldsv107-v111
MinorEligibility criteria shortened, about 1 wordv106
Minor2 versionsRe-verified since Apr 21, 2026, no change to tracked fieldsv104-v105
MinorStudy Status, Eligibilityv103
Show 40 earlier versionsHide 40 earlier versions
NotablePhase: Early Phase 1 to Phase 3v102
Minor7 versionsRe-verified since Sep 6, 2025, no change to tracked fieldsv95-v101
MinorStart date changed from estimate of Jul 22, 2025 to Jul 17, 2025v94
MinorStart date: Jul 21, 2025 to Jul 22, 2025v93
MinorStart date: Jul 18, 2025 to Jul 21, 2025v92
MinorStart date: Jul 17, 2025 to Jul 18, 2025v91
MinorStart date: Jul 16, 2025 to Jul 17, 2025v90
MinorStart date: Jul 15, 2025 to Jul 16, 2025v89
MinorStart date: Jul 14, 2025 to Jul 15, 2025v88
MinorStart date: Jul 13, 2025 to Jul 14, 2025v87
MinorStart date: Jul 9, 2025 to Jul 13, 2025v86
MinorStart date: Jul 8, 2025 to Jul 9, 2025v85
MinorStart date: Jul 7, 2025 to Jul 8, 2025v84
MinorStart date: Jul 6, 2025 to Jul 7, 2025v83
MinorStart date: Jul 3, 2025 to Jul 6, 2025v82
MinorStart date: Jul 2, 2025 to Jul 3, 2025v81
MinorStart date: Jul 1, 2025 to Jul 2, 2025v80
MinorStart date: Jun 30, 2025 to Jul 1, 2025v79
MinorStart date: Jun 29, 2025 to Jun 30, 2025v78
MinorStart date: Jun 26, 2025 to Jun 29, 2025v77
MinorStart date: Jun 24, 2025 to Jun 26, 2025v76
MinorStart date: Jun 23, 2025 to Jun 24, 2025v75
MinorStart date: Jun 20, 2025 to Jun 23, 2025v74
MinorStart date: Jun 19, 2025 to Jun 20, 2025v73
MinorStart date: Jun 18, 2025 to Jun 19, 2025v72
MinorStart date: Jun 17, 2025 to Jun 18, 2025v71
MinorStart date: Jun 16, 2025 to Jun 17, 2025v70
MinorStart date: Jun 15, 2025 to Jun 16, 2025v69
MinorStart date: Jun 12, 2025 to Jun 15, 2025v68
MinorStart date: Jun 11, 2025 to Jun 12, 2025v67
MinorStart date: Jun 10, 2025 to Jun 11, 2025v66
NotableTrial status: Not Yet Recruiting to Recruiting
Start date: Jun 9, 2025 to Jun 10, 2025
v65
MinorStart date: Jun 8, 2025 to Jun 9, 2025v64
MinorStart date: Jun 5, 2025 to Jun 8, 2025v63
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background:
Premature ovarian insufficiency (POI) is a condition in which women under the age of 40 years have absent or irregular menstrual cycles. POI can cause infertility, signs of menopause, osteoporosis, and other symptoms. Hormone replacement therapy (HRT) is a treatment that gives women extra hormones, such as estrogen and progesterone. HRT works well in adult women. Researchers want to find the most effective doses and regimens for adolescents.
Objective:
To monitor the effects of HRT on adolescents with POI.
Eligibility:
Female adolescents aged 11 to 19 years diagnosed with POI. Healthy volunteers are also needed.
Design:
All participants will have clinic visits every 6 months for 2 years. Each visit may last 2 days. Each visit may include:
Blood and urine tests.
A test of their heart function.
A test to measure the stiffness of their blood vessels. Participants will lie flat with a blood pressure cuff on a leg and a meter on the neck while the cuff inflates.
A test of their grip strength. Participants will squeeze a handheld device as hard as they can.
Two scans to measure bone density. For one, participants will lie on a table while a scanner passes along their body. For the other, participants will sit in a chair and insert their forearm, then their lower leg, into a scanner.
A test to measure skin pigmentation. Participants' skin will be touched lightly with a device.
An optional visual exam of the vagina. Some vaginal fluid may also be collected with a cotton swab/cytobrush.
Participants with POI will receive HRT. They will be given estrogen patches and progesterone pills.