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NCT06851754 · ClinicalTrials.gov registry record · Phase 3
Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency
A Phase 3 study of Premature Ovarian Insufficiency, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Recruiting
- Registry status
- Phase 3
- Development phase
- 185
- Enrollment target
- 1
- Study location
NCT06851754: Recruiting Phase 3 study of Premature Ovarian Insufficiency, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT06851754 is a Phase 3 study of Premature Ovarian Insufficiency that is actively recruiting participants, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 185 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06851754, a Phase 3 study of Premature Ovarian Insufficiency, is actively recruiting participants, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 185 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
measures of bone health, dual-energy x-ray absorptiometry (DXA) measures of skeletal sites other than the spine (DXA - hip/total body) will be evaluated longitudinally in POI participants and their BMD compared to healthy control participants. Using DXA, vertebral fractures assessment (VFA) will be performed in POI participants and compared to healthy control participants. In addition, BMD will be evaluated with respect to skin pigmentation and muscle grip strength.
Conditions Studied
Interventions
- DRUG Progesterone
- DRUG Estrogen Patch
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 185 participants |
| Start Date | 2025-07-17 |
| Est. Completion | 2031-12-31 |
| Phase | Phase 3 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What NCT06851754 shows while recruiting
NCT06851754 is an interventional study that assigns participants to a tested intervention. The registered 185 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Premature Ovarian Insufficiency appearing as the primary indexed condition, and to 2 interventions - of which Progesterone is the first listed.
NCT06851754 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06851754 about?
NCT06851754 is a clinical study titled "Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency". 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 ext...
What is the current status of trial NCT06851754?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 185 participants. The study started on 2025-07-17. Estimated completion is 2031-12-31.
What conditions does trial NCT06851754 study?
This clinical trial studies the following conditions: Premature Ovarian Insufficiency.
What interventions are being tested in trial NCT06851754?
The interventions under investigation include: Progesterone (DRUG), Estrogen Patch (DRUG).
Who is sponsoring clinical trial NCT06851754?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06851754 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06851754's enrollment target sits among peer trials
185 1418th of 2000 higher than 583 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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