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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 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. The trial reports 1 study location across 1 state.
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.
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
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06851754
The ClinicalTrials.gov registry entry for NCT06851754 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 185 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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