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Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 112 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Eligibility criteria expanded, about 16 words
  2. Minor 5 versions Re-verified since Jun 13, 2026, no change to tracked fieldsv107-v111
  3. Minor Eligibility criteria shortened, about 1 wordv106
  4. Minor 2 versions Re-verified since Apr 21, 2026, no change to tracked fieldsv104-v105
  5. Minor Study Status, Eligibilityv103
Show 40 earlier versionsHide 40 earlier versions
  1. Notable Phase: Early Phase 1 to Phase 3v102
  2. Minor 7 versions Re-verified since Sep 6, 2025, no change to tracked fieldsv95-v101
  3. Minor Start date changed from estimate of Jul 22, 2025 to Jul 17, 2025v94
  4. Minor Start date: Jul 21, 2025 to Jul 22, 2025v93
  5. Minor Start date: Jul 18, 2025 to Jul 21, 2025v92
  6. Minor Start date: Jul 17, 2025 to Jul 18, 2025v91
  7. Minor Start date: Jul 16, 2025 to Jul 17, 2025v90
  8. Minor Start date: Jul 15, 2025 to Jul 16, 2025v89
  9. Minor Start date: Jul 14, 2025 to Jul 15, 2025v88
  10. Minor Start date: Jul 13, 2025 to Jul 14, 2025v87
  11. Minor Start date: Jul 9, 2025 to Jul 13, 2025v86
  12. Minor Start date: Jul 8, 2025 to Jul 9, 2025v85
  13. Minor Start date: Jul 7, 2025 to Jul 8, 2025v84
  14. Minor Start date: Jul 6, 2025 to Jul 7, 2025v83
  15. Minor Start date: Jul 3, 2025 to Jul 6, 2025v82
  16. Minor Start date: Jul 2, 2025 to Jul 3, 2025v81
  17. Minor Start date: Jul 1, 2025 to Jul 2, 2025v80
  18. Minor Start date: Jun 30, 2025 to Jul 1, 2025v79
  19. Minor Start date: Jun 29, 2025 to Jun 30, 2025v78
  20. Minor Start date: Jun 26, 2025 to Jun 29, 2025v77
  21. Minor Start date: Jun 24, 2025 to Jun 26, 2025v76
  22. Minor Start date: Jun 23, 2025 to Jun 24, 2025v75
  23. Minor Start date: Jun 20, 2025 to Jun 23, 2025v74
  24. Minor Start date: Jun 19, 2025 to Jun 20, 2025v73
  25. Minor Start date: Jun 18, 2025 to Jun 19, 2025v72
  26. Minor Start date: Jun 17, 2025 to Jun 18, 2025v71
  27. Minor Start date: Jun 16, 2025 to Jun 17, 2025v70
  28. Minor Start date: Jun 15, 2025 to Jun 16, 2025v69
  29. Minor Start date: Jun 12, 2025 to Jun 15, 2025v68
  30. Minor Start date: Jun 11, 2025 to Jun 12, 2025v67
  31. Minor Start date: Jun 10, 2025 to Jun 11, 2025v66
  32. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jun 9, 2025 to Jun 10, 2025
    v65
  33. Minor Start date: Jun 8, 2025 to Jun 9, 2025v64
  34. Minor Start 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.
Trial Details
NCT Number NCT06851754
Lead Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)
Premature Ovarian Insufficiency
Related terms Primary Ovarian Insufficiency
Enrollment 185 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov