deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT00001521

Three Drug Combination Therapy Versus Conventional Treatment of Children With Congenital Adrenal Hyperplasia

An Open, Randomized, Long-Term Clinical Trial of Flutamide, Testolactone, and Reduced Hydrocortisone Dose vs. Conventional Treatment of Children With Congenital Adrenal Hyperplasia

Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Conditions Congenital Adrenal Hyperplasia (CAH)
Interventions Fludrocortisone Flutamide Hydrocortisone Letrozole Testolactone
Updated 66 times since 2017 Last updated: May 28, 2025 Started: Jun 8, 1995 Primary completion: Apr 1, 2024 Completion: Apr 1, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Congenital Adrenal Hyperplasia (CAH) and is currently completed. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) leads this study, which shows 66 recorded versions since 1995 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Oct 2018 · 30 days · monthly snapshot~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~Jan 2019 · 2 months · monthly snapshot~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~May 2019 · 2 months · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Oct 2019 · 2 months · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jun 2020 · 31 days · monthly snapshot~Jun 2020 – ~Jul 2020 · 30 days · monthly snapshot~Jul 2020 – ~Aug 2020 · 31 days · monthly snapshot~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Oct 2020 · 30 days · monthly snapshot~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Nov 2021 · 31 days · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Jan 2022 · 31 days · monthly snapshot~Jan 2022 – ~Apr 2022 · 3 months · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~Apr 2023 · 31 days · monthly snapshot~Apr 2023 – ~May 2023 · 30 days · monthly snapshot~May 2023 – ~Jun 2023 · 31 days · monthly snapshot~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshot~Jul 2023 – ~Aug 2023 · 31 days · monthly snapshot~Aug 2023 – ~Sep 2023 · 31 days · monthly snapshot~Sep 2023 – ~Oct 2023 · 30 days · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Dec 2023 · 30 days · monthly snapshot~Dec 2023 – ~Feb 2024 · 2 months · monthly snapshot~Feb 2024 – ~Mar 2024 · 29 days · monthly snapshot~Mar 2024 – ~Apr 2024 · 31 days · monthly snapshot~Apr 2024 – ~May 2024 · 30 days · monthly snapshot~May 2024 – ~Jun 2024 · 31 days · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jul 2025 · 10 months · monthly snapshot~Jul 2025 – present · 14 months · monthly snapshot

Change History

66 versions recorded

  1. Jul 2025 — Present [monthly]

    Completed PHASE3

    Phase: PHASE4 → PHASE3

  2. Sep 2024 — Jul 2025 [monthly]

    Completed PHASE4

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  4. Jun 2024 — Jul 2024 [monthly]

    Completed PHASE4

    Status: Active Not Recruiting → Completed

  5. May 2024 — Jun 2024 [monthly]

    Active Not Recruiting PHASE4

▶ Show 61 earlier versions

  1. Apr 2024 — May 2024 [monthly]

    Active Not Recruiting PHASE4

  2. Mar 2024 — Apr 2024 [monthly]

    Active Not Recruiting PHASE4

  3. Feb 2024 — Mar 2024 [monthly]

    Active Not Recruiting PHASE4

  4. Dec 2023 — Feb 2024 [monthly]

    Active Not Recruiting PHASE4

  5. Nov 2023 — Dec 2023 [monthly]

    Active Not Recruiting PHASE4

  6. Oct 2023 — Nov 2023 [monthly]

    Active Not Recruiting PHASE4

  7. Sep 2023 — Oct 2023 [monthly]

    Active Not Recruiting PHASE4

  8. Aug 2023 — Sep 2023 [monthly]

    Active Not Recruiting PHASE4

  9. Jul 2023 — Aug 2023 [monthly]

    Active Not Recruiting PHASE4

    Phase: PHASE2 → PHASE4

  10. Jun 2023 — Jul 2023 [monthly]

    Active Not Recruiting PHASE2

  11. May 2023 — Jun 2023 [monthly]

    Active Not Recruiting PHASE2

  12. Apr 2023 — May 2023 [monthly]

    Active Not Recruiting PHASE2

  13. Mar 2023 — Apr 2023 [monthly]

    Active Not Recruiting PHASE2

  14. Feb 2023 — Mar 2023 [monthly]

    Active Not Recruiting PHASE2

  15. Jan 2023 — Feb 2023 [monthly]

    Active Not Recruiting PHASE2

  16. Dec 2022 — Jan 2023 [monthly]

    Active Not Recruiting PHASE2

  17. Nov 2022 — Dec 2022 [monthly]

    Active Not Recruiting PHASE2

  18. Sep 2022 — Nov 2022 [monthly]

    Active Not Recruiting PHASE2

  19. Jul 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE2

  20. Jun 2022 — Jul 2022 [monthly]

    Active Not Recruiting PHASE2

  21. May 2022 — Jun 2022 [monthly]

    Active Not Recruiting PHASE2

  22. Apr 2022 — May 2022 [monthly]

    Active Not Recruiting PHASE2

  23. Jan 2022 — Apr 2022 [monthly]

    Active Not Recruiting PHASE2

  24. Dec 2021 — Jan 2022 [monthly]

    Active Not Recruiting PHASE2

  25. Nov 2021 — Dec 2021 [monthly]

    Active Not Recruiting PHASE2

  26. Oct 2021 — Nov 2021 [monthly]

    Active Not Recruiting PHASE2

  27. Sep 2021 — Oct 2021 [monthly]

    Active Not Recruiting PHASE2

  28. Jun 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE2

  29. May 2021 — Jun 2021 [monthly]

    Active Not Recruiting PHASE2

  30. Apr 2021 — May 2021 [monthly]

    Active Not Recruiting PHASE2

  31. Mar 2021 — Apr 2021 [monthly]

    Active Not Recruiting PHASE2

  32. Jan 2021 — Mar 2021 [monthly]

    Active Not Recruiting PHASE2

  33. Nov 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE2

  34. Oct 2020 — Nov 2020 [monthly]

    Active Not Recruiting PHASE2

  35. Sep 2020 — Oct 2020 [monthly]

    Active Not Recruiting PHASE2

  36. Aug 2020 — Sep 2020 [monthly]

    Active Not Recruiting PHASE2

  37. Jul 2020 — Aug 2020 [monthly]

    Active Not Recruiting PHASE2

  38. Jun 2020 — Jul 2020 [monthly]

    Active Not Recruiting PHASE2

  39. May 2020 — Jun 2020 [monthly]

    Active Not Recruiting PHASE2

  40. Apr 2020 — May 2020 [monthly]

    Active Not Recruiting PHASE2

  41. Mar 2020 — Apr 2020 [monthly]

    Active Not Recruiting PHASE2

  42. Feb 2020 — Mar 2020 [monthly]

    Active Not Recruiting PHASE2

  43. Jan 2020 — Feb 2020 [monthly]

    Active Not Recruiting PHASE2

  44. Dec 2019 — Jan 2020 [monthly]

    Active Not Recruiting PHASE2

  45. Nov 2019 — Dec 2019 [monthly]

    Active Not Recruiting PHASE2

  46. Oct 2019 — Nov 2019 [monthly]

    Active Not Recruiting PHASE2

  47. Aug 2019 — Oct 2019 [monthly]

    Active Not Recruiting PHASE2

  48. Jul 2019 — Aug 2019 [monthly]

    Active Not Recruiting PHASE2

  49. Jun 2019 — Jul 2019 [monthly]

    Active Not Recruiting PHASE2

  50. May 2019 — Jun 2019 [monthly]

    Active Not Recruiting PHASE2

    Status: Completed → Active Not Recruiting

  51. Mar 2019 — May 2019 [monthly]

    Completed PHASE2

  52. Feb 2019 — Mar 2019 [monthly]

    Completed PHASE2

  53. Jan 2019 — Feb 2019 [monthly]

    Completed PHASE2

    Phase: PHASE1 → PHASE2

  54. Nov 2018 — Jan 2019 [monthly]

    Completed PHASE1

  55. Oct 2018 — Nov 2018 [monthly]

    Completed PHASE1

  56. Sep 2018 — Oct 2018 [monthly]

    Completed PHASE1

  57. Aug 2018 — Sep 2018 [monthly]

    Completed PHASE1

  58. Jul 2018 — Aug 2018 [monthly]

    Completed PHASE1

  59. Jun 2018 — Jul 2018 [monthly]

    Completed PHASE1

  60. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE1

    Status: Active Not Recruiting → Completed

  61. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE1

    First recorded

Jun 1995

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Data source: National Institutes of Health Clinical Center (CC)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations