deltatrials
Completed PHASE1 INTERVENTIONAL 7-arm NCT00001259

A Treatment Study for Premenstrual Syndrome (PMS)

The Treatment of Menstrually-Related Mood Disorders With the Gonadotropin Releasing Hormone (GnRH) Agonist, Depot Leuprolide Acetate (Lupron)

Sponsor: National Institute of Mental Health (NIMH)

Conditions Menstruation Disturbances Premenstrual Syndrome
Interventions Estradiol Patches Leuprolide Placebo injection Placebo patch Placebo suppository Progesterone
Updated 30 times since 2017 Last updated: Feb 28, 2023 Started: Aug 11, 1992 Primary completion: Feb 6, 2020 Completion: Feb 6, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00001259, this PHASE1 trial focuses on Menstruation Disturbances and Premenstrual Syndrome and remains completed. Sponsored by National Institute of Mental Health (NIMH), it has been updated 30 times since 1992, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Apr 2018 · 14 months · monthly snapshot~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Mar 2019 · 7 months · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · 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 – ~Feb 2020 · 2 months · 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 – ~Jul 2020 · 2 months · monthly snapshot~Jul 2020 – ~Nov 2020 · 4 months · monthly snapshot~Nov 2020 – ~Dec 2020 · 30 days · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Apr 2021 · 59 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Apr 2023 · 23 months · monthly snapshot~Apr 2023 – ~Jul 2024 · 15 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 19 months · monthly snapshot~Jan 2026 – present · 3 months · monthly snapshot

Change History

30 versions recorded

  1. Jan 2026 — Present [monthly]

    Completed PHASE1

  2. Sep 2024 — Present [monthly]

    Completed PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  4. Apr 2023 — Jul 2024 [monthly]

    Completed PHASE1

  5. May 2021 — Apr 2023 [monthly]

    Completed PHASE1

▶ Show 25 earlier versions

  1. Apr 2021 — May 2021 [monthly]

    Completed PHASE1

  2. Feb 2021 — Apr 2021 [monthly]

    Completed PHASE1

  3. Jan 2021 — Feb 2021 [monthly]

    Completed PHASE1

  4. Dec 2020 — Jan 2021 [monthly]

    Completed PHASE1

  5. Nov 2020 — Dec 2020 [monthly]

    Completed PHASE1

  6. Jul 2020 — Nov 2020 [monthly]

    Completed PHASE1

  7. May 2020 — Jul 2020 [monthly]

    Completed PHASE1

  8. Apr 2020 — May 2020 [monthly]

    Completed PHASE1

  9. Mar 2020 — Apr 2020 [monthly]

    Completed PHASE1

    Status: Recruiting → Completed · Phase: None → PHASE1

  10. Feb 2020 — Mar 2020 [monthly]

    Recruiting

  11. Dec 2019 — Feb 2020 [monthly]

    Recruiting

  12. Nov 2019 — Dec 2019 [monthly]

    Recruiting

  13. Oct 2019 — Nov 2019 [monthly]

    Recruiting

  14. Aug 2019 — Oct 2019 [monthly]

    Recruiting

  15. Jul 2019 — Aug 2019 [monthly]

    Recruiting

  16. Jun 2019 — Jul 2019 [monthly]

    Recruiting

  17. May 2019 — Jun 2019 [monthly]

    Recruiting

  18. Apr 2019 — May 2019 [monthly]

    Recruiting

  19. Mar 2019 — Apr 2019 [monthly]

    Recruiting

  20. Aug 2018 — Mar 2019 [monthly]

    Recruiting

  21. Jul 2018 — Aug 2018 [monthly]

    Recruiting

  22. Jun 2018 — Jul 2018 [monthly]

    Recruiting

  23. Apr 2018 — Jun 2018 [monthly]

    Recruiting

    Phase: NA → None

  24. Feb 2017 — Apr 2018 [monthly]

    Recruiting NA

  25. Jan 2017 — Feb 2017 [monthly]

    Recruiting NA

    First recorded

Aug 1992

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Institute of Mental Health (NIMH)
Data source: National Institutes of Health Clinical Center (CC)

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

Study Locations