deltatrials
Completed PHASE1 INTERVENTIONAL 3-arm NCT03745144

Effects of Cladribine Tablets on the PK of Microgynon®

A Randomized, Double-blind, 2-Period, 2-Sequence Crossover Phase I Study With a 1 Month run-in Period to Examine the Effect of Cladribine Tablets on the PK of a Monophasic Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel (Microgynon®) in Pre-Menopausal Women With RMS

Sponsor: Merck KGaA, Darmstadt, Germany

Conditions Relapsing Multiple Sclerosis (RMS)
Interventions Cladribine Microgynon® Placebo
Updated 32 times since 2018 Last updated: Aug 25, 2023 Started: Jan 17, 2019 Primary completion: Sep 2, 2022 Completion: Sep 16, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on Relapsing Multiple Sclerosis (RMS), this trial is completed. The trial is conducted by Merck KGaA, Darmstadt, Germany and has accumulated 32 data snapshots since 2019. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshot~Jan 2019 – ~Apr 2019 · 3 months · monthly snapshot~Apr 2019 – ~Jul 2019 · 3 months · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Nov 2019 · 2 months · 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 – ~Oct 2020 · 5 months · monthly snapshot~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~Jun 2021 · 2 months · 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 – ~Feb 2022 · 31 days · monthly snapshot~Feb 2022 – ~Mar 2022 · 28 days · monthly snapshot~Mar 2022 – ~Nov 2022 · 8 months · monthly snapshot~Nov 2022 – ~Apr 2024 · 17 months · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

32 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE1

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  4. Apr 2024 — Jul 2024 [monthly]

    Completed PHASE1

  5. Nov 2022 — Apr 2024 [monthly]

    Completed PHASE1

    Status: Active Not Recruiting → Completed

▶ Show 27 earlier versions

  1. Mar 2022 — Nov 2022 [monthly]

    Active Not Recruiting PHASE1

    Status: Recruiting → Active Not Recruiting

  2. Feb 2022 — Mar 2022 [monthly]

    Recruiting PHASE1

  3. Jan 2022 — Feb 2022 [monthly]

    Recruiting PHASE1

  4. Dec 2021 — Jan 2022 [monthly]

    Recruiting PHASE1

  5. Nov 2021 — Dec 2021 [monthly]

    Recruiting PHASE1

  6. Oct 2021 — Nov 2021 [monthly]

    Recruiting PHASE1

  7. Sep 2021 — Oct 2021 [monthly]

    Recruiting PHASE1

  8. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE1

  9. Apr 2021 — Jun 2021 [monthly]

    Recruiting PHASE1

  10. Mar 2021 — Apr 2021 [monthly]

    Recruiting PHASE1

  11. Feb 2021 — Mar 2021 [monthly]

    Recruiting PHASE1

  12. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE1

  13. Nov 2020 — Jan 2021 [monthly]

    Recruiting PHASE1

  14. Oct 2020 — Nov 2020 [monthly]

    Recruiting PHASE1

    Status: Active Not Recruiting → Recruiting

  15. May 2020 — Oct 2020 [monthly]

    Active Not Recruiting PHASE1

    Status: Recruiting → Active Not Recruiting

  16. Apr 2020 — May 2020 [monthly]

    Recruiting PHASE1

  17. Mar 2020 — Apr 2020 [monthly]

    Recruiting PHASE1

  18. Feb 2020 — Mar 2020 [monthly]

    Recruiting PHASE1

  19. Jan 2020 — Feb 2020 [monthly]

    Recruiting PHASE1

  20. Dec 2019 — Jan 2020 [monthly]

    Recruiting PHASE1

  21. Nov 2019 — Dec 2019 [monthly]

    Recruiting PHASE1

  22. Sep 2019 — Nov 2019 [monthly]

    Recruiting PHASE1

  23. Aug 2019 — Sep 2019 [monthly]

    Recruiting PHASE1

  24. Jul 2019 — Aug 2019 [monthly]

    Recruiting PHASE1

  25. Apr 2019 — Jul 2019 [monthly]

    Recruiting PHASE1

    Status: Not Yet Recruiting → Recruiting

  26. Jan 2019 — Apr 2019 [monthly]

    Not Yet Recruiting PHASE1

  27. Dec 2018 — Jan 2019 [monthly]

    Not Yet Recruiting PHASE1

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Merck KGaA, Darmstadt, Germany
Data source: Merck KGaA, Darmstadt, Germany

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

Study Locations