deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT03198728

Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men

A 12-Month, Randomized, Active-controlled, Open-label Study of the Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men (RE-TUne)

Sponsor: Marius Pharmaceuticals

Conditions Hypogonadism, Male
Interventions AndroGel SOV2012-F1
Updated 18 times since 2017 Last updated: Jun 6, 2023 Started: Jul 5, 2017 Primary completion: May 1, 2020 Completion: May 1, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03198728, this PHASE3 trial focuses on Hypogonadism, Male and remains completed. Sponsored by Marius Pharmaceuticals, it has been updated 18 times since 2017, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jul 2017 – ~Aug 2017 · 31 days · monthly snapshot~Aug 2017 – ~Sep 2017 · 31 days · monthly snapshot~Sep 2017 – ~Jan 2018 · 4 months · monthly snapshot~Jan 2018 – ~Jun 2018 · 5 months · monthly snapshot~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshot~Sep 2018 – ~Dec 2018 · 3 months · monthly snapshot~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshot~Jan 2019 – ~Jul 2019 · 6 months · monthly snapshot~Jul 2019 – ~Apr 2020 · 9 months · monthly snapshot~Apr 2020 – ~Aug 2020 · 4 months · monthly snapshot~Aug 2020 – ~Jan 2021 · 5 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Apr 2022 · 14 months · monthly snapshot~Apr 2022 – ~Jul 2023 · 15 months · monthly snapshot~Jul 2023 – ~Jul 2024 · 12 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

18 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Jul 2023 — Jul 2024 [monthly]

    Completed PHASE3

  5. Apr 2022 — Jul 2023 [monthly]

    Completed PHASE3

▶ Show 13 earlier versions

  1. Feb 2021 — Apr 2022 [monthly]

    Completed PHASE3

  2. Jan 2021 — Feb 2021 [monthly]

    Completed PHASE3

  3. Aug 2020 — Jan 2021 [monthly]

    Completed PHASE3

    Status: Recruiting → Completed

  4. Apr 2020 — Aug 2020 [monthly]

    Recruiting PHASE3

  5. Jul 2019 — Apr 2020 [monthly]

    Recruiting PHASE3

  6. Jan 2019 — Jul 2019 [monthly]

    Recruiting PHASE3

  7. Dec 2018 — Jan 2019 [monthly]

    Recruiting PHASE3

    Status: Active Not Recruiting → Recruiting

  8. Sep 2018 — Dec 2018 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  9. Jun 2018 — Sep 2018 [monthly]

    Recruiting PHASE3

  10. Jan 2018 — Jun 2018 [monthly]

    Recruiting PHASE3

  11. Sep 2017 — Jan 2018 [monthly]

    Recruiting PHASE3

  12. Aug 2017 — Sep 2017 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  13. Jul 2017 — Aug 2017 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Marius Pharmaceuticals
  • Syneos Health
Data source: Marius Pharmaceuticals

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

Study Locations

Atlanta, United States , Aventura, United States , Bala-Cynwyd, United States , Birmingham, United States , Boise, United States , Brandon, United States , Chattanooga, United States , Chestnut Hill, United States , Clearwater, United States , Columbus, United States and 24 more locations