deltatrials
Completed PHASE3 NCT01446042

Safety and Efficacy of Intranasal TBS-1 Treatment of Male Hypogonadism

A 90-Day, Randomized, Dose-Ranging Study, Including Potential Dose Titration, Evaluating the Efficacy and Safety of Intranasal TBS-1 in the Treatment of Male Hypogonadism With Sequential Safety Extension Periods of 90 and 180 Days

Sponsor: Acerus Pharmaceuticals Corporation

Interventions Testosterone
Updated 9 times since 2017 Last updated: May 15, 2018 Started: Sep 30, 2011 Primary completion: Dec 31, 2012 Completion: Mar 31, 2013

This PHASE3 trial investigates Male Hypogonadism and is currently completed. Acerus Pharmaceuticals Corporation leads this study, which shows 9 recorded versions since 2011 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotUnknown Status~Feb 2017 – ~Feb 2018 · 12 months · monthly snapshotUnknown Status~Feb 2018 – ~Jun 2018 · 4 months · monthly snapshotUnknown Status~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshotUnknown Status~Jul 2018 – ~Jan 2021 · 30 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted

Change History

9 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. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

  5. Jul 2018 — Jan 2021 [monthly]

    Completed PHASE3

    Status: Unknown StatusCompleted

Show 4 earlier versions
  1. Jun 2018 — Jul 2018 [monthly]

    Unknown Status PHASE3

  2. Feb 2018 — Jun 2018 [monthly]

    Unknown Status PHASE3

  3. Feb 2017 — Feb 2018 [monthly]

    Unknown Status PHASE3

  4. Jan 2017 — Feb 2017 [monthly]

    Unknown Status PHASE3

    First recorded

Sep 2011

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Acerus Pharmaceuticals Corporation
Data source: Acerus Pharmaceuticals Corporation

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