deltatrials
Completed PHASE4 INTERVENTIONAL 2-arm NCT00752869

Efficacy Study for Use of Dutasteride (Avodart) With Testosterone Replacement (DUT/T)

Dutasteride in Men Receiving Testosterone Therapy: Impact on Serum PSA, Testosterone, DHT Levels and Prostate Volume: Implications for Prostate Safety

Sponsor: GlaxoSmithKline

Conditions Hypogonadism
Interventions dutasteride placebo
Updated 6 times since 2017 Last updated: Feb 25, 2013 Started: Sep 30, 2008 Primary completion: Mar 31, 2012 Completion: Mar 31, 2012
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE4 clinical study on Hypogonadism, this trial is completed. The trial is conducted by GlaxoSmithKline and has accumulated 6 data snapshots since 2008. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

Termination criteria 1. Serum AST or ALT \> 3 times ULN 2. Total serum bilirubin \> 1.5 times ULN * no study termination of a patient with documented Gilberts disease for an isolated bilirubin elevation unless it exceeds 2.5x the upper limit of normal. 3. Hematocrit \> 55% 4. Subject experiences any unacceptable or intolerable adverse effect. 5. Subject is non-compliant with the study protocol. 6. Subject needs to take any medication that would interfere with study measurements 7. Subject develops prostate or breast cancer

Termination criteria

1. Serum AST or ALT \> 3 times ULN 2. Total serum bilirubin \> 1.5 times ULN

* no study termination of a patient with documented Gilberts disease for an isolated bilirubin elevation unless it exceeds 2.5x the upper limit of normal. 3. Hematocrit \> 55% 4. Subject experiences any unacceptable or intolerable adverse effect. 5. Subject is non-compliant with the study protocol. 6. Subject needs to take any medication that would interfere with study measurements 7. Subject develops prostate or breast cancer

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

6 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE4

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE4

  4. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE4

  5. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE4

▶ Show 1 earlier version

  1. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE4

    First recorded

Sep 2008

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • GlaxoSmithKline
  • The Miriam Hospital
Data source: The Miriam Hospital

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

Study Locations