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NCT01187485 · ClinicalTrials.gov registry record · Phase 1

A Randomized Study of Testosterone Replacement in Patients With Low Risk Hormone Refractory Prostate Cancer

A Phase 1 study, sponsored by University of Chicago.

Completed
Registry status
Phase 1
Development phase
15
Enrollment target

NCT01187485: Completed Phase 1 study, sponsored by University of Chicago.

NCT01187485 is a Phase 1 study that has completed, run by University of Chicago. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01187485, a Phase 1 study, has completed, sponsored by University of Chicago.

COMPLETED
Registry status
Phase 1
Development phase
15 participants
Enrollment target

Study Summary

The purpose of this study is to see how safe Androderm® (the study drug) is at three different doses in subjects with early hormone refractory prostate cancer. In addition, information about hormonal levels and the effects of testosterone on quality of life including sexual functioning and muscle strength will be collected.

Primary Outcome

To determine the safety of Androderm® 2.5 mg, 5.0 mg, and 7.5 mg in patients with early hormone refractory prostate cancer.

Interventions

  • DRUG Androderm® 2.5mg
  • DRUG Androderm® 5.0mg
  • DRUG Androderm® 7.5mg

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2004-06
Est. Completion 2009-02
Phase Phase 1
University of Chicago

796 total trials

What the finished NCT01187485 record still lists

NCT01187485 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).

The record links to 0 conditions, and to 3 interventions - of which Androderm® 2.5mg is the first listed.

NCT01187485 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01187485 about?

NCT01187485 is a clinical study titled "A Randomized Study of Testosterone Replacement in Patients With Low Risk Hormone Refractory Prostate Cancer". The purpose of this study is to see how safe Androderm® (the study drug) is at three different doses in subjects with early hormone refractory prostate cancer. In addition, information about hormonal levels and the effects of testosterone on quality of life including sexual functioning and muscle st...

What is the current status of trial NCT01187485?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2004-06. Estimated completion is 2009-02.

What interventions are being tested in trial NCT01187485?

The interventions under investigation include: Androderm® 2.5mg (DRUG), Androderm® 5.0mg (DRUG), Androderm® 7.5mg (DRUG).

Who is sponsoring clinical trial NCT01187485?

This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01187485's enrollment target sits among peer trials

15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01187485, the US trial registry maintained by the National Library of Medicine. NCT01187485 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.