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NCT01127659 · ClinicalTrials.gov registry record · Phase 4

Testosterone Replacement in Men With Diabetes and Obesity

A Phase 4 study, sponsored by University at Buffalo.

Completed
Registry status
Phase 4
Development phase
137
Enrollment target

NCT01127659: Completed Phase 4 study, sponsored by University at Buffalo.

NCT01127659 is a Phase 4 study that has completed, run by University at Buffalo. The registered enrollment target is 137 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01127659, a Phase 4 study, has completed, sponsored by University at Buffalo.

COMPLETED
Registry status
Phase 4
Development phase
137 participants
Enrollment target

Study Summary

The purpose of this study is to examine the effect of having testosterone deficiency in men with diabetes and with obesity. The study will also evaluate the effect of testosterone therapy. This will be done by comparing the changes in several body response indicators following treatment with testosterone in diabetic or obese-non diabetic men with low testosterone levels and comparing them to diabetic or obese-non diabetic men with low testosterone who are not treated with testosterone.

Primary Outcome

measured by HE clamps (baseline and 6 mths)

Interventions

  • DRUG placebo
  • DRUG testosterone

Trial Details

FieldValue
Enrollment Target 137 participants
Start Date 2010-05
Est. Completion 2015-11
Phase Phase 4
University at Buffalo

67 total trials

What the finished NCT01127659 record still lists

NCT01127659 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (74% lower).

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT01127659 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01127659 about?

NCT01127659 is a clinical study titled "Testosterone Replacement in Men With Diabetes and Obesity". The purpose of this study is to examine the effect of having testosterone deficiency in men with diabetes and with obesity. The study will also evaluate the effect of testosterone therapy. This will be done by comparing the changes in several body response indicators following treatment with testost...

What is the current status of trial NCT01127659?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 137 participants. The study started on 2010-05. Estimated completion is 2015-11.

What interventions are being tested in trial NCT01127659?

The interventions under investigation include: placebo (DRUG), testosterone (DRUG).

Who is sponsoring clinical trial NCT01127659?

This trial is sponsored by University at Buffalo, which has 67 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01127659's enrollment target sits among peer trials

137 594th of 2000 higher than 1,405 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT01127659, the US trial registry maintained by the National Library of Medicine. NCT01127659 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.