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NCT00438321 · ClinicalTrials.gov registry record · Phase 1

Effect of Increasing Testosterone on Insulin Sensitivity in Men With the Metabolic Syndrome

A Phase 1 study, sponsored by Massachusetts General Hospital.

Terminated
Registry status
Phase 1
Development phase
66
Enrollment target

NCT00438321: Clinical Trial Phase 1 study, sponsored by Massachusetts General Hospital.

NCT00438321 is a Phase 1 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 66 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00438321, a Phase 1 study, was terminated before completion, sponsored by Massachusetts General Hospital.

TERMINATED
Registry status
Phase 1
Development phase
66 participants
Enrollment target

Study Summary

The purpose of the study is to examine the effect of testosterone treatment on insulin in men with the metabolic syndrome with testosterone levels at or below the lower end of the normal range.

Primary Outcome

Assessed by euglycemic-hyperinsulinemic clamp

Interventions

  • OTHER Placebo
  • DRUG Zoladex
  • DRUG Testosterone gel
  • DRUG Anastrozole Pill

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2006-09
Est. Completion 2010-02-26
Phase Phase 1
Massachusetts General Hospital

2,032 total trials

Why NCT00438321 stopped before completion

NCT00438321 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT00438321 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00438321 about?

NCT00438321 is a clinical study titled "Effect of Increasing Testosterone on Insulin Sensitivity in Men With the Metabolic Syndrome". The purpose of the study is to examine the effect of testosterone treatment on insulin in men with the metabolic syndrome with testosterone levels at or below the lower end of the normal range.

What is the current status of trial NCT00438321?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2006-09. Estimated completion is 2010-02-26.

What interventions are being tested in trial NCT00438321?

The interventions under investigation include: Placebo (OTHER), Zoladex (DRUG), Testosterone gel (DRUG), Anastrozole Pill (DRUG).

Who is sponsoring clinical trial NCT00438321?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00438321's enrollment target sits among peer trials

66 786th of 2000 higher than 1,203 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 NCT00438321, the US trial registry maintained by the National Library of Medicine. NCT00438321 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.