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NCT00924612 · ClinicalTrials.gov registry record · Phase 2

Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation

A Phase 2 study, sponsored by Clarus Therapeutics.

Completed
Registry status
Phase 2
Development phase
16
Enrollment target

NCT00924612: Completed Phase 2 study, sponsored by Clarus Therapeutics.

NCT00924612 is a Phase 2 study that has completed, run by Clarus Therapeutics. The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00924612, a Phase 2 study, has completed, sponsored by Clarus Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
16 participants
Enrollment target

Study Summary

The purpose of the study is to determine the effect of food with various amounts of fat on the absorption of an oral testosterone undecanoate formulation.

Primary Outcome

PK population where subjects are randomly assigned to one of four dietary sequences of five fat regimens. Active drug is identical for all subjects and all diets. Effect of normal dietary fat is compared to fasting, very low fat, low fat, and high fat diets for mean T Cavg25.

Interventions

  • DRUG Oral testosterone undecanoate (containing 300 mg T)

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2009-07
Est. Completion 2010-07
Phase Phase 2
Clarus Therapeutics

11 total trials

What the finished NCT00924612 record still lists

NCT00924612 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).

The record links to 0 conditions, and to 1 intervention - of which Oral testosterone undecanoate (containing 300 mg T) is the first listed.

NCT00924612 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00924612 about?

NCT00924612 is a clinical study titled "Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation". The purpose of the study is to determine the effect of food with various amounts of fat on the absorption of an oral testosterone undecanoate formulation.

What is the current status of trial NCT00924612?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2009-07. Estimated completion is 2010-07.

What interventions are being tested in trial NCT00924612?

The interventions under investigation include: Oral testosterone undecanoate (containing 300 mg T) (DRUG).

Who is sponsoring clinical trial NCT00924612?

This trial is sponsored by Clarus Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00924612's enrollment target sits among peer trials

16 1908th of 2000 higher than 82 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00924612, the US trial registry maintained by the National Library of Medicine. NCT00924612 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.