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NCT00911586 · ClinicalTrials.gov registry record · Phase 2

Pharmacokinetic Study to Determine Time to Steady-state

A Phase 2 study of Secondary Hypogonadism and Male Hypogonadism, sponsored by Clarus Therapeutics.

Completed
Registry status
Phase 2
Development phase
15
Enrollment target
1
Study location

NCT00911586: Completed Phase 2 study of Secondary Hypogonadism and Male Hypogonadism, sponsored by Clarus Therapeutics.

NCT00911586 is a Phase 2 study of Secondary Hypogonadism and Male Hypogonadism that has completed, run by Clarus Therapeutics. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00911586, a Phase 2 study of Secondary Hypogonadism and Male Hypogonadism, has completed, sponsored by Clarus Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
15 participants
Enrollment target
1
Study location

Study Summary

The purpose of the study is to confirm how long (i.e., how many days) it takes to reach steady-state when testosterone undecanoate is administered twice daily.

Primary Outcome

Serum T at steady state by evaluating the day-to-day changes in pre-dose concentrations on Days 1, 3, 5, 6, and 7 of treatment.

Interventions

  • DRUG Testosterone undecanoate

Study Locations (1)

Alabama

  • Alabama Clinical Therapeutics - Birmingham

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2009-07
Est. Completion 2010-01
Phase Phase 2
Clarus Therapeutics

11 total trials

What the finished NCT00911586 record still lists

NCT00911586 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).

The record links to 3 conditions, with Secondary Hypogonadism appearing as the primary indexed condition, and to 1 intervention - of which Testosterone undecanoate is the first listed.

NCT00911586 reports a single indexed study location in Alabama.

Frequently Asked Questions

What is clinical trial NCT00911586 about?

NCT00911586 is a clinical study titled "Pharmacokinetic Study to Determine Time to Steady-state". The purpose of the study is to confirm how long (i.e., how many days) it takes to reach steady-state when testosterone undecanoate is administered twice daily.

What is the current status of trial NCT00911586?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2009-07. Estimated completion is 2010-01.

What conditions does trial NCT00911586 study?

This clinical trial studies the following conditions: Secondary Hypogonadism, Male Hypogonadism, Primary Hypogonadism.

What interventions are being tested in trial NCT00911586?

The interventions under investigation include: Testosterone undecanoate (DRUG).

Who is sponsoring clinical trial NCT00911586?

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

Where is trial NCT00911586 being conducted?

This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Secondary Hypogonadism

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00911586's enrollment target sits among peer trials

15 1919th of 2000 higher than 60 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 NCT00911586, the US trial registry maintained by the National Library of Medicine. NCT00911586 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.