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COMPLETED Phase 2

Pharmacokinetic Study to Determine Time to Steady-state

NCT00911586 · View on ClinicalTrials.gov ↗

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.

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

Sponsor

Clarus Therapeutics

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00911586

The ClinicalTrials.gov registry entry for NCT00911586 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Clarus Therapeutics, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00911586 reports 1 study location spanning 1 distinct geographic area — top geographies include Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00911586?

The interventions under investigation include: Testosterone undecanoate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00911586?

This trial is sponsored by Clarus Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial