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NCT01228071 · ClinicalTrials.gov registry record · Phase 3

Time to Eugonadal Range, Time to Steady State and Drying Time

A Phase 3 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.

Completed
Registry status
Phase 3
Development phase
34
Enrollment target

NCT01228071: Completed Phase 3 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.

NCT01228071 is a Phase 3 study that has completed, run by Endo USA Inc., a Keenova Therapeutics Company. The registered enrollment target is 34 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01228071, a Phase 3 study, has completed, sponsored by Endo USA Inc., a Keenova Therapeutics Company.

COMPLETED
Registry status
Phase 3
Development phase
34 participants
Enrollment target

Study Summary

This is a multicenter, open-label, single arm trial to evaluate the time to eugonadal testosterone range after initial testosterone gel 2% application, time to steady state after after initiation of testosterone gel 2%, and drying time after application of testosterone gel 2%.

Primary Outcome

The time to eugonadal range (ie, testosterone ≥300 ng/dL) was assessed based on the 24-hour PK serum concentration data.

Interventions

  • DRUG testosterone gel 2%

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2010-11
Est. Completion 2011-05
Phase Phase 3

What the finished NCT01228071 record still lists

NCT01228071 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 1 intervention - of which testosterone gel 2% is the first listed.

NCT01228071 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01228071 about?

NCT01228071 is a clinical study titled "Time to Eugonadal Range, Time to Steady State and Drying Time". This is a multicenter, open-label, single arm trial to evaluate the time to eugonadal testosterone range after initial testosterone gel 2% application, time to steady state after after initiation of testosterone gel 2%, and drying time after application of testosterone gel 2%.

What is the current status of trial NCT01228071?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 34 participants. The study started on 2010-11. Estimated completion is 2011-05.

What interventions are being tested in trial NCT01228071?

The interventions under investigation include: testosterone gel 2% (DRUG).

Who is sponsoring clinical trial NCT01228071?

This trial is sponsored by Endo USA Inc., a Keenova Therapeutics Company, which has 61 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01228071's enrollment target sits among peer trials

34 1905th of 2000 higher than 94 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT01228071, the US trial registry maintained by the National Library of Medicine. NCT01228071 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.