CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 71 enrolled
Drug / intervention
Testosterone MD-Lotiondrug
Likely dose
Testosterone MD-Lotion 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00857454
NCT00857454Phase 3Completed
CompareCT.gov

A Phase III Open-label Extension of the MTE08 Trial (A Phase III Open-label Titration Trial to Evaluate the Effectiveness and Safety of Different Doses of a Dermal Application of Testosterone MD-Lotion® (Cutaneous Solution) in Hypogonadal Men) to Evaluate Skin-safety

Eli Lilly and Company·interventional·Posted Mar 6, 2009·Updated Jan 5, 2011

In Brief

A Phase 3 clinical trial evaluating Testosterone MD-Lotion for Hypogonadism. Completed, enrolled 71 participants across 11 sites.

Detailed Summary

Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study will assess the occurrence of skin safety events for a further two months of continuous use of the Testosterone MD-Lotion® (cutaneous solution) after completion of the MTE08 (NCT00702650) trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypogonadism
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 6, 2009
Enrollment StartOct 1, 2008
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 17.3 years ago

Interventions

Testosterone MD-Lotiondrug

30 mg to 120 mg administered topically once daily for 60 days