At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 155 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.
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
In Brief
A Phase 3 clinical trial evaluating Testosterone MD-Lotion for Hypogonadism. Completed, enrolled 155 participants across 27 sites in 6 countries.
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 (cutaneous solution), and this study will evaluate the efficacy via pharmacokinetics of various doses of this product. The study will also assess safety of the product.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypogonadism
CountriesAustralia, France, Germany, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2008
First PostedJun 2008
Primary CompletionJul 2009
TodayJul 2026
First PostedJun 20, 2008
Enrollment StartJun 1, 2008
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 18.0 years ago
Interventions
Testosterone MD-Lotiondrug
30 mg to 120 mg administered topically once daily for 120 days