At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 82 enrolled
Drug / intervention
Testosterone +1 moredrug
Likely dose
Testosterone 50 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.
Testosterone Replacement in Metabolic Syndrome and Inflammation of Fat Tissue
In Brief
A Phase 4 clinical trial evaluating Testosterone and Placebo for Hypogonadism and 3 related conditions. Completed, enrolled 82 participants across 2 sites.
Detailed Summary
Hypogonadism (HG) frequently complicates the Metabolic Syndrome (MetS), whether testosterone replacement (TRT) is beneficial has not been clearly ascertained. This study was designed to address the effects of TRT on insulin resistance, body composition and pro-inflammatory status in naïve patients with MetS and HG.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypogonadism, Metabolic Syndrome, Obesity, Erectile Dysfunction
CountriesItaly
Collaborators--
Timeline
Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2004
First PostedMay 2010
Primary CompletionOct 2014
TodayJul 2026
First PostedMay 14, 2010
Enrollment StartJan 1, 2004
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10.8 yearsPosted 16.1 years ago
Interventions
Testosteronedrug
Testosterone transdermal gel 50 mg/day (5 gr)
Placebodrug
Placebo transdermal gel (5 gr)