At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 53 enrolled
Drug / intervention
Acyline +4 moredrug
Likely dose
Acyline 300 mcgfrom 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.
Androgen-mediated Pathways in the Regulation of Insulin Sensitivity in Men
In Brief
A Phase 2 clinical trial evaluating Acyline, Testosterone 1.62% gel, and 3 other interventions for Insulin Resistance and 4 related conditions. Completed, enrolled 53 participants across 1 site.
Detailed Summary
The purpose of this research study is to understand the effects of testosterone and estrogen on the body's response to the hormone insulin.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsulin Resistance, Type 2 Diabetes Mellitus, Obesity, Androgen Deficiency, Metabolic Disease
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 2012
Enrollment StartJun 2013
Primary CompletionMay 2015
Study CompletionDec 2017
TodayJul 2026
First PostedSep 18, 2012
Enrollment StartJun 1, 2013
Primary CompletionMay 1, 2015
Study CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 13.8 years ago
Interventions
Acylinedrug
300 mcg/mL administered subcutaneously (at Day 0, Week 2)
Testosterone 1.62% geldrug
Transdermal Testosterone Gel (either 1.25g or 5g/d) for 4 weeks
Letrozoledrug
Letrozole oral aromatase inhibitor 5mg daily for 4 weeks
Placebo gel (for Testosterone 1.62% gel)drug
placebo gel manufactured to mimic Testosterone 1.62% gel
Placebo pill (for Letrozole)drug
Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d