At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 102 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Androxal 12.5 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 Study to Evaluate the Efficacy of Androxal® in Improving Glycemic Control in Men With Secondary Hypogonadism or Adult-onset Idiopathic Hypogonadotropic Hypogonadism (AIHH) and Type 2 Diabetes Mellitus With Sub-Optimum Treatment
In Brief
A Phase 2 clinical trial evaluating Placebo and Androxal for Type 2 Diabetes Mellitus and Secondary Hypogonadism. Completed, enrolled 102 participants across 18 sites.
Detailed Summary
The purpose of this study is to determine the effect the investigative drug has on glycemic control in men with type 2 diabetes mellitus (T2DM) and secondary hypogonadism
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus, Secondary Hypogonadism
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2010
Enrollment StartOct 2010
Primary CompletionDec 2011
TodayJul 2026
First PostedAug 30, 2010
Enrollment StartOct 1, 2010
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 15.8 years ago
Interventions
Placebodrug
Placebo capsule 1x daily for 3 months
Androxaldrug
Capsules 12.5 mg or 25 mg 1x daily for 3 months