CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 92 enrolled
Drug / intervention
Testosterone gel 1.62% +1 moredrug
Likely dose
Not stated in 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/NCT03887936
NCT03887936Phase 4Completed

Testosterone Therapy and Bone Quality in Men With Diabetes and Hypogonadism

VA Office of Research and Development·interventional·Posted Mar 25, 2019·Updated Apr 29, 2026

In Brief

A Phase 4 clinical trial evaluating Testosterone gel 1.62% and Placebo for Type 2 Diabetes Mellitus and Hypogonadism. Completed, enrolled 92 participants across 1 site.

Detailed Summary

Low testosterone and diabetes mellitus are each associated with increased risk for fractures. Men with diabetes mellitus are commonly found to have low testosterone as well. Testosterone has been shown to improve the bone health of patients with low testosterone but has not been tested in patients who also have diabetes mellitus in addition to low testosterone. To date, there is no treatment that is specifically recommended for bone disease among patients with diabetes. This study will evaluate the effect of testosterone on the bone health of male Veterans who have both diabetes and low testosterone, both of which are highly prevalent in this subset of the population.

Study Details

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

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedMar 25, 2019
Enrollment StartOct 1, 2019
Primary CompletionOct 8, 2025
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 7.3 years ago

Interventions

Testosterone gel 1.62%drug

Testosterone gel 1.62%, apply 2 pumps to upper arm and shoulder.

Placebodrug

Matching placebo gel, apply 2 pumps to upper arm and shoulder