Methods
Hypogonadism, hypogonadism, anemia
CVD, HYPOGONADISM, HYPOGONADISM, ANEMIA
The TRAVERSE trial’s protocol and eligibility criteria have been published.Study protocol was approved by the national and local institutional review boards for human participants’ research. An independent data and safety monitoring board oversaw the study’s progress and safety data. All participants provided written informed consent. This report follows the Consolidated Standards of Reporting Trials (The analytic sample for the correction of anemia included all randomized participants who had anemia at baseline, defined as hemoglobin level below 12.7 g/dL (to convert to grams per liter, multiply by 10). This threshold was based on established criteria used in previous trials to define anemia.Participants were randomized using an interactive response technology with stratification for preexisting CVD to either 1.62% transdermal testosterone gel (AbbVie, Inc) or matching placebo gel daily until the study’s completion. Participants were started on 40.5 mg of testosterone gel or placebo gel daily and dose was titrated based on serum testosterone and hematocrit levels, using a prespecified dose-titration plan.Complete blood counts and blood chemistries were measured at baseline, months 6 and 12, and then annually for the duration of the study. The Hypogonadism Impact of Symptoms Questionnaire (HIS-Q) with 5 subdomains (sexual, energy, sleep, cognition, and mood), a validated patient-reported measure of symptoms of hypogonadism and response to TRT,