Erratum: Corrections to Participant Numbers in T4DM Testosterone Therapy Study

Overview

This erratum addresses corrections in participant numbers reported in the Results section and Table 1 of the T4DM study analyzing testosterone therapy's impact on male sexual function. The corrected number of participants with at least one IIEF-15 domain measurement is 932, not 931, with corresponding adjustments in data completeness and baseline characteristics.

Background

The T4DM (Testosterone for Diabetes) study investigated the effects of testosterone therapy on male sexual function in men with diabetes. The study randomized 1007 participants to testosterone or placebo groups and assessed sexual function using the IIEF-15 instrument across multiple domains. Accurate reporting of participant numbers and baseline characteristics is critical for interpreting the study's findings and ensuring data integrity.

Data Highlights

Corrected participant numbers in the analysis cohort: 932 (92% of 1007) had at least one IIEF-15 domain measured.
Complete data available for 74% (688/932) of participants.
Randomization: 471 (51%) to testosterone treatment, 461 (49%) to placebo.
Baseline characteristics were well matched between groups, including PDE5 inhibitor use.

Key Findings

• The number of participants included in the sexual function analyses was corrected from 931 to 932.
• Complete data availability was recalculated based on 932 participants, with 74% having complete measurements.
• Randomization proportions remained consistent with 51% receiving testosterone and 49% placebo.
• Baseline characteristics table title was updated to reflect the corrected participant number (n=932).
• The corrections do not alter the study's overall findings but ensure accurate data reporting.

Clinical Implications

Clinicians referencing the T4DM study should note the corrected participant numbers to accurately interpret the data on testosterone therapy's effects. These corrections reinforce the importance of precise data reporting in clinical trials to maintain confidence in study outcomes and subsequent clinical decision-making.

Conclusion

The erratum corrects minor numerical inaccuracies in participant counts within the T4DM study, ensuring the integrity of the reported data without impacting the study's conclusions on testosterone therapy and male sexual function.

References

1. Wittert GA et al. 2025 -- Impact of Testosterone Therapy on Male Sexual Function: A Secondary Analysis from the T4DM Study (Erratum)