Login to Access Video or Poster Abstract: MP91-12
Sources of Funding: Bayer Pharma AG partially funded data entry and statistical analyses.

Introduction

Long-term data for testosterone therapy (TTh) on erectile function in hypogonadal men published so far are from observational studies without a control group. We present registry data including an untreated hypogonadal control group.

Methods

Registry study in 656 men with testosterone ≤350 ng/dL and hypogonadal symptoms. 360 received TU 1000 mg/12 weeks following an initial 6-week interval (T-group). 296 men opted against TTh and served as controls (CTRL). 8-year data are presented. Changes over time between groups were compared by a mixed effects model for repeated measures with a random effect for intercept and fixed effects for time, group and their interaction. Changes were adjusted for age, weight, waist circumference, blood pressure, fasting glucose, lipids and quality of life to account for baseline differences between groups. In order to further validate results, propensity matching was performed for baseline age, BMI, and waist circumference. 82 men in each group fulfilled criteria.

Results

Total group: mean age was 57.4±7.3 years in the T-group and 64.8±4.3 in CTRL, median follow-up time 7 years for both._x000D_ In the T-group, T levels rose from 285±37 ng/dL to trough levels (measured prior to the following injection) between 450 and 500 ng/dL (p<0.0001). In CTRL, T levels remained stable between 260 and 280 ng/dL. _x000D_ In the T group, IIEF-EF (maximum score: 30) increased from 19.5±5.0 to 25.9±3.0 with a change from baseline of 6.0 points. The improvement was statistically significant for the first four years and remained statistically significant vs baseline throughout the observation time and stable compared to previous years. In the CTRL group, IIEF-EF decreased from 20.5±3.1 to 11.7±1.6 after 8 years by 9.5 points (p<0.0001 for both)._x000D_ _x000D_ Propensity-matched group: mean age was 61.7±5.1 years in the T-group and 61.6±2.9 in CTRL, median follow-up time 8 years in the T-group and 7 in CTRL._x000D_ In the T-group, T levels rose from 277±41 ng/dL to trough levels between 470 and 515 ng/dL (p<0.0001). In CTRL, T levels remained stable between 250 and 280 ng/dL. _x000D_ In the T group, IIEF-EF (maximum score: 30) increased from 19.5±5.6 to 25.8±3.9 with a change from baseline of 5.9 points. The improvement was statistically significant for the first three years and remained statistically significant vs baseline throughout the observation time and stable compared to previous years. In CTRL, IIEF-EF decreased from 20.2±3.3 to 12.4±1.0 after 8 years by 8.6 points (p<0.0001 for both)._x000D_

Conclusions

Erectile function is improved and preserved for a prolonged period of time by TTh in hypogonadal men and deteriorates in untreated hypogonadal men.

Funding

Bayer Pharma AG partially funded data entry and statistical analyses.