Effects of long-term oral testosterone undecanoate therapy on urinary symptoms: data from a 1-year, placebo-controlled, dose-ranging trial in aging men with symptomatic hypogonadism

Abstract

Background: There has been a longstanding question as to whether testosterone therapy could precipitate or worsen urinary symptoms in aging men. We investigated the effects of 1-year oral testosterone undecanoate (TU) therapy on urinary symptoms in aging, hypogonadal men.

Methods: A total of 322 men ≥50 years with symptomatic testosterone deficiency participated in a 1-year, randomized, multicenter, double-blind trial. Patients received placebo or oral TU 80 mg/day, 160 mg/day, or 240 mg/day.

Results and limitations: Compared with placebo, treatment with oral TU at doses of 80 mg/day and 160 mg/day resulted in no significant change in IPSS urinary symptoms or quality of life (QoL) scores. Treatment with oral TU 240 mg/day led to a statistically significant, but clinically insignificant, improvement in IPSS total score and a significant improvement in IPSS QoL score. None of the TU doses tested had a significant effect on PSA or PV.

Conclusions: Long-term oral TU therapy had no deleterious effects on IPSS total score and did not change PV and PSA in aging, hypogonadal men. Oral TU therapy at a dose of 240 mg/day may even improve IPSS QoL score.

• International prostatic symptoms score
• oral testosterone undecanoate
• placebo
• prostate-specific antigen
• prostate volume
• symptomatic hypogonadism

Acknowledgements

The authors thank the study investigators and their staff for their assistance in conducting this trial, and the study subjects for their willing participation in this research. The authors also wish to thank Kathleen Newcomb, Jennifer Rotonda, and Kristen Lewis of Merck & Co., Inc., for their assistance in preparing this paper for publication.

Declaration of interest

M.J.G.H.K., A.J.-L and A.G.M. are employees of Merck & Co., Inc., Whitehouse Station, NJ, sponsor of this study. J.M.H.E. and T.B.P.G. were employees of MSD Oss, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ. P.M.G.B., J.J.L. and E.J.M. have received lecture fees from the sponsor. No other potential conflict of interest relevant to this article was reported. All authors are responsible for the work described in this paper. M.J.G.H.K., A.J.-L., A.G.M., J.M.H.E., T.B.P.G., P.M.G.B., J.J.L. and E.J.M. were involved in at least one of the following: [conception, design, acquisition, analysis, statistical analysis, interpretation of data] and [drafting the manuscript and/or revising/reviewing the manuscript for important intellectual content]. All authors provided final approval of the version to be published. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

This study was funded by Organon N.V. (a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ), Oss, The Netherlands (Protocol # 43203).

Clinical trial registry: This trial was registered at www.clinicaltrials.gov under number NCT00434824 (http://www.clinicaltrials.gov/ct2/show/NCT00434824)