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.

• Authors: Eric J H Meuleman, Jean-Jacques Legros, Pierre M G Bouloux, Amy O Johnson-Levonas, Marion J G H Kaspers, Jolanda M H Elbers, T B Paul Geurts, Alan G Meehan, Study 43203 Investigators
• Journal: The aging male : the official journal of the International Society for the Study of the Aging Male (Aging Male) Vol. 18 Issue 3 Pg. 157-63 ( 2015) ISSN: 1473-0790 [Electronic] England
• PMID: 26030346 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Androgens
• Testosterone
• testosterone undecanoate

Topics

• Administration, Oral
• Aged
• Aging
• Androgens (administration & dosage)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Humans
• Hypogonadism (drug therapy, physiopathology)
• Lower Urinary Tract Symptoms (drug therapy, etiology)
• Male
• Middle Aged
• Prostatic Hyperplasia (complications)
• Testosterone (administration & dosage, analogs & derivatives, blood)