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.
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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)
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Chemical References |
- Androgens
- Testosterone
- testosterone undecanoate
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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)
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