Efficacy and Safety of 5-Aminolevulinic Acid for Patients with Symptoms of Late-Onset Hypogonadism: A Preliminary Study.

Abstract

PurposeAs the concept of late-onset hypogonadism (LOH) has gained increased attention, the treatment of eugonadal patients with LOH symptom has become a clinical problem. Previous studies have shown the possible benefits of 5-aminolevulinic acid (5-ALA) on the somatic, psychological and sexual functions. We therefore conducted this randomized, double-blind, placebo-controlled study to confirm the efficacy and safety of 5-ALA for LOH symptoms.Materials and MethodsThirty-two eugonadal subjects with LOH symptoms were randomly divided into a 5-ALA group (n=15) and a placebo group (n=17). Treatment was continued for 8 weeks. The change of the Aging Males’ Symptoms (AMS) scale score and several biochemical and endocrinological variables during treatment were compared between the groups.ResultsAfter treatment, the change in the total AMS in the 5-ALA group was significantly greater than that in the placebo group (-7.4±4.7 vs. -4.9±4.9, p=0.029). However, the differences between the groups in the change of the somatic, psychological, and sexual sub-scores of the AMS did not reach the statistical significance, although these changes in the 5-ALA group were greater than those in the placebo group. Furthermore, the change in the biochemical and endocrinological variables in the two groups did not differ to a statistically significant extent. During the 8-week treatment period, no patients discontinued 5-ALA due to treatment-emergent adverse events (TEAEs).ConclusionsThe intake of 5-ALA for 8 weeks was beneficial for eugonadal patients with symptoms of LOH and no severe TEAEs was experienced. 5-ALA should be considered as an option for those patients.