A randomized, controlled study of treatment with ojayeonjonghwan for patients with late onset hypogonadism.

OBJECTIVES: We investigate the effects of Ojayeonjonghwan (KH-204) in men with late-onset hypogonadism (LOH) symptoms.

MATERIAL AND METHODS: Initial PSA, testosterone, lipid profile and questionnaires about LOH-related symptoms were checked. After 8 weeks of the treatment (control or KH-204), questionnaires and serological tests were repeated to evaluate the efficacy of the agent. The changes of variables in each group and the difference between two groups were compared.

RESULTS: A total of 78 men were enrolled, and randomly assigned to the control group (n = 39) or KH-204 group (n = 39). Baseline characteristics of both group are comparable. AMS total score of control and KH-204 group were both improved at 8 weeks (p = .010, <.001), and there was a statistically significant difference between the two groups (favorable in KH-204 group, p = .006). At 8 weeks, total IIEF score of control and KH-204 group were both improved, and there was no statistically significant difference in the degree of improvement between the two groups (p = .303). There was no statistically significant difference of laboratory findings, in intra-group changes and inter-group comparisons.

CONCLUSIONS: KH-204 was found to be effective in all LOH symptoms without changing of laboratory results. KH-204 may be safely used for treatment of male with LOH-related symptoms.