[Jiarong Tablets combined with Testosterone Undecanoate Capsules for late-onset hypogonadism in males: A multicentered clinical trial]

Abstract

Objective: To evaluate the efficacy and safety of Jiarong Tablets (JRT) combined with Testosterone Undecanoate Capsules (TUC) in the treatment of late-onset hypogonadism (LOH) in males.

Methods: This randomized open multicentered clinical trial included 200 cases of LOH meeting the inclusion, which were equally randomized into a control (aged ［51.09 ± 5.6］ yr) and a trial group (aged ［50.46 ± 5.2］ yr) to be treated with oral TUC (40 mg, bid) and TUC+JRT (0.92 g, tid) respectively for 12 successive weeks. We obtained the Aging Males' Symptoms (AMS) and IIEF-5 scores, serum total testosterone (TT) content, red blood cell (RBC) count, hepatic and renal function indexes and glucose and total PSA levels before and after treatment, and compared them between the two groups of patients.

Results: Totally, 191 of the LOH patients completed the experiment, 95 in the control and 96 in the trial group. After 12 weeks of treatment, the patients in the trial group, compared with the controls, showed significant improvement in the AMS score (20.6 ± 5.7 vs 31.9 ± 6.1, P < 0.05), IIEF-5 score (20.3 ± 3.1 vs 16.3 ± 3.8, P < 0.05) and serum TT level (［16.1 ± 3.9］ vs ［12.7 ± 3.4］ nmol/L, P < 0.05). There were no significant adverse events or abnormalities in the RBC count, hepatic and renal functions, or glucose and total PSA levels in the two groups of patients before and after medication.

Conclusions: JRT combined with TUC is safe and effective and superior to TUC alone in the treatment of LOH in males.

Keywords: Jiarong Tablets; clinical trial; multicentered; testosterone; late-onset hypogonadism.