Efficacy and Safety of TESTOPEAK™ in Improving Symptoms of Andropause in Korean Men: An 8-Week, Single-Center, Randomized, Parallel-Group, Placebo-Controlled Trial
Abstract
TESTOPEAK™ (KGC08EA; Korea Ginseng Corporation, Daejeon, Korea) has been developed to improve the symptoms of andropause. This 8-week, randomized, double-blind, parallel-group, placebo-controlled study was conducted to assess its efficacy and safety in improving the symptoms of andropause in Korean men. The eligible subjects were randomized either to the trial group or the control group, followed by an 8-week treatment period. The subjects of the trial group (n = 48) and those of the control group (n = 48) were orally given a tablet of TESTOPEAK™ and its matching placebo, respectively, at a dose of 500 mg/day once daily in the morning within 30 min after meal during an 8-week treatment period. Efficacy outcome measures include differences in changes in the Aging Male’s Symptoms (AMS) scores, the Androgen Deficiency in Aging Male (ADAM) scores, the International Index of Erectile Function (IIEF) scores, hormone biomarker levels, lipid biomarker levels and body compositions at 8 weeks from baseline between the two treatment arms. Incidences of adverse events (AEs) served as safety outcome measures. There were significant differences in changes in the AMS scores, the ADAM scores, the IIEF scores, total testosterone, free testosterone and sex hormone binding globulin (SHBG) levels, total cholesterol, high-density lipoprotein (HDL) cholesterol and low-density lipoprotein (LDL) cholesterol levels and triglyceride levels and visceral and total fat area at 8 weeks from baseline…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 48 participants or records.
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