OBJECTIVE: To determine the effects of dehydroepiandrosterone (DHEA) supplementation on the pharmacokinetics of DHEA and its metabolites and the reproductive axis of healthy young men. DESIGN: A prospective, randomized, double-blind, placebo-controlled pharmacokinetic study. SETTING:General Clinical Research Center and laboratories at the Keck School of Medicine of the University of Southern California, Los Angeles, California. PATIENT(S): Fourteen healthy men, ages 18-42 years. INTERVENTION(S): Daily oral administration of placebo (n = 5), 50 mg DHEA (n = 4), or 200 mg DHEA (n = 5) for 6 months. Blood samples were collected at frequent intervals on day 1 and at months 3 and 6 of treatment. MAIN OUTCOME MEASURE(S): Quantification of DHEA, DHEA sulfate (DHEAS), androstenedione, T, E(2), dihydrotestosterone (DHT), and 5alpha-androstane-3alpha-17beta-diol glucuronide (ADG). Physical examination, semen analysis, serum LH, FSH, prostate-specific antigen, and general chemistries were carried out. RESULT(S): Baseline DHEA, DHEAS, and ADG levels increased significantly from day 1 to months 3 and 6 in the DHEA treatment groups but not in the placebo group. No significant changes were observed in pharmacokinetic values. Clinical parameters were not affected. CONCLUSION(S): DHEA, DHEAS, and ADG increased significantly during 6 months of daily DHEA supplementation. Although the pharmacokinetics of DHEA and its metabolites are not altered, sustained baseline elevation of ADG, a distal DHT metabolite, raises concerns about the potential negative impact of DHEA supplementation on the prostate gland.
RCT Entities:
OBJECTIVE: To determine the effects of dehydroepiandrosterone (DHEA) supplementation on the pharmacokinetics of DHEA and its metabolites and the reproductive axis of healthy young men. DESIGN: A prospective, randomized, double-blind, placebo-controlled pharmacokinetic study. SETTING: General Clinical Research Center and laboratories at the Keck School of Medicine of the University of Southern California, Los Angeles, California. PATIENT(S): Fourteen healthy men, ages 18-42 years. INTERVENTION(S): Daily oral administration of placebo (n = 5), 50 mg DHEA (n = 4), or 200 mg DHEA (n = 5) for 6 months. Blood samples were collected at frequent intervals on day 1 and at months 3 and 6 of treatment. MAIN OUTCOME MEASURE(S): Quantification of DHEA, DHEA sulfate (DHEAS), androstenedione, T, E(2), dihydrotestosterone (DHT), and 5alpha-androstane-3alpha-17beta-diol glucuronide (ADG). Physical examination, semen analysis, serum LH, FSH, prostate-specific antigen, and general chemistries were carried out. RESULT(S): Baseline DHEA, DHEAS, and ADG levels increased significantly from day 1 to months 3 and 6 in the DHEA treatment groups but not in the placebo group. No significant changes were observed in pharmacokinetic values. Clinical parameters were not affected. CONCLUSION(S): DHEA, DHEAS, and ADG increased significantly during 6 months of daily DHEA supplementation. Although the pharmacokinetics of DHEA and its metabolites are not altered, sustained baseline elevation of ADG, a distal DHT metabolite, raises concerns about the potential negative impact of DHEA supplementation on the prostate gland.
Authors: Julia T Arnold; Nora E Gray; Ketzela Jacobowitz; Lavanya Viswanathan; Pui W Cheung; Kimberly K McFann; Hanh Le; Marc R Blackman Journal: J Steroid Biochem Mol Biol Date: 2008-06-22 Impact factor: 4.292