Androgens and sexual function: a placebo-controlled, randomized, double-blind study of testosterone vs. dehydroepiandrosterone in men with sexual dysfunction and androgen deficiency.
OBJECTIVE
Supplemental administration of androgens has been advocated for men with sexual dysfunction (SD) and hypoandrogenism. The preponderance of evidence indicates that most delivery forms of testosterone (T) are effective but the role of dehydroepiandrosterone (DHEA) is controversial. A placebo-controlled, randomized trial of oral androgen (T versus DHEA) supplementation was carried out to determine their efficacy.


METHODS
Eighty-six men with SD and decreased levels of serum T and/or DHEA, participated in a study receiving oral T undecanoate (OTU) (n = 29) 80 mg twice daily, DHEA (n = 28) 50 mg twice daily, or placebo (n = 29). Outcomes included evaluation of sexual performance by the International Index of Erectile Function (IIEF), the Androgen Deficiency in the Aging Male (ADAM), Aging Male Symtom Scale (AMS), and Global Assessment Questionnaire (GAQ) questionnaires. Biochemical evaluations included measurement of T and DHEA, prolactin, gonadotropins, and PSA.


RESULTS
Seventy-nine men completed the study. There were no significant differences in outcomes as assessed by four different instruments: the ADAM, IIEF, AMS, and GAQ in regard to sexual interest or erectile function. Biochemically, a significant increase in serum DHEA between baseline and final visit was documented in the group receiving DHEA. The levels of T, on the other hand, increased insignificantly between entry and final visit in the T cohort. No biochemical changes were observed in the placebo group. Levels of PSA remained stable in all three groups.


CONCLUSIONS
This study did not suggest a clinical benefit of OTU or DHEA supplementation in men with hypoandrogenism and SD. The recommended dose of OTU may have been inadequate or poorly absorbed. Increased doses or an alternative T delivery form may result in a different response.
Morales
Alvaro
A
Department of Urology, Centre for Applied Urological Research, Queen's University, Kingston, Ontario, Canada. moralesa@queensu.ca
Black
Angela
A
Emerson
Laurel
L
Barkin
Jack
J
Kuzmarov
Irwin
I
Day
Andrew
A
D000368:Aged; D000728:Androgens / Q000032:analysis*; D003687:Dehydroepiandrosterone / Q000008:administration & dosage* / Q000378:metabolism; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D012735:Sexual Dysfunction, Physiological / Q000188:drug therapy* / Q000503:physiopathology; D013739:Testosterone / Q000008:administration & dosage* / Q000378:metabolism
D000728:Androgens; D013739:Testosterone; D003687:Dehydroepiandrosterone