The Effects of Transdermal Dihydrotestosterone in the Aging Male: A Prospective, Randomized, Double Blind Study
Pekka Kunelius,
Olavi Lukkarinen,
Minna L. Hannuksela,
Outi Itkonen and
Juha S. Tapanainen
Division of Urology, Departments of Surgery (P.K., O.L.), Internal Medicine and Biocenter Oulu (M.L.H.), and Obstetrics and Gynecology (J.S.T.), University of Oulu, FIN-90014 Oulu; and Department of Clinical Chemistry, University of Helsinki (O.I.), FIN-00029 Helsinki, Finland
Address all correspondence and requests for reprints to: Juha Tapanainen, M.D., Ph.D., Department of Obstetrics and Gynecology, Oulu University Hospital, P.O. Box 5000, University of Oulu, FIN-90014 Oulu, Finland. E-mail: . juha.tapanainen{at}oulu.fi
Abstract
The objective of the study was to investigate the effects ofdihydrotestosterone (DHT) gel on general well-being, sexualfunction, and the prostate in aging men. A total of 120 menparticipated in this randomized, placebo-controlled study (60DHT and 60 placebo). All subjects had nocturnal penile tumescenceonce per week or less, andropause symptoms, and a serum T levelof 15 nmol/liter or less and/or a serum SHBG level greater than30 nmol/liter. The mean age was 58 yr (range, 50–70 yr).Of these subjects, 114 men completed the study. DHT was administeredtransdermally for 6 months, and the dose varied from 125–250mg/d. General well-being symptoms and sexual function were evaluatedusing a questionnaire, and prostate symptoms were evaluatedusing the International Prostate Symptoms Score, transrectalultrasonography, and assay of serum prostate-specific antigen.
Early morning erections improved transiently in the DHT groupat 3 months of treatment (P < 0.003), and the ability tomaintain erection improved in the DHT group compared with theplacebo group (P < 0.04). No significant changes were observedin general well-being between the placebo and the DHT group.Serum concentrations of LH, FSH, E2, T, and SHBG decreased significantlyduring DHT treatment. Treatment with DHT did not affect liverfunction or the lipid profile. Hemoglobin concentrations increasedfrom 146.0 ± 8.2 to 154.8 ± 11.4 g/liter, andhematocrit from 43.5 ± 2.5% to 45.8 ± 3.4% (P< 0.001). Prostate weight and prostate-specific antigen levelsdid not change during the treatment. No major adverse eventswere observed.
Transdermal administration of DHT improves sexual function andmay be a useful alternative for androgen replacement. As estrogensare thought to play a role in the pathogenesis of prostate hyperplasia,DHT may be beneficial, compared with aromatizing androgens,in the treatment of aging men.
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