TY - JOUR
T1 - Prostate size in hypogonadal men treated with a nonscrotal permeation- enhanced testosterone transdermal system
AU - Meikle, A. Wayne
AU - Arver, Stefan
AU - Dobs, Adrian S.
AU - Adolfsson, Jan
AU - Sanders, Steven W.
AU - Middleton, Richard G.
AU - Stephenson, Robert A.
AU - Hoover, Donald R.
AU - Rajaram, Lakshiminaryan
AU - Mazer, Norman A.
N1 - Funding Information:
Support for these studies was provided by LJSPHS grants MO1 RR-00064, DK-45760, DK-43344, Swedish Medical Research Council (MFR) 11615, and TheraTech, Inc. A.W.M., S.A., A.S.D., R.G.M., D.R.H.,].A., and R.A.S. were independent from TheraTech and contributed to experimental design, medical evaluations, and/or data analysis of the investigation. From the Departments of Medicine and Pathology, Urology, and Pharmaceutics, University of Utah, Salt Lake City, Utah; Johns Hopkins University, Baltimore, Maryland; Departments of Obstetrics and Gynecology (Reproductive Medicine Center), Department of Urology, Karolinska Hospital, Stockholm, Sweden; and TheraTech, Inc., Salt Lake City, Utah Reprint requests: A. Wayne Meikle, M.D., University of Utah, Division of Endocrinology, 50 North Medical Drive, Salt Lake City, UT 84132 Submitted: July 11, 1996, accepted: August 20, 1996
PY - 1997/2
Y1 - 1997/2
N2 - Objectives. This study examined the effects of testosterone replacement using a nonscrotal testosterone transdermal (TTD) system on prostate size and prostate-specific antigen (PSA) levels in hypogonadal men. Methods. As part of an open-label, multicenter study, prostate volume as measured by transrectal ultrasound and PSA were assessed in 29 hypogonadal men during treatment with intramuscular testosterone enanthate (+TE), followed by 8 weeks of androgen withdrawal (-T), and then during 1 year of therapy with Androderm Testosterone Transdermal System, a nonscrotal permeation-enhanced TTD system (+TTD). Results. Mean prostate volume decreased significantly from the +TE period (17 g) compared with the T period (14 g) (P <0.001). Prostate volume increased significantly from the -T period compared with the +TTD period (18 g) (P <0.001). Maximum prostate size, comparable to that measured during +TE (P = 0.125), was reached by month 3 of +TTD therapy; prostate volume did not increase further during the remaining 9 months of +TTD therapy. Prostate volume correlated with age (P <0.01) during all three periods of observation (+TE: r = 0.69; T: r = 0.64; and +TTD: r = 0.55). No patient developed symptomatic benign prostatic hyperplasia during the treatment period. PSA levels decreased during androgen withdrawal compared with levels measured during +TE treatment (P <0.001) and rose with resumption of androgen therapy with TTD (P <0.006). However, PSA levels during +TTD replacement remained significantly lower (P <0.001) than during +TE replacement. Conclusions. Physiologic testosterone replacement in hypogonadal men was achieved using the TTD system. Prostate size during therapy with TTD was comparable to that reported for normal men. In these men treated with TTD, PSA levels were also within the normal range.
AB - Objectives. This study examined the effects of testosterone replacement using a nonscrotal testosterone transdermal (TTD) system on prostate size and prostate-specific antigen (PSA) levels in hypogonadal men. Methods. As part of an open-label, multicenter study, prostate volume as measured by transrectal ultrasound and PSA were assessed in 29 hypogonadal men during treatment with intramuscular testosterone enanthate (+TE), followed by 8 weeks of androgen withdrawal (-T), and then during 1 year of therapy with Androderm Testosterone Transdermal System, a nonscrotal permeation-enhanced TTD system (+TTD). Results. Mean prostate volume decreased significantly from the +TE period (17 g) compared with the T period (14 g) (P <0.001). Prostate volume increased significantly from the -T period compared with the +TTD period (18 g) (P <0.001). Maximum prostate size, comparable to that measured during +TE (P = 0.125), was reached by month 3 of +TTD therapy; prostate volume did not increase further during the remaining 9 months of +TTD therapy. Prostate volume correlated with age (P <0.01) during all three periods of observation (+TE: r = 0.69; T: r = 0.64; and +TTD: r = 0.55). No patient developed symptomatic benign prostatic hyperplasia during the treatment period. PSA levels decreased during androgen withdrawal compared with levels measured during +TE treatment (P <0.001) and rose with resumption of androgen therapy with TTD (P <0.006). However, PSA levels during +TTD replacement remained significantly lower (P <0.001) than during +TE replacement. Conclusions. Physiologic testosterone replacement in hypogonadal men was achieved using the TTD system. Prostate size during therapy with TTD was comparable to that reported for normal men. In these men treated with TTD, PSA levels were also within the normal range.
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U2 - 10.1016/S0090-4295(96)00445-1
DO - 10.1016/S0090-4295(96)00445-1
M3 - Article
C2 - 9037280
AN - SCOPUS:0031019638
SN - 0090-4295
VL - 49
SP - 191
EP - 196
JO - Urology
JF - Urology
IS - 2
ER -