Placebo controlled double-blind study to test the efficacy of the aromatase inhibitor atamestane in patients with benign prostatic hyperplasia not requiring operation. The Schering 90.062 Study Group.
OBJECTIVE
We tested the theoretical concept that a selective decrease in estrogens has a beneficial therapeutic effect on established benign prostatic hyperplasia.


METHODS
In a double-blind study 160 patients from 14 centers were randomized between 2 groups to receive either placebo or the aromatase inhibitor atamestane (1-methyl-androsin-1,4 diene-3 17-dione, 400 mg. daily for 48 weeks).


RESULTS
The aromatase inhibitor decreased the mean estradiol level by approximately 40% and estrone by 60%. The testosterone concentration increased by more than 40% and dihydrotestosterone increased to 30%. Analysis of clinical parameters showed no difference between placebo and atamestane.


CONCLUSIONS
The counter regulatory increase in androgens may counterbalance any positive effect of the decrease in estrogens to preserve intraprostatic homeostasis.
Gingell
J C
JC
Department of Urology, Southmead Hospital, Bristol, Great Britain.
Knönagel
H
H
Kurth
K H
KH
Tunn
U W
UW
D000368:Aged; D000735:Androstenedione / Q000031:analogs & derivatives* / Q000627:therapeutic use; D047072:Aromatase Inhibitors; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011470:Prostatic Hyperplasia / Q000188:drug therapy*
D047072:Aromatase Inhibitors; D000735:Androstenedione; C048751:atamestane