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Evidence for Tissue Selectivity of the Synthetic Androgen 7-Methyl-19-Nortestosterone in Hypogonadal Men

Medical Research Council Human Reproductive Sciences Unit, University of Edinburgh (R.A.A.), Edinburgh, United Kingdom EH16 4SB; Department of Clinical Biochemistry, Royal Infirmary (A.M.W., N.S.), Glasgow, United Kingdom G4 0SF; and Center for BioMedical Research, The Population Council (N.K., K.S.), New York, New York 10017

Address all correspondence and requests for reprints to: Dr. Richard A. Anderson, Medical Research Council Human Reproductive Sciences Unit, Center for Reproductive Biology, University of Edinburgh, Chancellor’s Building, 49 Little France Crescent, Edinburgh, United Kingdom EH16 4SB. E-mail: r.a.anderson{at}hrsu.mrc.ac.uk.

The potent synthetic androgen 7-methyl-19-nortestosterone (MENT) is resistant to 5-reductase but is a substrate for aromatase. It may therefore offer selective sparing of the prostate gland while supporting other androgen-dependent tissues. MENT acetate implants were administered for 24 wk to 16 hypogonadal men, randomly allocated to 1 or 2 implants (groups I and II, respectively; releasing 400 µg/d·implant). Hemoglobin concentration and hematocrit were maintained during MENT treatment. Prostate volume fell in group I and to a small, but statistically nonsignificant, degree in group II; the level of prostate-specific antigen fell significantly in both. Lumbar spine bone mineral density decreased in both groups. Sexual behavior and erectile function declined in group I, but were maintained in group II. Thus, overall, one MENT implant appeared to provide subphysiological androgen replacement. The 2-implant dose of MENT was able to maintain most androgen-dependent functions, except bone mass, and there was evidence to support selective sparing of the prostate gland. These results demonstrate for the first time in humans the selectivity of MENT in tissues dependent on 5-reductase. In addition, our data are consistent with the importance of adequate estrogenicity as part of the necessary spectrum of activity of an androgen for replacement therapy in men.

This work was supported by the United Kingdom Medical Research Council and the International Committee for Contraception Research of The Population Council, part of the Contraceptive Development Program of the Center for Biomedical Research.

Abbreviations: BMD, Bone mineral density; CV, coefficient of variation; DEXA, dual energy x-ray absorptiometry; DHT, dihydrotestosterone; MENT, 7-methyl-19-nortestosterone; MENTAc, 7-methyl-19-nortestosterone acetate; NPT, nocturnal penile tumescence; PSA, prostate-specifice antigen; SES, Sexuality Experience Scales.

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