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Published-Ahead-of-Print November 28, 2007, DOI:10.2164/jandrol.107.004226
Journal of Andrology, Vol. 29, No. 3, May/June 2008
Copyright © American Society of Andrology
DOI: 10.2164/jandrol.107.004226

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Pharmacokinetics and Pharmacodynamics of Oral Testosterone Enanthate Plus Dutasteride for 4 Weeks in Normal Men: Implications for Male Hormonal Contraception

JOHN K. AMORY*,{dagger},{ddagger}, THOMAS F. KALHORN§ AND STEPHANIE T. PAGE*,{ddagger},||

From the * Center for Research in Reproduction and Contraception, {dagger} Division of General Internal Medicine, {ddagger} Department of Medicine and the § Department of Medicinal Chemistry, || Divisions of Endocrinology, Metabolism and Nutrition, University of Washington School of Medicine, Seattle, Washington.

Correspondence to: Dr John K. Amory, University of Washington, Box 356429, 1959 NE Pacific St, Seattle, WA 98195 (e-mail: jamory{at}u.washington.edu).


Oral administration of testosterone enanthate (TE) and dutasteride increases serum testosterone and might be useful for male hormonal contraception. To ascertain the contraceptive potential of oral TE and dutasteride by determining the degree of gonadotropin suppression mediated by 4 weeks of oral TE plus dutasteride, 20 healthy young men were randomly assigned to 4 weeks of either 400 mg oral TE twice daily or 800 mg oral TE once daily in a double-blinded, controlled fashion at a single site. All men received 0.5 mg dutasteride daily. Blood for measurement of serum luteinizing hormone (LH), follicle-stimulating hormone (FSH), testosterone, dihydrotesterone (DHT), and estradiol was obtained prior to treatment, weekly during treatment, and 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours after the morning dose on the last day of treatment. FSH was significantly suppressed throughout treatment with 800 mg TE once daily and after 4 weeks of treatment with 400 mg TE twice daily. LH was significantly suppressed after 2 weeks of treatment with 800 mg TE, but not with 400 mg TE. Serum DHT was suppressed and serum estradiol increased during treatment in both groups. High-density lipoprotein cholesterol was suppresed during treatment, but liver function tests, hematocrit, creatinine, mood, and sexual function were unaffected. The administration of 800 mg oral TE daily combined with dutasteride for 28 days significantly suppresses gonadotropins without untoward side effects and might have utility as part of a male hormonal contraceptive regimen.

     Key words: Androgens, FSH, LH, 5{alpha} reductase, male fertility






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