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This version published online on January 5, 2005
Journal of Clinical Endocrinology & Metabolism, doi:10.1210/jc.2004-1852
A more recent version of this article appeared on April 1, 2005
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Submitted on September 20, 2004
Accepted on December 29, 2004

NORETHISTERONE ENANTHATE PLUS TESTOSTERONE UNDECANOATE FOR MALE CONTRACEPTION: EFFECTS OF VARIOUS INJECTION INTERVALS ON SPERMATOGENESIS, REPRODUCTIVE HORMONES, TESTIS AND PROSTATE

MC Meriggiola*, A Costantino, F Saad, L D'Emidio, AM Morselli Labate, A Bertaccini, WJ Bremner, I Rudolph, M Ernst, B Kirsch, G Martorana, and G Pelusi

Dept of Obstetrics and Gynecology, Dept of Internal Medicine and Gastroenterology, Dept. of Urology, S. Orsola-Malpighi Hospital and University of Bologna, Bologna, Italy, Dept. of Medicine, University of Washington, Seattle, WA, Schering AG, Berlin, Germany, and Jenapharm GmbH & Co. KG, Germany

* To whom correspondence should be addressed. E-mail: crismeri{at}med.unibo.it.

The goal of this study was to find the most favorable injection interval of norethisterone enanthate (NETE) plus testosterone undecanoate (TU) in terms of gonadotropin, sperm suppression and prostatic effects. Fifty normal men were randomly assigned to receive NETE 200 mg plus TU 1000 mg every 8 weeks (n = 10; NETE-8), every 12 weeks (n = 10; NETE-12), every 6 weeks for 12 weeks and then every 12 weeks (n = 10; NETE-6/12) and every 6 weeks for 12 weeks and thereafter TU 1000 mg plus Placebo every 12 weeks (n = 10; NETE-6/12/0), and Placebo plus Placebo every 6 weeks for 12 weeks and then every 12 weeks (n = 10; NETE-0/0) for 48 weeks. Semen analyses, blood drawings, physical examinations, and prostate ultrasounds were performed throughout the study. Of the men in the 8-weekly injection group, 90% (9 out of 10) achieved azoospermia, compared with 37.5% (3 out of 8) in the 12-weekly injection group (P = 0.019). TU plus placebo injected every 12 weeks did not maintain sperm suppression. Prostate volumes did not change significantly in either group. In conclusion, these data suggest that the combined administration of NETE and TU at 8-week interval represents an effective hormonal contraceptive regimen.
Key words: spermatogenesis • gonadotropins • contraception • male • norethisterone enanthate • testosterone undecanoate




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