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Norethisterone Enanthate Plus Testosterone Undecanoate for Male Contraception: Effects of Various Injection Intervals on Spermatogenesis, Reproductive Hormones, Testis, and Prostate

Departments of Obstetrics and Gynecology (M.C.M., A.C., L.D., G.P.), Internal Medicine and Gastroenterology (A.M.M.L.), and Urology (A.B., G.M.), S. Orsola-Malpighi Hospital and University of Bologna, 40138 Bologna, Italy; Department of Medicine (W.J.B.), University of Washington, Seattle, Washington 98108; Schering AG (F.S.), 10115 Berlin, Germany; and Jenapharm GmbH & Co. KG (I.R., M.E., B.K.), D-07745 Jena, Germany

Address all correspondence and requests for reprints to: M. Cristina Meriggiola, M.D., Ph.D., Department of Obstetrics and Gynecology, S. Orsola Hospital, Via Massarenti 13, 40138 Bologna, Italy. 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 wk (n = 10), every 12 wk (n = 10), every 6 wk for 12 wk and then every 12 wk (n = 10), and every 6 wk for 12 wk and thereafter TU 1000 mg plus placebo every 12 wk (n = 10), and placebo plus placebo every 6 wk for 12 wk and then every 12 wk (n = 10) for 48 wk. Semen analyses, blood drawings, physical examinations, and prostate ultrasounds were performed throughout the study. Of the men in the 8-wk injection group, 90% (nine of 10) achieved azoospermia, compared with 37.5% (three of eight) in the 12-wk injection group (P = 0.019). TU plus placebo injected every 12 wk 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-wk intervals represents an effective hormonal contraceptive regimen.

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