title: Testosterone undecanoate maintains spermatogenic suppression induced by cyproterone acetate plus testosterone undecanoate in normal men.
abstract: In this study we evaluated whether testosterone undecanoate (TU), alone or combined with low dose cyproterone acetate (CPA), can maintain spermatogenic suppression induced by higher doses of CPA plus TU. Twenty-four men received for 12 wk 20 mg/d CPA plus 1000 mg/6 wk TU and then 1000 mg/8 wk TU plus 20 mg/d CPA (n = 8), 2 mg/d CPA (n = 8), or plus placebo (n = 8) for 32 wk. Blood samples, physical examinations, hormones, chemistry, hematology, semen analysis, and sexual/behavioral assessments were performed throughout the study. Sperm counts decreased to less than 1 million/ml in all subjects by wk 12, and 54% of them achieved azoospermia. Suppression of sperm counts was maintained until wk 44. Serum LH and FSH levels were suppressed by wk 12 of hormone administration and remained suppressed until wk 44. No significant changes in any biochemical parameters were detected at wk 44 in any group. There was a slight increase in total prostate volume to within the normal range at wk 44 that returned to baseline 1 yr after stopping hormone administration. In conclusion, TU alone or combined with lower doses of CPA maintains sperm suppression induced by higher dose CPA plus TU for 32 wk. This prototype regimen represents a promising male contraceptive regimen.
authors.affiliation: Department of Obstetrics and Gynecology, S Orsola-Malpighi Hospital and University of Bologna, 40138 Bologna, Italy.
authors.forename: M C
authors.initials: MC
authors.lastname: Meriggiola
authors.forename: A
authors.initials: A
authors.lastname: Costantino
authors.forename: S
authors.initials: S
authors.lastname: Cerpolini
authors.forename: W J
authors.initials: WJ
authors.lastname: Bremner
authors.forename: D
authors.initials: D
authors.lastname: Huebler
authors.forename: A M
authors.initials: AM
authors.lastname: Morselli-Labate
authors.forename: B
authors.initials: B
authors.lastname: Kirsch
authors.forename: A
authors.initials: A
authors.lastname: Bertaccini
authors.forename: C
authors.initials: C
authors.lastname: Pelusi
authors.forename: G
authors.initials: G
authors.lastname: Pelusi
mesh_terms: D000328:Adult; D003272:Contraceptive Agents, Male / Q000008:administration & dosage / Q000494:pharmacology*; D017373:Cyproterone Acetate / Q000008:administration & dosage / Q000494:pharmacology*; D004305:Dose-Response Relationship, Drug; D004357:Drug Synergism; D005640:Follicle Stimulating Hormone / Q000037:antagonists & inhibitors / Q000097:blood; D006801:Humans; D007986:Luteinizing Hormone / Q000037:antagonists & inhibitors / Q000097:blood; D008297:Male; D012016:Reference Values; D016037:Single-Blind Method; D013076:Sperm Count; D013091:Spermatogenesis / Q000187:drug effects*; D013739:Testosterone / Q000031:analogs & derivatives* / Q000494:pharmacology*; D013997:Time Factors
chemical_list: D003272:Contraceptive Agents, Male; D013739:Testosterone; D017373:Cyproterone Acetate; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone; C010792:testosterone undecanoate