title: Male hormonal contraception: a double-blind, placebo-controlled study.
abstract: BACKGROUND
  This study was performed to assess spermatogenesis suppression and safety of a new combination of an etonogestrel (ENG) implant combined with testosterone undecanoate (TU) injections for male contraception. This is the first large placebo-controlled study for male hormonal contraception.
  
  
  METHODS
  In this double-blind, multicenter study, we randomly assigned 354 healthy men to receive either a low- or high-release ENG implant sc combined with im TU injections (750 mg every 10 or 12 wk or 1000 mg every 12 wk) or placebo implant and injections. Treatment duration was 42 or 44 wk and posttreatment follow-up at least 24 wk.
  
  
  RESULTS
  Overall, spermatogenesis was suppressed to 1 million/ml or less at wk 16 in 89% of men, with approximately 94% in two high-release ENG groups. Suppression was maintained up to the end of the treatment period in 91% of men. For all men who completed the treatment period, 3% never achieved 1 million/ml or less. Median recovery time to a sperm concentration above 20 million/ml was 15 wk (mean 17 wk, 95% confidence interval 16-18 wk). Treatment was well tolerated. As compared with the placebo group, more men in the active treatment groups reported adverse events such as weight gain, mood changes, acne, sweating, or libido change. For both spermatogenesis suppression and safety, differences were small between the active treatment groups.
  
  
  CONCLUSIONS
  The combination of an ENG implant with TU injections is a well-tolerated male hormonal method, providing effective and reversible suppression of spermatogenesis. Although the results are good, there is still room for improvement, possibly by adjusting the dose regimen or changing the mode of application.
authors.affiliation: Global Clinical Development Department, Organon, part of Schering-Plough, Oss, The Netherlands. ellen.mommers@organon.com
authors.forename: Ellen
authors.initials: E
authors.lastname: Mommers
authors.forename: Wendy M
authors.initials: WM
authors.lastname: Kersemaekers
authors.forename: Jörg
authors.initials: J
authors.lastname: Elliesen
authors.forename: Marc
authors.initials: M
authors.lastname: Kepers
authors.forename: Dan
authors.initials: D
authors.lastname: Apter
authors.forename: Hermann M
authors.initials: HM
authors.lastname: Behre
authors.forename: Jennifer
authors.initials: J
authors.lastname: Beynon
authors.forename: Pierre M
authors.initials: PM
authors.lastname: Bouloux
authors.forename: Antonietta
authors.initials: A
authors.lastname: Costantino
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Gerbershagen
authors.forename: Lars
authors.initials: L
authors.lastname: Grønlund
authors.forename: Doris
authors.initials: D
authors.lastname: Heger-Mahn
authors.forename: Ilpo
authors.initials: I
authors.lastname: Huhtaniemi
authors.forename: Evert L
authors.initials: EL
authors.lastname: Koldewijn
authors.forename: Corinna
authors.initials: C
authors.lastname: Lange
authors.forename: Svend
authors.initials: S
authors.lastname: Lindenberg
authors.forename: M Cristina
authors.initials: MC
authors.lastname: Meriggiola
authors.forename: Eric
authors.initials: E
authors.lastname: Meuleman
authors.forename: Peter F A
authors.initials: PF
authors.lastname: Mulders
authors.forename: Eberhard
authors.initials: E
authors.lastname: Nieschlag
authors.forename: Antti
authors.initials: A
authors.lastname: Perheentupa
authors.forename: Andrew
authors.initials: A
authors.lastname: Solomon
authors.forename: Leena
authors.initials: L
authors.lastname: Väisälä
authors.forename: Frederick C
authors.initials: FC
authors.lastname: Wu
authors.forename: Michael
authors.initials: M
authors.lastname: Zitzmann
mesh_terms: D000328:Adult; D008076:Cholesterol, HDL / Q000097:blood; D003272:Contraceptive Agents, Male / Q000008:administration & dosage*; D017135:Desogestrel / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004343:Drug Implants; D004359:Drug Therapy, Combination; D005640:Follicle Stimulating Hormone / Q000097:blood; D006801:Humans; D007267:Injections; D008297:Male; D013091:Spermatogenesis / Q000187:drug effects; D013739:Testosterone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: D008076:Cholesterol, HDL; D003272:Contraceptive Agents, Male; D004343:Drug Implants; C044815:etonogestrel; D013739:Testosterone; D017135:Desogestrel; D005640:Follicle Stimulating Hormone; C010792:testosterone undecanoate