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MEDICAL JOURNAL OF AUSTRALIA. 1991 Feb 18; 154(4):230-3.The 1st published study of efficacy of a hormonal male contraceptive, by the WHO Special Programme of Research, Development and Research Training in Human Reproduction, employed weekly deep intramuscular injections of testosterone enanthate. 271 fertile married men at 10 centers worldwide participated for 18 months. The goal of this preliminary study was to determine if azoospermia was necessary or sufficient for effective contraception. Azoospermia was produced in 157 men, who then participated in a 12-month trial. There was 1 pregnancy, for a failure rate of 0.8 per 100 person-years, highly effective in comparison with oral contraceptives, IUDs and injectables. There was a 12% annual discontinuation rate reasons cited were acne (4%), behavioral effects such as aggression or increased libido (1%), and other medical reasons (1%), e.g. weight gain, polycythemia, hyperlipidemia or hypertension. Recruitment of study subjects was difficult in developed countries until direct public appeals met with success. Future developments in the male hormonal contraceptive field will require a more acceptable administration route. To develop this, longer-acting injectables or implants utilizing testosterone cybutanate (20AET-1), or other combinations of testosterone with a progestin or a gonadotropin-releasing hormone antagonist are envisioned. The effect of incomplete azoospermia and the fertilizing capacity of remaining sperm is a serious issue for research. Each more crucial is resolution of the social, political and legal problems involved in male hormonal contraceptive research. Probably reform of the US product liability litigation procedures will do more to advance contraceptive development than any other single factor.