After two control examinations, normal healthy male volunteers were given a single im injection of 600 mg TB (group I; n = 4) and 1200 mg TB (group II; n = 8) on day 0. Follow-up examinations were performed every 2 weeks up to week 32. In both groups mean serum T levels remained in the normal physiological range throughout the study course.
Abstract
Testosterone alone and the combination of gestagens and gonadotropin-releasing hormone antagonists with testosterone represent the most feasible potential agents for hormonal male contraception. The World Health Organization's Special Program of Research, Development, and Research Training in Human Reproduction has initiated a testosterone ester synthesis program and identified testosterone buciclate (TB) as the most promising approach to suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH). This paper presents the results of the first clinical trial of TB. 12 men were given a single intramuscular injection of 600 mg (group I) or 1200 mg (group II) of TB and followed every 2 weeks for up to 32 weeks. Mean serum testosterone levels in both groups remained in the normal physiological range throughout the study period. Serum levels of dihydrotestosterone showed a time- and dose-dependent increase in group II. Although no suppression of spermatogenesis was observed in the 4 men in group I, azoospermia occurred in 3 of the 8 volunteers in group II beginning at week 10 and persisting to weeks 14, 20, and 22, respectively. In the remaining 5 men in group II, mean serum LH and FSH values were depressed to values near the lower limit of normal. Serum sex hormone-binding globulin and free testosterone were lower in responders than non-responders to TB. The range of responses recorded in group II suggests that men have a different hormonal equilibrium or different set-point for regulation of gonadotropin secretion and, thus, susceptibility to exogenous hormonal steroids.
...but, thanks for the tip.
