Effect of sometribove (methionyl bovine somatotropin) on mastitis in 15 full lactation trials (914 cows) in Europe and the US and 70 short-term studies (2697 cows) in eight countries was investigated. In full lactation studies, sometribove (500 mg/2 wk) was given for 252 d, commencing 60 d postpartum. Although herds varied considerably, incidence of clinical mastitis within a herd was similar for cows receiving control and sometribove treatments. Relative risk analyses indicated no treatment effect, and percentage of mastitis during treatment was similar for control and sometribove groups. A positive linear relationship existed between peak milk yield and mastitis incidence (percentage of cows contracting mastitis or cases per 100 cow days); sometribove treatment did not alter this relationship. Increases in mastitis related to milk yield increase from sometribove or related to genetic selection were similar. When expressed per unit of milk, mastitis incidence declined slightly as milk yield increased; this relationship was not altered by sometribove. No effect on clinical mastitis was observed in 70 commercial herds utilizing sometribove for 84 d. However, effects were significant for stage of lactation and milk yield. Overall, studies represented a wide range of research and commercial situations demonstrating that sometribove had no effect on incidence of clinical mastitis during the lactation of treatment. Furthermore, sometribove did not alter typical relationships between milk yield or herd factors and incidence of clinical mastitis.