Summary The relationship between oral contraceptives (OCs), menopausal hormone replacement therapy (HRT) and the risk of colorectal cancer was investigated in a case-control study conducted in northern Italy between 1985 and 1992 on 709 women with incident colorectal cancer and 992 controls admitted to hospital for a wide spectrum of acute, non-neoplastic, non-digestive tract, non-hormone-related disorders. A reduced risk of colorectal cancer was observed in women who had ever used OCs (WHO, 1992) and over the last few decades its incidence and mortality trends have been consistently more favourable in women than in males in North America and in most western European countries (Ries et al., 1991; La Vecchia et al., 1992). This may be due to a healthier dietary and lifestyle pattern in women, but also to a potential protective effect of exposure to (exogenous) female hormones in women. Such an effect of female sex hormones on colorectal carcinogenesis is biologically plausible, as they influence hepatic cholesterol metabolism and bile production (McMichael and Potter, 1980), and steroid hormone receptors have been found in colorectal cancers and normal colonic mucosa (Singh et al., 1993; Hendrickse et al., 1993). Furthermore, an inverse relationship between parity and colorectal cancer risk (Potter and McMichael, 1983), as well as an increased incidence of colorectal cancer in nuns (Fraumeni et al., 1969), has been reported.Several cohort and case-control studies have investigated reproductive factors and colorectal cancer in women (La Vecchia and Franceschi, 1991;Potter et al., 1993) but only few have considered use of oral contraceptives and/or hormone replacement therapy (Potter and McMichael, 1983;Wu et al., 1987; Adami et al., 1989;Chute et al., 1991;Bostick et al., 1994;Weiss et al., 1981;Rosenberg et al., 1987; Davis et al., 1989;Furner et al., 1989;Peters et al., 1990; Kune et al., 1990;Wu-Williams et al., 1991; Gerhardsson de Verdier and London, 1992;Newcomb and Storer, 1995;Jacobs et al., 1994;Risch and Howe, 1995;Calle et al., 1995; Folsom et al., 1995). Among these, two studies have reported some (although inconsistent) increased risk of colorectal cancer among women who had used oral contraceptives (OCs) (Weiss et al., 1981; Kune et al., 1990), and one showed a moderate protection (Potter and McMichael, 1983). In six studies an inverse relationship was observed for hormone replacement therapy (HRT) (Chute et al., 1991;Furner et al., 1989; Gerhardson de Verdier and London, 1992;Jacobs et al., 1994;Newcomb and Storer, 1995;Calle et al., 1995). In summary, most evidence suggests that OC and HRT use do not increase the risk of colorectal cancer, and some data even indicate a possible protective effect of HRT. Given the widespread use of OCs and HRT in developed countries, it is a major public health issue to further elucidate this relationship. Thus, this investigation was aimed at assessing the relationship between OC and HRT use and colorectal cancer, using data from a case -control study c...