OBJECTIVES Women's choices of contraceptive method are largely affected by the safety and efficacy of contraceptive methods as well as by change in women's quality of life. The SEC-QoL questionnaire has been recently elaborated and validated in fertile women users of contraceptive methods in Spanish population. METHODS  Observational, prospective, multicentre study involving 41 contraceptive gynaecologist and GPs. Three patients’ groups were identified at baseline visit: 1) Fertile women users of efficacy contraceptive methods; 2) Fertile women users of non-efficacy contraceptive methods but will begin to use efficacy contraceptive methods; 3) Fertile women user of non efficacy contraceptive methods. All women were ≥18 years. Follow up and final visit was at 4 month since baseline visit. Socio-demographic and clinical information was gathered. The specific questionnaire SEC-QoL (19 items) was administered. RESULTS  A total of 453 women were included. Mean (SD) age was 29.3 (7.7). The most frequently used contraceptive methods were: pill (43% A), inconsistent condom (79% B and 63% C). The factorial analysis confirmed a total of 5 dimensions (social/daily activities, menstrual and breast symptoms, psychological and sexual dimension). HRQoL according to SEC-QoL score was higher (better HRQoL) in group A (59.2) than in group B (46.6) and C (49.8) (p<0.01). Considering A and B groups, HRQoL (SEC-QoL total score) was better in women with low bleeding intensity, low pain, and low androgenic and breast symptoms (p<0.01). No differences were shown according to days between menstrual intervals. Hormonal contraceptive method users showed better HRQoL (61.2) than women using other method (53.3) (p<0.05). Both, in group A and B an increase in HRQoL was shown in the final visit, being statistically significant in all dimensions of SEC-QoL questionnaire in Group B (p<0.05). CONCLUSIONS  SEC-QoL is a valid and reliable specific measure to assess HRQOL in fertile women users of contraceptive methods, in routine clinical practice and clinical studies.