Safety of norethisterone enanthate and estradiol valerate as a contraceptive method in Peru

López L.; Vicuña R.; Aguilar S.; Delgado C.; Benilde-Corser M.; Rosas Ma.M.; del Rosario Forero Ma. · Revista Chilena de Obstetricia y Ginecologia (2024) · DOI: 10.24875/rechog.23000096

Resumen

Introduction: The combination of norethisterone enanthate (50mg), estradiol valerate (5mg) (Mesigyna®) is a contraceptive with extensive real-life use. However, the use of contraceptives in Peru is below the regional average. Objective: Evaluate the safety profile of the combination of norethisterone enanthate (50 mg), estradiol valerate (5 mg) (Mesigyna®), as a contraceptive method in clinical practice in Peru. Method: A prospective, observational, longitudinal study was conducted in women of childbearing age treated with Mesigyna®. Sociodemographic, drug, follow-up and safety variables were collected. Qualitative variables are reported in frequencies, and adverse events in incidence rates. Results: A total of 237 patients were eligible for the safety profile analysis, with a mean age of 26.5 ± 5.9 years. No pregnancies were reported. 32.9% (n = 78) of patients had 213 adverse events (95% CI: 26.97-39.29%), with an incidence of 285.7 per 100 person-years (95% CI: 248.8-326.6).The incidence of serious adverse events was 4.0 per 100 person-years (95% CI: 0.8-11.7). Conclusions: Mesigyna® is a contraceptive method with a favorable safety profile, according with the results observed in clinical studies of the molecule and in the literature.