Qlaira Post-authorization Safety Study Related to Most Common Adverse Events in Mexican Women Who Wish to Avoid Pregnancy

Overview

Qlaira is a combined oral contraceptive (COC) containing dienogest/estradiol valerate being the first oral contraceptive delivering estradiol. It has been recently approved in Mexico. To evaluate the clinical profile of this drug combination under routine medical condition, a post-authorization safety study required by Mexican Health Authorities will be conducted in Mexican women. The study will be performed as a descriptive study, no hypothesis will be tested. The cohort consists of 300 new users (first-ever users or switchers) of Qlaira under routine medical conditions. Subjects should provide all necessary information on health-related events or changes in health status during Qlaira use. Primary variable will be the incidence of Adverse Events (AE) at any time point, whether or not related to Qlaira during at least 2 years of observation. In order to comply with the criteria of a non-interventional study, women only will be informed about the study, asked to participate and included in the study after Qlaira has been prescribed. Study patients follow-up will be done in accordance with common clinical practice as described at Mexican Official Guidelines for prescription of Family Planning Methods (NOM 005-SSA2-1993).

Conditions

Interventions