Qlaira Post-authorization Safety Study Related to Most Common Adverse Events in Mexican Women Who Wish to Avoid Pregnancy
Status:
Completed
Trial end date:
2017-10-31
Target enrollment:
Participant gender:
Summary
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).