Qlaira® Post-authorization Safety Study Related to Most Common Adverse Events in Mexican Women Who Wish to Avoid Pregnancy
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).
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Prospective, Non-interventional, 2-year Post-authorization Safety Study for QLAIRA®|
- Safety variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: After 24 months ] [ Designated as safety issue: Yes ]
- Continuation rate, as proportion of patients still using Qlaira [ Time Frame: After 24 months ] [ Designated as safety issue: Yes ]
- Reasons for discontinuation related or unrelated to adverse events [ Time Frame: After 24 months ] [ Designated as safety issue: Yes ]
- Patient satisfaction with Qlaira [ Time Frame: After 24 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Drug: EV/DNG (Qlaira, BAY86-5027)
Qlaira is taken daily continously with no pause between cycles in a four-phasic dose regimen, making up a treatment of up to 28 days. The first two tablets contain 3 mg Estradiol Valerate (E2V). The next five tablets include 2 mg E2V and 2 mg Dienogest (DNG) followed by 17 tablets with 2 mg E2V and 3 mg DNG. Finally, there are two tablets with 1 mg E2V and two placebo tablets.