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| ID | Type | Description | Link |
|---|---|---|---|
| QL1210MX | Other Identifier | company internal |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EV/DNG (Qlaira, BAY86-5027) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety variables will be summarized using descriptive statistics based on adverse events collection | After 24 months | |
| Continuation rate, as proportion of patients still using Qlaira | After 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reasons for discontinuation related or unrelated to adverse events | After 24 months | |
| Patient satisfaction with Qlaira | After 24 months |
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Inclusion Criteria:
Healthy women of reproductive age who are:
Exclusion Criteria:
Women with risk parameters of arterial or venous thrombotic diseases such as:
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Cohort of healthy women of reproductive age currently Qlaira users from selected obstetrics and gynecology (Ob/Gyn) primary care clinics
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Mexico |
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