Clinical trial NCT01602770: Qlaira Post-authorization Safety Study Related to Most Common Adverse Events in Mexican Women Who Wish to Avoid Pregnancy
Official title: Prospective, Non-interventional, 2-year Post-authorization Safety Study for QLAIRA®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Keywords: Oral contraceptives
Adverse events
Safety profile
Contraceptive Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-05-21
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort of healthy women of reproductive age currently Qlaira users from selected obstetrics and gynecology (Ob/Gyn) primary care clinics

Brief 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).


Eligibility criteria: Inclusion Criteria:

Healthy women of reproductive age who are:

* Seeking fertility control with oral contraception at least for one year
* Able to go back to medical office on regular basis

Exclusion Criteria:

Women with risk parameters of arterial or venous thrombotic diseases such as:

* Smoke, if over age 35
* Deep vein thrombosis or pulmonary embolism, now or in the past
* Cerebrovascular disease
* Coronary artery disease
* Thrombogenic valvular or thrombogenic rhythm diseases of the heart
* Inherited or acquired hypercoagulopathies
* Uncontrolled hypertension
* Diabetes with vascular disease
* Headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35
* Undiagnosed abnormal genital bleeding
* Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past
* Liver tumors, benign or malignant, or liver disease
* Pregnancy

Primary outcomes:
measure: Safety variables will be summarized using descriptive statistics based on adverse events collection
timeFrame: After 24 months
measure: Continuation rate, as proportion of patients still using Qlaira
timeFrame: After 24 months
Secondary outcomes:
measure: Reasons for discontinuation related or unrelated to adverse events
timeFrame: After 24 months
measure: Patient satisfaction with Qlaira
timeFrame: After 24 months
Other outcomes:
Locations:
city: Multiple Locations
country: Mexico
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: