check_circleStudy Completed

Contraception

Bayer Identifier:

16233

ClinicalTrials.gov Identifier:

NCT01602770

EudraCT Number:

Not Available

EU CT Number:

Not Available
Qlaira post-authorization safety study related to most common adverse events in Mexican women who wish to avoid pregnancy

Trial purpose

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).

Key Participants Requirements

Sex

Female

Age

18 - 40 Years
  • 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

  • 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

Trial summary

Enrollment Goal
1
Trial Dates
February 2015 - October 2017
Phase
Phase 4
Could I Receive a placebo
No
Products
Natazia/Qlaira (EV/DNG, BAY86-5027)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Mexico

Primary Outcome

  • Safety variables will be summarized using descriptive statistics based on adverse events collection
    date_rangeTime Frame:
    After 24 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Continuation rate, as proportion of patients still using Qlaira
    date_rangeTime Frame:
    After 24 months
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Reasons for discontinuation related or unrelated to adverse events
    date_rangeTime Frame:
    After 24 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Patient satisfaction with Qlaira
    date_rangeTime Frame:
    After 24 months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Prospective, non-interventional, 2-year post-authorization safety study for QLAIRA®
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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