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Qlaira Post-authorization Safety Study Related to Most Common Adverse Events in Mexican Women Who Wish to Avoid Pregnancy

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 by Bayer
Information provided by (Responsible Party):
Bayer Identifier:
First received: May 18, 2012
Last updated: September 8, 2017
Last verified: September 2017

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).

Condition Intervention
Contraception Drug: EV/DNG (Qlaira, BAY86-5027)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Non-interventional, 2-year Post-authorization Safety Study for QLAIRA®

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Safety variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: After 24 months ]
  • Continuation rate, as proportion of patients still using Qlaira [ Time Frame: After 24 months ]

Secondary Outcome Measures:
  • Reasons for discontinuation related or unrelated to adverse events [ Time Frame: After 24 months ]
  • Patient satisfaction with Qlaira [ Time Frame: After 24 months ]

Estimated Enrollment: 300
Actual Study Start Date: July 27, 2015
Estimated Study Completion Date: July 31, 2018
Estimated Primary Completion Date: January 15, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 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.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01602770

Contact: Bayer Clinical Trials Contact

Many Locations, Mexico
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT01602770     History of Changes
Other Study ID Numbers: 16233
QL1210MX ( Other Identifier: company internal )
Study First Received: May 18, 2012
Last Updated: September 8, 2017

Keywords provided by Bayer:
Oral contraceptives
Adverse events
Safety profile
Contraceptive Agents processed this record on September 20, 2017