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

This study is not yet open for participant recruitment.
Verified April 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01602770
First received: May 18, 2012
Last updated: April 14, 2014
Last verified: April 2014
  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).


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®

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]
  • Continuation rate, as proportion of patients still using Qlaira [ Time Frame: After 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: May 2014
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: August 2016 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602770

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
Mexico
Not yet recruiting
Many Locations, Mexico
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01602770     History of Changes
Other Study ID Numbers: 16233, QL1210MX
Study First Received: May 18, 2012
Last Updated: April 14, 2014
Health Authority: Mexico: Federal Commission for Protection Against Health Risks (COFEPRIS)

Keywords provided by Bayer:
Oral contraceptives
Adverse events
Safety profile
Contraceptive Agents

Additional relevant MeSH terms:
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014