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Completed

NCT Number: NCT01602770

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

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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Key information

Conditions

Contraception

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Multiple Locations, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Safety variables will be summarized using descriptive statistics based on adverse events collection

    Time frame: After 24 months

  2. Continuation rate, as proportion of patients still using Qlaira

    Time frame: After 24 months

Secondary outcomes

  1. Reasons for discontinuation related or unrelated to adverse events

    Time frame: After 24 months

  2. Patient satisfaction with Qlaira

    Time frame: After 24 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Prospective, Non-interventional, 2-year Post-authorization Safety Study for QLAIRA®

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 21, 2012
Registry last updated
Apr 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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