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

NCT01602770 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2019-04-29

No results posted yet for this study

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).

Conditions

  • Contraception

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-06
Primary Completion
2017-05-17
Completion
2017-10-31

Countries

  • Mexico

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01602770 on ClinicalTrials.gov