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

ID: NCT01602770
Status: Recruiting
Phase: N/A
Start Date: July 27, 2015
First Submitted: May 18, 2012
Last Updated: February 13, 2018
Results: N/A
Organization: Bayer
Sponsors & Collaborators: Bayer
Location: Mexico
Conditions: Contraception
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Study Description

Brief 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).

Detailed Description

Condition or disease Intervention/treatment Phase

Contraception

Drug: EV/DNG (Qlaira, BAY86-5027)
Other Names
N/A

Tracking Information

First Submitted DateMay 18, 2012
Last Update Posted DateFebruary 13, 2018
Actual Start DateJuly 27, 2015
Anticipated Completion DateJuly 31, 2018
Actual Primary Completion DateApril 14, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

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

  • Safety variables will be summarized using descriptive statistics based on adverse events collection [Time Frame: After 24 months]

Original Primary Outcome Measures

Not Available

Current 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]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleQlaira Post-authorization Safety Study Related to Most Common Adverse Events in Mexican Women Who Wish to Avoid Pregnancy
Official TitleProspective, Non-interventional, 2-year Post-authorization Safety Study for QLAIRA®
Brief 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).

Detailed Description

Study TypeObservational
Study PhaseN/A
Estimated Enrollment
300
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Contraception
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodNon-Probability Sample
Study PopulationCohort of healthy women of reproductive age currently Qlaira users from selected obstetrics and gynecology (Ob/Gyn) primary care clinics
Intervention
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.

Other Names
Study Groups/Cohorts
Group 1
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.

Study Arms
Group 1
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.
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.

Arm Intervention/Treatment
Group 1
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.
Drug : EV/DNG (Qlaira, BAY86-5027)

Recruitment Information

Recruitment Status:Recruiting
Enrollment300
Completion DateJuly 31, 2018
Eligibility 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
GenderFemale
Age18 Years to 40 Years
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
Mexico

Administrative Information

NCT Number:NCT01602770
Other Study ID Numbers
16233
QL1210MX
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Bayer
Collaborators
Not Available
Investigators
Study Director
Bayer Study Director
Bayer