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

Study Description

Brief Summary

Detailed Description

Condition or disease	Intervention/treatment	Phase
Contraception	Drug: EV/DNG (Qlaira, BAY86-5027) Other Names	N/A

Tracking Information

First Submitted Date	May 18, 2012
Last Update Posted Date	February 13, 2018
Actual Start Date	July 27, 2015
Anticipated Completion Date	July 31, 2018
Actual Primary Completion Date	April 14, 2018
Results First Submitted Date	N/A
Received Results Disposit Date	N/A

Current 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]

Original Primary Outcome Measures

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

Study Design

Brief Title	Qlaira Post-authorization Safety Study Related to Most Common Adverse Events in Mexican Women Who Wish to Avoid Pregnancy
Official Title	Prospective, 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 Type	Observational
Study Phase	N/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 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
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) 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.

Recruitment Information

Recruitment Status:	Recruiting
Enrollment	300
Completion Date	July 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
Gender	Female
Age	18 Years to 40 Years
Accepts Healthy Volunteers	No
Contacts	Bayer Clinical Trials Contact [email protected]
Listed Location Countries	Mexico

Administrative Information

NCT Number:	NCT01602770
Other Study ID Numbers	16233 QL1210MX
Has Data Monitoring Committee	No
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