Non-interventional Study on Oral Contraception Not Containing Ethinylestradiol (EE) to Assess Continuation Rates and Satisfaction

Study Overview
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Brief Summary
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Prospective, non-interventional, multi-center study. Each subject will be followed for up to twelve months during the treatment with oral hormonal contraceptives(Qlaira ® or a Progestin Only Pill). For each subject demographic data and medical history will be documented at Visit 1: (Baseline). Bleeding profile, subjective assessment of study treatment (satisfaction and wellbeing) and adverse events including unintended pregnancies will be documented at Visit 2 (Month 3-5) and Visit 3 (Month 6-12). Data audit/monitoring will be done.

Official Title
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Non-interventional Study on Oral Contraception Not Containing Ethinylestradiol (EE) to Assess Continuation Rates and Satisfaction

Conditions
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Contraceptives, Oral

Intervention / Treatment
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* Drug: EV/DNG (Qlaira, BAY86-5027)
* Drug: Progestin Only Pills


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women between 18-50 years Women who used ethinylestradiol containing oral contraceptives for at least the three preceding months before the study Women who decided to start Qlaira® or a Progestin Only Pill. The prescription of the hormonal contraceptive is made at the discretion of the attending physician and has to be documented Exclusion Criteria: Contraindications and warnings of the respective Summary of Product Characteristics (Qlaira® or Progestin Only Pill) Women who are breast-feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: EV/DNG (Qlaira, BAY86-5027)<br>* At the discretion of the attending physician<br>|
| Group 2<br> | Drug: Progestin Only Pills<br>* At the discretion of the attending physician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure will be time-to-event for discontinuation due to bleeding irregularities. |  | up to 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to event for discontinuation due to reasons other than bleeding irregularities |  | Month 3-5 | 
| Time to event for discontinuation due to reasons other than bleeding irregularities |  | Month 6-12 | 
| Number of intracyclic bleeding |  | Month 3-5 | 
| Number of intracyclic bleeding |  | Month 6-12 | 
| Number of heavy and/or prolonged bleeding |  | Month 3-5 | 
| Number of heavy and/or prolonged bleeding |  | Month 6-12 | 
| Number of unintended pregnancies |  | Month 3-5 | 
| Number of unintended pregnancies |  | Month 6-12 | 
| Discontinuation rate for the following reasons: Occasional absent or persistent absent withdrawal bleeding , intracyclic bleeding, heavy and/or prolonged bleeding, other medical reasons, non-medical reasons |  | Month 3-5 | 
| Discontinuation rate for the following reasons: Occasional absent or persistent absent withdrawal bleeding , intracyclic bleeding, heavy and/or prolonged bleeding, other medical reasons, non-medical reasons |  | Month 6-12 | 
| Global assessment of well-being and satisfaction |  | Month 3-5 | 
| Global assessment of well-being and satisfaction |  | Month 6-12 | 
| Adverse events (AEs) at any time point, whether or not related to the therapy or reference therapy |  | up to 12 Months |