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Non-interventional Study on Oral Contraception Not Containing Ethinylestradiol (EE) to Assess Continuation Rates and Satisfaction
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.
Details
| Lead sponsor | Bayer |
|---|---|
| Status | COMPLETED |
| Enrolment | 3258 |
| Start date | 2010-10 |
| Completion | 2014-10 |
Conditions
- Contraceptives, Oral
Interventions
- EV/DNG (Qlaira, BAY86-5027)
- Progestin Only Pills
Primary outcomes
- The primary outcome measure will be time-to-event for discontinuation due to bleeding irregularities. — up to 12 Months
Countries
Czechia, France, Germany, Greece, Hungary, Israel, Italy, Russia, Slovakia, Sweden, United Kingdom