Contraceptives, Oral
Conditions
Brief summary
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.
Interventions
At the discretion of the attending physician
DRUGProgestin Only Pills
At the discretion of the attending physician
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be time-to-event for discontinuation due to bleeding irregularities. | up to 12 Months |
Secondary
| Measure | Time frame |
|---|---|
| Number of intracyclic bleeding | Month 3-5 |
| Number of heavy and/or prolonged bleeding | Month 3-5 |
| Number of unintended pregnancies | Month 3-5 |
| Time to event for discontinuation due to reasons other than bleeding irregularities | Month 3-5 |
| Global assessment of well-being and satisfaction | Month 3-5 |
| Adverse events (AEs) at any time point, whether or not related to the therapy or reference therapy | up to 12 Months |
| 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 |
Countries
Czechia, France, Germany, Greece, Hungary, Israel, Italy, Russia, Slovakia, Sweden, United Kingdom
Outcome results
None listed