NCT01200186

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,258 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Contraceptives, Oral

Interventions

Type	Name	Description
DRUG	EV/DNG (Qlaira, BAY86-5027)	At the discretion of the attending physician
DRUG	Progestin Only Pills	At the discretion of the attending physician

Timeline

• Start date: 2010-10-01
• Primary completion: 2014-02-01
• Completion: 2014-10-01
• First posted: 2010-09-13
• Last updated: 2015-10-16

Locations

11 sites across 11 countries: Czechia, France, Germany, Greece, Hungary, Israel, Italy, Russia, Slovakia, Sweden, United Kingdom