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

Bayer

Status: Completed

Conditions: Contraceptives, Oral

Treatments: Drug: EV/DNG (Qlaira, BAY86-5027); Drug: Progestin Only Pills

Study type: Observational

Funder types: Industry

Identifiers

NCT01200186

15217

QL0901 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 3,258 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

3,258 participants in 2 patient groups

Group 1

Treatment:

Drug: EV/DNG (Qlaira, BAY86-5027)

Group 2

Treatment:

Drug: Progestin Only Pills