Trial Condition(s):

Contraceptives, Oral

Non-interventional study on oral contraception not containing ethinylestradiol (EE) to assess continuation rates and satisfaction

Bayer Identifier:

15217

ClinicalTrials.gov Identifier:

NCT01200186

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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 Summary

Enrollment Goal
3258
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Natazia/Qlaira (EV/DNG, BAY86-5027)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, France

Status
Completed
 
Locations

Investigative Site

Many Locations, United Kingdom

Status
Completed
 
Locations

Investigative Site

Many Locations, Sweden

Status
Completed
 
Locations

Investigative Site

Many Locations, Hungary

Status
Completed
 
Locations

Investigative Site

Many Locations, Greece

Status
Completed
 
Locations

Investigative Site

Many Locations, Slovakia

Status
Completed
 
Locations

Investigative Site

Many Locations, Germany

Status
Completed
 
Locations

Investigative Site

Many Locations, Italy

Status
Completed
 
Locations

Investigative Site

Many Locations, Czech Republic

Status
Completed
 
Locations

Investigative Site

Many locations, Israel

Status
Completed
 
Locations

Investigative Site

Many Locations, Russia

Status
Completed
 

Trial Design