Clinical trial NCT01200186: Non-interventional Study on Oral Contraception Not Containing Ethinylestradiol (EE) to Assess Continuation Rates and Satisfaction
Official title: Non-interventional Study on Oral Contraception Not Containing Ethinylestradiol (EE) to Assess Continuation Rates and Satisfaction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraceptives, Oral
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-09-13
Enrollment: 3258
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women in gynecological practice

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.


Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome measure will be time-to-event for discontinuation due to bleeding irregularities.
timeFrame: up to 12 Months
Secondary outcomes:
measure: Time to event for discontinuation due to reasons other than bleeding irregularities
timeFrame: Month 3-5
measure: Time to event for discontinuation due to reasons other than bleeding irregularities
timeFrame: Month 6-12
measure: Number of intracyclic bleeding
timeFrame: Month 3-5
measure: Number of intracyclic bleeding
timeFrame: Month 6-12
measure: Number of heavy and/or prolonged bleeding
timeFrame: Month 3-5
measure: Number of heavy and/or prolonged bleeding
timeFrame: Month 6-12
measure: Number of unintended pregnancies
timeFrame: Month 3-5
measure: Number of unintended pregnancies
timeFrame: Month 6-12
measure: 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
timeFrame: Month 3-5
measure: 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
timeFrame: Month 6-12
measure: Global assessment of well-being and satisfaction
timeFrame: Month 3-5
measure: Global assessment of well-being and satisfaction
timeFrame: Month 6-12
measure: Adverse events (AEs) at any time point, whether or not related to the therapy or reference therapy
timeFrame: up to 12 Months
Other outcomes:
Locations:
city: Many Locations
country: Czech Republic
city: Many Locations
country: France
city: Many Locations
country: Germany
city: Many Locations
country: Greece
city: Many Locations
country: Hungary
city: Many locations
country: Israel
city: Many Locations
country: Italy
city: Many Locations
country: Russian Federation
city: Many Locations
country: Slovakia
city: Many Locations
country: Sweden
city: Many Locations
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: