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:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, United Kingdom | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Sweden | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Hungary | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Greece | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Slovakia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Germany | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Italy | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Czech Republic | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Israel | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Russia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Non-interventional study on oral contraception not containing ethinylestradiol (EE) to assess continuation rates and satisfaction
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
Non-randomized
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- The primary outcome measure will be time-to-event for discontinuation due to bleeding irregularities.Timeframe: up to 12 Months
Secondary Outcome
- Time to event for discontinuation due to reasons other than bleeding irregularitiesTimeframe: Month 3-5
- Time to event for discontinuation due to reasons other than bleeding irregularitiesTimeframe: Month 6-12
- Number of intracyclic bleedingTimeframe: Month 3-5
- Number of intracyclic bleedingTimeframe: Month 6-12
- Number of heavy and/or prolonged bleedingTimeframe: Month 3-5
- Number of heavy and/or prolonged bleedingTimeframe: Month 6-12
- Number of unintended pregnanciesTimeframe: Month 3-5
- Number of unintended pregnanciesTimeframe: Month 6-12
- 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 reasonsTimeframe: Month 3-5
- 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 reasonsTimeframe: Month 6-12
- Global assessment of well-being and satisfactionTimeframe: Month 3-5
- Global assessment of well-being and satisfactionTimeframe: Month 6-12
- Adverse events (AEs) at any time point, whether or not related to the therapy or reference therapyTimeframe: up to 12 Months
Additional Information
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