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

Completed

• Conditions: Contraceptives, Oral
• Interventions: Drug: EV/DNG (Qlaira, BAY86-5027); Drug: Progestin Only Pills

• Registration Number: NCT01200186
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-13
• Study First Submitted QC: 2010-09-10
• Study First Posted: 2010-09-13
• Study Start: 2010-10
• Primary Completion: 2014-02
• Study Completion: 2014-10
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-15
• Last Update Posted: 2015-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3258

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

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Exclusion Criteria

• Contraindications and warnings of the respective Summary of Product Characteristics (Qlaira® or Progestin Only Pill)
• Women who are breast-feeding

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	EV/DNG (Qlaira, BAY86-5027)	-
Group 2	Progestin Only Pills	-

Primary Outcome Measures

Name	Time	Method
The primary outcome measure will be time-to-event for discontinuation due to bleeding irregularities.	up to 12 Months

Secondary Outcome Measures

Name	Time	Method
Number of heavy and/or prolonged bleeding	Month 6-12
Number of intracyclic bleeding	Month 6-12
Global assessment of well-being and satisfaction	Month 6-12
Adverse events (AEs) at any time point, whether or not related to the therapy or reference therapy	up to 12 Months
Time to event for discontinuation due to reasons other than bleeding irregularities	Month 6-12
Number of unintended pregnancies	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 reasons	Month 6-12