Effects of Counseling on the Continuation Rates and Compliance for Newly Prescribed Oral Contraceptives (Yasmin® or Any Other Oral Contraceptives (OC)

Completed

• Conditions: Contraception
• Interventions: Drug: EE30/DRSP (Yasmin, BAY86-5131); Drug: Any other OC

• Registration Number: NCT00905684
• Lead Sponsor: Bayer

Brief Summary

This study is a prospective, company-sponsored, non-interventional cohort study of up to 5000 patients in European countries and countries in Middle East who are newly prescribed any available OC. Patients will be followed up approximately 6 months after initial visit. Selection of Study Population: Women can be enrolled after decision for treatment with Yasmin or any other OC has been made. Physicians should consult the full prescribing information for the respective OC before enrolling patients and familiarize themselves with the safety information in the product package label.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2009-05-18
• Study First Submitted QC: 2009-05-19
• Study First Posted: 2009-05-20
• Study Start: 2009-06
• Study Completion: 2011-12
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-06
• Last Update Posted: 2012-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5446

Inclusion Criteria

• Women who have been found eligible for OC use and have newly been prescribed an OC in accordance with the terms of the respective marketing authorization
• Starter (first-ever user of an OC) and switcher from another OC (incl. women with a history of OC use)

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Exclusion Criteria

• The contraindications and warnings of the Summary of Product Characteristics must be followed.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	EE30/DRSP (Yasmin, BAY86-5131)	-
Group 2	Any other OC	-

Primary Outcome Measures

Name	Time	Method
Analyses of continuation rates and compliance stratified by the subject's knowledge on the respective topics and time spent for counseling.	After 3 months and at end of study after approx. 6 months.

Secondary Outcome Measures

Name	Time	Method
Analyses stratified by baseline factors such as age group, presence or absence of cycle disorders, and history of oral contraceptive method will be performed as well.	After 3 months and after approx. 6 months.
Special attention will be paid to serious adverse events and unexpected or unlisted ADRs.	Over 12 months