Yasmin Post Marketing Surveillance

Completed

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

• Registration Number: NCT00923572
• Lead Sponsor: Bayer

Brief Summary

The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2009-06-17
• Study First Submitted QC: 2009-06-17
• Study First Posted: 2009-06-18
• Primary Completion: 2013-05
• Study Completion: 2013-08
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-10
• Last Update Posted: 2015-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 777

Inclusion Criteria

• Women who need oral contraceptive

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Exclusion Criteria

• Patient who belongs to contraindication listed on the product label.

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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)	-

Primary Outcome Measures

Name	Time	Method
Safety and efficacy in real practice	After 6 cycle of treatment

Secondary Outcome Measures

Name	Time	Method
Demography	At initial visit
Medical History	At initial visit
Administration period of Yasmin	After 6 cycle of treatment or at the point of withdrawan
Adverse Event / Serious AE collection	At point of the occurence
Patient's compliance	After 6 cycle of treatment or at the point of withdrawan