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Clinical Trials/NCT00923572
NCT00923572
Completed
Not Applicable

Yasmin Regulatory Post Marketing Surveillance

Bayer0 sites777 target enrollmentDecember 2007

Overview

Phase
Not Applicable
Intervention
EE30/DRSP (Yasmin, BAY86-5131)
Conditions
Contraception
Sponsor
Bayer
Enrollment
777
Primary Endpoint
Safety and efficacy in real practice
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
December 2007
End Date
August 2013
Last Updated
10 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Bayer
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Women who need oral contraceptive

Exclusion Criteria

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

Arms & Interventions

Group 1

Intervention: EE30/DRSP (Yasmin, BAY86-5131)

Outcomes

Primary Outcomes

Safety and efficacy in real practice

Time Frame: After 6 cycle of treatment

Secondary Outcomes

  • Medical History(At initial visit)
  • Demography(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)

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