check_circleStudy Completed

Contraception

Bayer Identifier:

14339

ClinicalTrials.gov Identifier:

NCT00923572

EudraCT Number:

Not Available

EU CT Number:

Not Available
Yasmin Post Marketing Surveillance

Trial purpose

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

Key Participants Requirements

Sex

Female

Age

18 - N/A
  • - Women who need oral contraceptive
  • - Patient who belongs to contraindication listed on the product label.

Trial summary

Enrollment Goal
777
Trial Dates
December 2007 - August 2013
Phase
N/A
Could I Receive a placebo
No
Products
Yasmin (EE30/DRSP, BAY86-5131)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Korea, Republic Of

Primary Outcome

  • Safety and efficacy in real practice
    date_rangeTime Frame:
    After 6 cycle of treatment
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Demography
    date_rangeTime Frame:
    At initial visit
    enhanced_encryption
    Safety Issue:
    No
  • Medical History
    date_rangeTime Frame:
    At initial visit
    enhanced_encryption
    Safety Issue:
    No
  • Administration period of Yasmin
    date_rangeTime Frame:
    After 6 cycle of treatment or at the point of withdrawan
    enhanced_encryption
    Safety Issue:
    No
  • Patient's compliance
    date_rangeTime Frame:
    After 6 cycle of treatment or at the point of withdrawan
    enhanced_encryption
    Safety Issue:
    No
  • Adverse Event / Serious AE collection
    date_rangeTime Frame:
    At point of the occurence
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    Safety Issue:
    Yes

Trial design

Yasmin regulatory Post Marketing Surveillance
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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