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Yasmin Post Marketing Surveillance
This study is currently recruiting participants.
Verified by Bayer, February 2010
First Received: June 17, 2009   Last Updated: February 4, 2010   History of Changes
Sponsor: Bayer
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00923572
  Purpose

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


Condition Intervention Phase
Contraception
 Drug: Yasmin (EE30/DRSP, BAY86-5131)
 Phase IV

Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Yasmin Regulatory Post Marketing Surveillance

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Safety and efficacy evaluation in real practice [ Time Frame: after administration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Demography [ Time Frame: Before administration ] [ Designated as safety issue: No ]
  • Medical History/Background [ Time Frame: Before administration ] [ Designated as safety issue: No ]
  • Dose [ Time Frame: At point of administration ] [ Designated as safety issue: No ]
  • Concomitant medication [ Time Frame: At point of administration ] [ Designated as safety issue: No ]
  • Facility [ Time Frame: At point of administration ] [ Designated as safety issue: No ]
  • Diagnosis [ Time Frame: After administration ] [ Designated as safety issue: No ]
  • SAE/AE [ Time Frame: At the point of the occurence ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

Biospecimen Description:

n.a


Estimated Enrollment: 900
Study Start Date: March 2008
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Yasmin (EE30/DRSP, BAY86-5131)
Patients in daily life clinical practice treatment receiving Yasmin according to indication on the label.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Korean women who need oral contraceptive

Criteria

Inclusion Criteria:

  • Women who need oral contraceptive

Exclusion Criteria:

  • Patient who belongs to contraindication listed on the product label.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00923572

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
Korea, Republic of
Recruiting
Many Locations, Korea, Republic of
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site
Click here to find results for studies related to marketed products  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bayer healthcare Pharmaceutical Inc. ( Medical Director )
Study ID Numbers: 14339, YA0510KR
Study First Received: June 17, 2009
Last Updated: February 4, 2010
ClinicalTrials.gov Identifier: NCT00923572     History of Changes
Health Authority: South Korea: Korean Food and Drug Administration

Keywords provided by Bayer:
Oral contraceptive

ClinicalTrials.gov processed this record on February 08, 2010



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