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Yasmin Post Marketing Surveillance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00923572
First received: June 17, 2009
Last updated: November 10, 2015
Last verified: November 2015
  Purpose
The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice.

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Yasmin Regulatory Post Marketing Surveillance

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Safety and efficacy in real practice [ Time Frame: After 6 cycle of treatment ]

Secondary Outcome Measures:
  • Demography [ Time Frame: At initial visit ]
  • Medical History [ Time Frame: At initial visit ]
  • Administration period of Yasmin [ Time Frame: After 6 cycle of treatment or at the point of withdrawan ]
  • Patient's compliance [ Time Frame: After 6 cycle of treatment or at the point of withdrawan ]
  • Adverse Event / Serious AE collection [ Time Frame: At point of the occurence ]

Enrollment: 777
Study Start Date: December 2007
Study Completion Date: August 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: EE30/DRSP (Yasmin, 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   (Adult, Senior)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00923572

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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00923572     History of Changes
Other Study ID Numbers: 14339
YA0510KR ( Other Identifier: company internal )
Study First Received: June 17, 2009
Last Updated: November 10, 2015

Keywords provided by Bayer:
Oral contraceptive

Additional relevant MeSH terms:
Drospirenone and ethinyl estradiol combination
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 23, 2017