COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Yasmin Post Marketing Surveillance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00923572
Recruitment Status : Completed
First Posted : June 18, 2009
Last Update Posted : November 11, 2015
Information provided by (Responsible Party):

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

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

Layout table for study information
Study Type : Observational
Actual Enrollment : 777 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Yasmin Regulatory Post Marketing Surveillance
Study Start Date : December 2007
Actual Primary Completion Date : May 2013
Actual Study Completion Date : August 2013

Group/Cohort Intervention/treatment
Group 1 Drug: EE30/DRSP (Yasmin, BAY86-5131)
Patients in daily life clinical practice treatment receiving Yasmin according to indication on the label.

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Korean women who need oral contraceptive

Inclusion Criteria:

  • Women who need oral contraceptive

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00923572

Layout table for location information
Korea, Republic of
Many Locations, Korea, Republic of
Sponsors and Collaborators
Layout table for investigator information
Study Director: Bayer Study Director Bayer
Layout table for additonal information
Responsible Party: Bayer Identifier: NCT00923572    
Other Study ID Numbers: 14339
YA0510KR ( Other Identifier: company internal )
First Posted: June 18, 2009    Key Record Dates
Last Update Posted: November 11, 2015
Last Verified: November 2015
Keywords provided by Bayer:
Oral contraceptive
Additional relevant MeSH terms:
Layout table for MeSH terms
Drospirenone and ethinyl estradiol combination
Reproductive Control Agents
Physiological Effects of Drugs