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Yasmin Post Marketing Surveillance

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ClinicalTrials.gov Identifier: NCT00923572
Recruitment Status : Completed
First Posted : June 18, 2009
Last Update Posted : November 11, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

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)

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
Primary Completion Date : May 2013
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

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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.

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 ClinicalTrials.gov identifier (NCT number): NCT00923572


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00923572     History of Changes
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:
Drospirenone and ethinyl estradiol combination
Reproductive Control Agents
Physiological Effects of Drugs