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: October 29, 2013
Last verified: October 2013
  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

Resource links provided by NLM:


Further study details as provided by Bayer:

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

Secondary Outcome Measures:
  • Demography [ Time Frame: At initial visit ] [ Designated as safety issue: No ]
  • Medical History [ Time Frame: At initial visit ] [ Designated as safety issue: No ]
  • Administration period of Yasmin [ Time Frame: After 6 cycle of treatment or at the point of withdrawan ] [ Designated as safety issue: No ]
  • Patient's compliance [ Time Frame: After 6 cycle of treatment or at the point of withdrawan ] [ Designated as safety issue: No ]
  • Adverse Event / Serious AE collection [ Time Frame: At point of the occurence ] [ Designated as safety issue: Yes ]

Enrollment: 777
Study Start Date: March 2008
Study Completion Date: August 2013
Primary Completion Date: February 2011 (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
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

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00923572     History of Changes
Other Study ID Numbers: 14339, YA0510KR
Study First Received: June 17, 2009
Last Updated: October 29, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Bayer:
Oral contraceptive

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

ClinicalTrials.gov processed this record on April 21, 2014