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Yasmin Post Marketing Surveillance

This study is currently recruiting participants.
Verified May 2013 by Bayer
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00923572
First received: June 17, 2009
Last updated: May 17, 2013
Last verified: May 2013
History of Changes
  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:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

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 ]

Estimated Enrollment: 900
Study Start Date: March 2008
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 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
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

No publications provided

Responsible Party: Medical Director, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00923572     History of Changes
Other Study ID Numbers: 14339, YA0510KR
Study First Received: June 17, 2009
Last Updated: May 17, 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 May 23, 2013