Yasmin Post Marketing Surveillance - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00923572

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:	June 2013
Estimated Primary Completion Date:	January 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

Study Population

Korean women who need oral contraceptive

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

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

Contacts

Contact: Bayer Clinical Trials Contact

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:

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 14, 2012
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, 2012