Yasmin Post Marketing Surveillance

Contraception Clinical Trial

Official title:

Yasmin Regulatory Post Marketing Surveillance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00923572
• Other study ID #: 14339
• Secondary ID: YA0510KR
• Status: Completed
• Phase: N/A
• First received: June 17, 2009
• Last updated: November 10, 2015
• Start date: December 2007
• Est. completion date: August 2013

Study information

• Verified date: November 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 777
• Est. completion date: August 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women who need oral contraceptive

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Contraception

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and efficacy in real practice		After 6 cycle of treatment	Yes
Secondary	Demography		At initial visit	No
Secondary	Medical History		At initial visit	No
Secondary	Administration period of Yasmin		After 6 cycle of treatment or at the point of withdrawan	No
Secondary	Patient's compliance		After 6 cycle of treatment or at the point of withdrawan	No
Secondary	Adverse Event / Serious AE collection		At point of the occurence	Yes

External Links

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