Yasmin Post Marketing Surveillance

November 10, 2015 updated by: Bayer

Yasmin Regulatory Post Marketing Surveillance

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

777

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Korean women who need oral contraceptive

Description

Inclusion Criteria:

  • Women who need oral contraceptive

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and efficacy in real practice
Time Frame: After 6 cycle of treatment
After 6 cycle of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Demography
Time Frame: At initial visit
At initial visit
Medical History
Time Frame: At initial visit
At initial visit
Administration period of Yasmin
Time Frame: After 6 cycle of treatment or at the point of withdrawan
After 6 cycle of treatment or at the point of withdrawan
Patient's compliance
Time Frame: After 6 cycle of treatment or at the point of withdrawan
After 6 cycle of treatment or at the point of withdrawan
Adverse Event / Serious AE collection
Time Frame: At point of the occurence
At point of the occurence

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

June 17, 2009

First Submitted That Met QC Criteria

June 17, 2009

First Posted (Estimate)

June 18, 2009

Study Record Updates

Last Update Posted (Estimate)

November 11, 2015

Last Update Submitted That Met QC Criteria

November 10, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14339
  • YA0510KR (Other Identifier: company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Clinical Trials on EE30/DRSP (Yasmin, BAY86-5131)

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
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