NCT00923572

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
777

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 18, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

November 11, 2015

Status Verified

November 1, 2015

Enrollment Period

5.4 years

First QC Date

June 17, 2009

Last Update Submit

November 10, 2015

Conditions

Contraception

Keywords

Oral contraceptive

Outcome Measures

Primary Outcomes (1)

  • Safety and efficacy in real practice

    After 6 cycle of treatment

Secondary Outcomes (5)

  • Demography

    At initial visit

  • Medical History

    At initial visit

  • Administration period of Yasmin

    After 6 cycle of treatment or at the point of withdrawan

  • Patient's compliance

    After 6 cycle of treatment or at the point of withdrawan

  • Adverse Event / Serious AE collection

    At point of the occurence

Study Arms (1)

Group 1

Drug: EE30/DRSP (Yasmin, BAY86-5131)

Interventions

EE30/DRSP (Yasmin, BAY86-5131)DRUG

Patients in daily life clinical practice treatment receiving Yasmin according to indication on the label.

Group 1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Korean women who need oral contraceptive

You may qualify if:

  • Women who need oral contraceptive

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, South Korea

Location

MeSH Terms

Interventions

drospirenone and ethinyl estradiol combination

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2009

First Posted

June 18, 2009

Study Start

December 1, 2007

Primary Completion

May 1, 2013

Study Completion

August 1, 2013

Last Updated

November 11, 2015

Record last verified: 2015-11

Locations

KR(1)