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OpenTrials
Completed

NCT Number: NCT00923572

Yasmin Post Marketing Surveillance

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

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Key information

Conditions

Contraception

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Many Locations, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women who need oral contraceptive

Exclusion criteria

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

Treatment and study plan

EE30/DRSP (Yasmin, BAY86-5131)

Drug

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

Primary outcomes

  1. Safety and efficacy in real practice

    Time frame: After 6 cycle of treatment

Secondary outcomes

  1. Demography

    Time frame: At initial visit

  2. Medical History

    Time frame: At initial visit

  3. Administration period of Yasmin

    Time frame: After 6 cycle of treatment or at the point of withdrawan

  4. Patient's compliance

    Time frame: After 6 cycle of treatment or at the point of withdrawan

  5. Adverse Event / Serious AE collection

    Time frame: At point of the occurence

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Yasmin Regulatory Post Marketing Surveillance

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Jun 18, 2009
Registry last updated
Nov 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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