YAZ Post-marketing Surveillance in Japan

• Status: Completed
• Trial end date: 2018-03-08
• Target enrollment: 0
• Participant gender: Female

Summary

This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received YAZ for dysmenorrhea. The objective of this study is to assess safety and efficacy of using YAZ in clinical practice. A total 3,000 patients will be recruited and followed 3 years since starting YAZ administration.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer

Criteria

Inclusion Criteria:

• Patients who received YAZ for dysmenorrhea Additional criteria for QOL questionnaire

• Patient informed consent

Exclusion Criteria:

• Patients who are contraindicated based on the product label Additional criteria for QOL questionnaire

• Six months or less after treatment of estrogen or estrogen combination drug