YAZ Post-marketing Surveillance in Japan

Bayer

Status: Completed

Conditions: Dysmenorrhea

Treatments: Drug: EE20/DRSP(YAZ, BAY86-5300)

Study type: Observational

Funder types: Industry

Identifiers

NCT01375998

15328

YAZ-DUI (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 3,273 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

3,273 participants in 1 patient group

Group 1

Treatment:

Drug: EE20/DRSP(YAZ, BAY86-5300)