YAZ Post-marketing Surveillance in Japan

Completed

• Conditions: Dysmenorrhea
• Interventions: Drug: EE20/DRSP(YAZ, BAY86-5300)

• Registration Number: NCT01375998
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-08
• Study Start: 2011-06-09
• Study First Submitted QC: 2011-06-17
• Study First Posted: 2011-06-20
• Primary Completion: 2017-12-05
• Study Completion: 2018-03-08
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3273

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	EE20/DRSP(YAZ, BAY86-5300)	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse drug reactions and sever adverse events	During YAZ administration, up to 3 years
Change from baseline in severity of dysmenorrhea at 6th cycles (28 days per cycle)	Baseline and during YAZ administration, up to 3 years

Secondary Outcome Measures

Name	Time	Method
Unpleasant physical symptoms collection	Baseline and during YAZ administration, up to 3 years
Unpleasant psychological symptoms collection	Baseline and during YAZ administration, up to 3 years
Incidence of adverse events	During YAZ administration, up to 3 years
Analgesic drug for dysmenorrhea	During YAZ administration, up to 3 years
QOL survey using Short-Form 36-Item Health Survey (SF-36)	Baseline and at 6th - 8th cycles (28 datys per cycle)