YAZ Post-marketing Surveillance in Japan

Dysmenorrhea Clinical Trial

Official title:

Drug Use Investigation of YAZ

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01375998
• Other study ID #: 15328
• Secondary ID: YAZ-DUI
• Status: Completed
• Start date: June 9, 2011
• Est. completion date: March 8, 2018

Study information

• Verified date: March 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3273
• Est. completion date: March 8, 2018
• Est. primary completion date: December 5, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dysmenorrhea

Intervention

Drug:
• EE20/DRSP(YAZ, BAY86-5300)
Patients in daily life treatment receiving YAZ for dysmenorrhea.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse drug reactions and sever adverse events		During YAZ administration, up to 3 years
Primary	Change from baseline in severity of dysmenorrhea at 6th cycles (28 days per cycle)		Baseline and during YAZ administration, up to 3 years
Secondary	Incidence of adverse events		During YAZ administration, up to 3 years
Secondary	Unpleasant physical symptoms collection		Baseline and during YAZ administration, up to 3 years
Secondary	Unpleasant psychological symptoms collection		Baseline and during YAZ administration, up to 3 years
Secondary	Analgesic drug for dysmenorrhea		During YAZ administration, up to 3 years
Secondary	QOL survey using Short-Form 36-Item Health Survey (SF-36)		Baseline and at 6th - 8th cycles (28 datys per cycle)

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