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YAZ Post-marketing Surveillance in Japan

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dysmenorrhea

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

Phase: N/A

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com


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.

Clinical Details

Official title: Drug Use Investigation of YAZ

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome:

Incidence of adverse drug reactions and sever adverse events

Change from baseline in severity of dysmenorrhea at 6th cycles (28 days per cycle)

Secondary outcome:

Incidence of adverse events

Unpleasant physical symptoms collection

Unpleasant psychological symptoms collection

Analgesic drug for dysmenorrhea

QOL survey using Short-Form 36-Item Health Survey (SF-36)


Minimum age: N/A. Maximum age: N/A. Gender(s): Female.


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

Locations and Contacts

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Many locations, Japan; Recruiting
Additional Information

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Starting date: June 2011
Last updated: August 18, 2015

Page last updated: August 23, 2015

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