YAZ Post-marketing Surveillance in Japan
Information source: Bayer
Information obtained from ClinicalTrials.gov on February 07, 2013
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
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.
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 eventsChange from baseline in severity of dysmenorrhea at 6th cycles (28 days per cycle)
Secondary outcome: Incidence of adverse eventsUnpleasant physical symptoms collection Unpleasant psychological symptoms collection Analgesic drug for dysmenorrhea QOL survey using Short-Form 36-Item Health Survey (SF-36)
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
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
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: January 18, 2013
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