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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 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)

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

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Starting date: June 2011
Last updated: January 18, 2013

Page last updated: February 07, 2013

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