YAZ Post-marketing Surveillance in Japan

March 6, 2019 updated by: Bayer

Drug Use Investigation of YAZ

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3273

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Multiple Locations, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The target population of this study is patients who have received a prescription of YAZ on the basis of the decision of the treating gynecologist. The study is expected to collect data of 3,000 patients in about 300 gynecological practices in Japan.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: EE20/DRSP(YAZ, BAY86-5300)
Patients in daily life treatment receiving YAZ for dysmenorrhea.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2011

Primary Completion (Actual)

December 5, 2017

Study Completion (Actual)

March 8, 2018

Study Registration Dates

First Submitted

June 8, 2011

First Submitted That Met QC Criteria

June 17, 2011

First Posted (Estimate)

June 20, 2011

Study Record Updates

Last Update Posted (Actual)

March 7, 2019

Last Update Submitted That Met QC Criteria

March 6, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15328
  • YAZ-DUI (Other Identifier: Company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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