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YAZ Post-marketing Surveillance in Japan

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Bayer Identifier:
First received: June 8, 2011
Last updated: May 5, 2017
Last verified: May 2017
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.

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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Drug Use Investigation of YAZ

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Incidence of adverse drug reactions and sever adverse events [ Time Frame: 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 ]

Secondary Outcome Measures:
  • Incidence of adverse events [ Time Frame: During YAZ administration, up to 3 years ]
  • Unpleasant physical symptoms collection [ Time Frame: Baseline and during YAZ administration, up to 3 years ]
  • Unpleasant psychological symptoms collection [ Time Frame: Baseline and during YAZ administration, up to 3 years ]
  • Analgesic drug for dysmenorrhea [ Time Frame: 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) ]

Enrollment: 3273
Actual Study Start Date: June 9, 2011
Estimated Study Completion Date: May 15, 2017
Estimated Primary Completion Date: May 15, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: EE20/DRSP(YAZ, BAY86-5300)
Patients in daily life treatment receiving YAZ for dysmenorrhea.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01375998

Many locations, Japan
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT01375998     History of Changes
Other Study ID Numbers: 15328
YAZ-DUI ( Other Identifier: Company internal )
Study First Received: June 8, 2011
Last Updated: May 5, 2017

Keywords provided by Bayer:

Additional relevant MeSH terms:
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Neurologic Manifestations
Signs and Symptoms processed this record on May 24, 2017