YAZ Post-marketing Surveillance in Japan

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: June 8, 2011
Last updated: November 13, 2015
Last verified: November 2015
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

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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of adverse events [ Time Frame: During YAZ administration, up to 3 years ] [ Designated as safety issue: Yes ]
  • Unpleasant physical symptoms collection [ Time Frame: Baseline and during YAZ administration, up to 3 years ] [ Designated as safety issue: No ]
  • Unpleasant psychological symptoms collection [ Time Frame: Baseline and during YAZ administration, up to 3 years ] [ Designated as safety issue: No ]
  • Analgesic drug for dysmenorrhea [ Time Frame: During YAZ administration, up to 3 years ] [ Designated as safety issue: No ]
  • QOL survey using Short-Form 36-Item Health Survey (SF-36) [ Time Frame: Baseline and at 6th - 8th cycles (28 datys per cycle) ] [ Designated as safety issue: No ]

Enrollment: 3273
Study Start Date: June 2011
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 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


Genders 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 ClinicalTrials.gov identifier: NCT01375998

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01375998     History of Changes
Other Study ID Numbers: 15328, YAZ-DUI
Study First Received: June 8, 2011
Last Updated: November 13, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:

Additional relevant MeSH terms:
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on December 01, 2015