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YAZ Post-marketing Surveillance in Japan

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ClinicalTrials.gov Identifier: NCT01375998
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief 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.

Condition or disease Intervention/treatment
Dysmenorrhea Drug: EE20/DRSP(YAZ, BAY86-5300)

Study Type : Observational
Actual Enrollment : 3273 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Drug Use Investigation of YAZ
Actual Study Start Date : June 9, 2011
Actual Primary Completion Date : December 5, 2017
Actual Study Completion Date : March 8, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Incidence of adverse drug reactions and sever adverse events [ Time Frame: During YAZ administration, up to 3 years ]
  2. 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 :
  1. Incidence of adverse events [ Time Frame: During YAZ administration, up to 3 years ]
  2. Unpleasant physical symptoms collection [ Time Frame: Baseline and during YAZ administration, up to 3 years ]
  3. Unpleasant psychological symptoms collection [ Time Frame: Baseline and during YAZ administration, up to 3 years ]
  4. Analgesic drug for dysmenorrhea [ Time Frame: During YAZ administration, up to 3 years ]
  5. QOL survey using Short-Form 36-Item Health Survey (SF-36) [ Time Frame: Baseline and at 6th - 8th cycles (28 datys per cycle) ]


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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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01375998


Locations
Japan
Multiple Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01375998     History of Changes
Other Study ID Numbers: 15328
YAZ-DUI ( Other Identifier: Company internal )
First Posted: June 20, 2011    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: April 2018

Keywords provided by Bayer:
YAZ
Dysmenorrhea

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