YAZ Post-marketing Surveillance in Japan
Completed
- Conditions
- Dysmenorrhea
- Interventions
- Drug: EE20/DRSP(YAZ, BAY86-5300)
- Registration Number
- NCT01375998
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 3273
Inclusion Criteria
- Patients who received YAZ for dysmenorrhea Additional criteria for QOL questionnaire
- Patient informed consent
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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
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 EE20/DRSP(YAZ, BAY86-5300) -
- Primary Outcome Measures
Name Time Method Incidence of adverse drug reactions and sever adverse events During YAZ administration, up to 3 years Change from baseline in severity of dysmenorrhea at 6th cycles (28 days per cycle) Baseline and during YAZ administration, up to 3 years
- Secondary Outcome Measures
Name Time Method Unpleasant psychological symptoms collection Baseline and during YAZ administration, up to 3 years Unpleasant physical symptoms collection Baseline and during YAZ administration, up to 3 years Incidence of adverse events During YAZ administration, up to 3 years Analgesic drug for dysmenorrhea During YAZ administration, up to 3 years QOL survey using Short-Form 36-Item Health Survey (SF-36) Baseline and at 6th - 8th cycles (28 datys per cycle)