Dysmenorrhea
Conditions
Keywords
YAZ, Dysmenorrhea
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.
Interventions
Patients in daily life treatment receiving YAZ for dysmenorrhea.
Sponsors
Bayer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Unpleasant physical symptoms collection | Baseline and 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) |
| Analgesic drug for dysmenorrhea | During YAZ administration, up to 3 years |
| Unpleasant psychological symptoms collection | Baseline and during YAZ administration, up to 3 years |
| Incidence of adverse events | During YAZ administration, up to 3 years |
Countries
Japan
Outcome results
None listed