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| ID | Type | Description | Link |
|---|---|---|---|
| YAZ-DUI | Other Identifier | Company internal |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EE20/DRSP(YAZ, BAY86-5300) | Drug | Patients in daily life treatment receiving YAZ for dysmenorrhea. |
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| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | During YAZ administration, up to 3 years | |
| Unpleasant physical symptoms collection | Baseline and during YAZ administration, up to 3 years | |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32440228 | Derived | Momoeda M, Akiyama S, Tanaka K, Suzukamo Y. Quality of Life in Japanese Patients with Dysmenorrhea Treated with Ethinylestradiol 20 mug/Drospirenone 3 mg in a Real-World Setting: An Observational Study. Int J Womens Health. 2020 May 4;12:327-338. doi: 10.2147/IJWH.S238460. eCollection 2020. |
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
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| Unpleasant psychological symptoms collection |
| Baseline and 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) |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |