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| ID | Type | Description | Link |
|---|---|---|---|
| YA0910KR | Other Identifier | company internal | |
| YAZ rPMS | Other Identifier | company internal |
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The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EE20/DRSP (YAZ, BAY86-5300) | Drug | Patients under daily life treatment with YAZ according to local drug information. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event collection | After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days) | |
| Contraception efficacy | After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days) | |
| Drug compliance | After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days) | |
| Release of Premenstrual Dysphoric Disorder (PMDD) or acne | After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who used YAZ just for contraception | At initial visit (Day 0) | |
| Number of patients who used YAZ for PMDD + contraception | At initial visit (Day 0) | |
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Inclusion Criteria:
Healthy female subjects
Age: 18 - 50 years
Women who is prescribed YAZ first, during study period
Exclusion Criteria:
Women who are contraindicated based on the label of YAZ
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Korean female who need only contraception or contraception and management of PMDD or contraception and treatment of acne.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | South Korea |
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| ID | Term |
|---|---|
| D011293 | Premenstrual Syndrome |
| D000152 | Acne Vulgaris |
| D065446 | Premenstrual Dysphoric Disorder |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017486 | Acneiform Eruptions |
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| ID | Term |
|---|---|
| C534342 | drospirenone and ethinyl estradiol combination |
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| Number of patients who used YAZ for Acne + contraception |
| At initial visit (Day 0) |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |