Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| DI1402 | Other Identifier | Company internal |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study objectives are to characterize new users of Cyproterone Acetate / Ethinylestradiol (CPA/EE) in 2011/2012 and in 2014 according to demographics, treatment characteristics, previous diagnosis of acne, hirsutism or other hyperandrogenic conditions, previous acne treatment and (concomitant) use of hormonal contraceptives identified in Healthcare Databases in the UK (THIN), the Netherlands (PHARMO) and Italy (HSD).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug Utilisation / Cohort 1 | New users of CPA/EE in 2011/2012 and in 2014 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyproterone / Ethinylestradiol (Diane-35, BAY86-5264) and its Generics | Drug | Hormonal Contraceptive: Cyproterone Acetate 2 mg / Ethinylestradiol 35 μg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of Acne | up to 12 months | |
| Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of Hirsutism | up to 12 months | |
| Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of other Hyperandrogenic Conditions (e.g. androgenic alopecia, seborrhea, polycystic ovary syndrome) | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of previous acne treatments (prescription drugs only) of Diane-35 (or generics) users with a previous diagnosis of acne. | up to 12 months | |
| Proportion (%) of new Diane-35 (or generics) users, who have concomitant prescriptions of other combined oral contraceptives |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Women who are new users of CPA/EE in 2011/2012 and in 2014
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Italy | |||||
Not provided
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003534 | Cyproterone |
| D004997 | Ethinyl Estradiol |
| C032640 | Cyproterone acetate, ethinyl estradiol drug combination |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
| up to 12 months |
| Many Locations |
| Netherlands |
| Many Locations | United Kingdom |
| D011083 |
| Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |