Drug Utilization Study on Diane-35 (and Generics) in Three European Healthcare Databases

Bayer26,065 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

26,065

Conditions

Acne Vulgaris

Interventions

Cyproterone / Ethinylestradiol (Diane-35, BAY86-5264) and its GenericsDRUG

Hormonal Contraceptive: Cyproterone Acetate 2 mg / Ethinylestradiol 35 μg

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * The study population will include all female patients registered in the investigated healthcare databases receiving CPA/EE in 2011 or 2012 (first run) or 2014 (second run), without a prescription of CPA/EE in the year prior to index date. Only patients with recorded history in the database of ≥ 365 days prior to index date will be included in the study. Exclusion Criteria: * \<365 days recorded history in the database prior to index date * a prescription of CPA/EE in the year prior to index date

Locations (3)

Unnamed facility

Many Locations, Italy

Unnamed facility

Many Locations, Netherlands

Unnamed facility

Many Locations, United Kingdom

Outcomes

Primary Outcomes

Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of Acne

Time frame: up to 12 months

Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of Hirsutism

Time frame: 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)

Time frame: up to 12 months

Secondary Outcomes

Determination of previous acne treatments (prescription drugs only) of Diane-35 (or generics) users with a previous diagnosis of acne.

Time frame: up to 12 months

Proportion (%) of new Diane-35 (or generics) users, who have concomitant prescriptions of other combined oral contraceptives

Time frame: up to 12 months

Data from ClinicalTrials.gov

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