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

Bayer

Status: Completed

Conditions: Acne Vulgaris

Treatments: Drug: Cyproterone / Ethinylestradiol (Diane-35, BAY86-5264) and its Generics

Study type: Observational

Funder types: Industry

Identifiers

NCT02349399

DI1402 (Other Identifier)

17660

Details and patient eligibility

About

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).

Enrollment: 26,065 patients

Sex: Female

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

26,065 participants in 1 patient group

Drug Utilisation / Cohort 1

Description:

New users of CPA/EE in 2011/2012 and in 2014

Treatment:

Drug: Cyproterone / Ethinylestradiol (Diane-35, BAY86-5264) and its Generics