Drug Utilization Study on Diane®-35 (and Generics) in European Healthcare Databases
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 26,065
- Primary Endpoint
- Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of Acne
Study Overview
Brief Summary
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Drug Utilisation / Cohort 1
New users of CPA/EE in 2011/2012 and in 2014
Intervention: Cyproterone / Ethinylestradiol (Diane-35, BAY86-5264) and its Generics (Drug)
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 other Hyperandrogenic Conditions (e.g. androgenic alopecia, seborrhea, polycystic ovary syndrome)
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
Secondary Outcomes
- Proportion (%) of new Diane-35 (or generics) users, who have concomitant prescriptions of other combined oral contraceptives(up to 12 months)
- Determination of previous acne treatments (prescription drugs only) of Diane-35 (or generics) users with a previous diagnosis of acne.(up to 12 months)