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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02349399

Enrollment

26065

Registered

2015-01-28

Start date

2015-05-01

Completion date

2016-03-01

Last updated

2017-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

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).

Interventions

DRUGCyproterone / Ethinylestradiol (Diane-35, BAY86-5264) and its Generics

Hormonal Contraceptive: Cyproterone Acetate 2 mg / Ethinylestradiol 35 μg

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 64 Years

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

Design outcomes

Primary

Measure	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

Secondary

Measure	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	up to 12 months

Countries

Italy, Netherlands, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026