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

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Cyproterone / Ethinylestradiol (Diane-35, BAY86-5264) and its Generics

• Registration Number: NCT02349399
• Lead Sponsor: Bayer

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-23
• Study First Submitted QC: 2015-01-27
• Study First Posted: 2015-01-28
• Study Start: 2015-05-01
• Primary Completion: 2016-03-01
• Study Completion: 2016-03-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26065

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Drug Utilisation / Cohort 1	Cyproterone / Ethinylestradiol (Diane-35, BAY86-5264) and its Generics	New users of CPA/EE in 2011/2012 and in 2014

Primary Outcome Measures

Name	Time	Method
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 other Hyperandrogenic Conditions (e.g. androgenic alopecia, seborrhea, polycystic ovary syndrome)	up to 12 months
Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of Hirsutism	up to 12 months

Secondary Outcome Measures

Name	Time	Method
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