Trial Condition(s):

Acne vulgaris

Drug Utilization Study on Diane-35 (and generics) in three European healthcare databases

Bayer Identifier:

17660

ClinicalTrials.gov Identifier:

NCT02349399

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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).

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 Summary

Enrollment Goal
26065
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Diane 35 (EE/CPA, BAY86-5264)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, United Kingdom

Status
Completed
 
Locations

Investigative Site

Many locations, Italy

Status
Completed
 
Locations

Investigative Site

Many locations, Netherlands

Status
Completed
 

Trial Design