check_circleStudy Completed
Acne Vulgaris
Bayer Identifier:
17660
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Drug Utilization Study on Diane-35 (and generics) in three European healthcare databases
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).
Key Participants Requirements
Sex
FemaleAge
18 - 64 YearsTrial summary
Enrollment Goal
26065Trial Dates
May 2015 - March 2016Phase
N/ACould I Receive a placebo
NoProducts
Diane 35 (EE/CPA, BAY86-5264)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, United Kingdom | |
Completed | Many locations, Italy | |
Completed | Many locations, Netherlands |
Primary Outcome
- Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of Acnedate_rangeTime Frame:up to 12 monthsenhanced_encryptionNoSafety Issue:
- Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of Hirsutismdate_rangeTime Frame:up to 12 monthsenhanced_encryptionNoSafety Issue:
- 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)date_rangeTime Frame:up to 12 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Determination of previous acne treatments (prescription drugs only) of Diane-35 (or generics) users with a previous diagnosis of acne.date_rangeTime Frame:up to 12 monthsenhanced_encryptionNoSafety Issue:
- Proportion (%) of new Diane-35 (or generics) users, who have concomitant prescriptions of other combined oral contraceptivesdate_rangeTime Frame:up to 12 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A