Trial Condition(s):
Acne vulgaris
Drug Utilization Study on Diane-35 (and generics) in three European healthcare databases
Bayer Identifier:
17660
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, United Kingdom | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Italy | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Netherlands | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Drug Utilization Study on Diane®-35 (and generics) in European healthcare databases
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of AcneTimeframe: up to 12 months
- Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of HirsutismTimeframe: 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)Timeframe: up to 12 months
Secondary Outcome
- Determination of previous acne treatments (prescription drugs only) of Diane-35 (or generics) users with a previous diagnosis of acne.Timeframe: up to 12 months
- Proportion (%) of new Diane-35 (or generics) users, who have concomitant prescriptions of other combined oral contraceptivesTimeframe: up to 12 months
Additional Information
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