check_circleStudy Completed

Acne Vulgaris

Bayer Identifier:

17660

ClinicalTrials.gov Identifier:

NCT02349399

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

Female

Age

18 - 64 Years
  • - 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.
  • - <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
May 2015 - March 2016
Phase
N/A
Could I Receive a placebo
No
Products
Diane 35 (EE/CPA, BAY86-5264)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
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 Acne
    date_rangeTime Frame:
    up to 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of Hirsutism
    date_rangeTime Frame:
    up to 12 months
    enhanced_encryption
    Safety Issue:
    No
  • 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 months
    enhanced_encryption
    Safety Issue:
    No

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 months
    enhanced_encryption
    Safety Issue:
    No
  • Proportion (%) of new Diane-35 (or generics) users, who have concomitant prescriptions of other combined oral contraceptives
    date_rangeTime Frame:
    up to 12 months
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer products.