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

NCT02349399 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 26065

Last updated 2017-04-05

No results posted yet for this study

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).

Conditions

  • Acne Vulgaris

Interventions

DRUG

Cyproterone / Ethinylestradiol (Diane-35, BAY86-5264) and its Generics

Hormonal Contraceptive: Cyproterone Acetate 2 mg / Ethinylestradiol 35 μg

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-01
Primary Completion
2016-03-01
Completion
2016-03-01

Countries

  • Italy
  • Netherlands
  • United Kingdom

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02349399 on ClinicalTrials.gov