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

April 4, 2017 updated by: Bayer

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

26065

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women who are new users of CPA/EE in 2011/2012 and in 2014

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Drug Utilisation / Cohort 1
New users of CPA/EE in 2011/2012 and in 2014
Drug: Cyproterone / Ethinylestradiol (Diane-35, BAY86-5264) and its Generics
Hormonal Contraceptive: Cyproterone Acetate 2 mg / Ethinylestradiol 35 μg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of Acne
Time Frame: up to 12 months
up to 12 months
Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of Hirsutism
Time Frame: up to 12 months
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)
Time Frame: up to 12 months
up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Determination of previous acne treatments (prescription drugs only) of Diane-35 (or generics) users with a previous diagnosis of acne.
Time Frame: up to 12 months
up to 12 months
Proportion (%) of new Diane-35 (or generics) users, who have concomitant prescriptions of other combined oral contraceptives
Time Frame: up to 12 months
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

January 23, 2015

First Submitted That Met QC Criteria

January 27, 2015

First Posted (Estimate)

January 28, 2015

Study Record Updates

Last Update Posted (Actual)

April 5, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17660
  • DI1402 (Other Identifier: Company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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