DUS on the Prescribing Indications for CPA/EE in 5 European Countries

Drug Utilization Study on the Prescribing Indications for Cyproterone Acetate and Ethinyl Estradiol in 5 European Countries

This study was designed to compile the reasons and specific indications for the prescription of Cyproterone Acetate combined with Ethinyl Estradiol by Health Care Providers. The primary objective of the study was to characterize the prescribing behaviors for Cyproterone Acetate combined with Ethinyl Estradiol in 5 European countries (Austria, Czech Republic, France, the Netherlands, and Spain), including:

• prescription indications for Cyproterone Acetate combined with Ethinyl Estradiol
• use of Cyproterone Acetate combined with Ethinyl Estradiol in accordance with the updated label
• concomitant use of Cyproterone Acetate combined with Ethinyl Estradiol and combined hormonal contraceptives
• second line treatment with Cyproterone Acetate combined with Ethinyl Estradiol for the indication acne

Study Overview

• Status: Completed
• Conditions: PCOS; Androgenetic Alopecia; Seborrhea; Hirsutism; Severe Anemia

Detailed Description

Cyproterone acetate (CPA) 2mg, in combination with ethinyl estradiol (EE) 35mcg, is a medicinal product currently indicated for the treatment of moderate to severe acne in women of reproductive age. Due to the combination with ethinyl estradiol and the dosing, the preparations also act as effective contraceptives.

In 2012, the French health authority conducted a national review of Cyproterone Acetate combined with Ethinyl Estradiol and highlighted serious thromboembolic events and extensive off-label use of these medicines as a contraceptive only. This triggered an Urgent Union Procedure at the beginning of 2013. The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) concluded that the benefits of Cyproterone Acetate combined with Ethinyl Estradiol (cyproterone acetate 2mg / ethinyl estradiol 35mcg) outweigh the risks, providing that several measures are taken to minimize the risk of thromboembolism. These medicines should be used solely for the treatment of moderate to severe acne related to androgen sensitivity and/or hirsutism in women of reproductive age. Since Cyproterone Acetate combined with Ethinyl Estradiol acts as a hormonal contraceptive, women should not take these medicines in combination with hormonal contraceptives. As one of the risk minimization measures, the Market Authorization Holders were required to conduct a number of studies including this drug utilization survey.

This study was a multi-national, cross sectional, prospective, non-interventional, drug utilization study conducted in 5 countries. Study participants were recruited by a network of health care professionals. Physicians collected information from study participants based on questionnaires. This was a one-time survey with no follow-up.

Bayer initiated this study and supported it by an unconditional grant to ZEG. Bayer was not actively involved in the study conduct.

Prolongation of recruitment:

At the beginning of May 2016 the recruitment was finished in 4 of the 5 European countries in which the study was conducted (Austria, Czech Republic, The Netherlands, and Spain). At that point in time, only few patients were enrolled in France because of a delayed recruitment start. Therefore, it was agreed to extend the recruitment phase in France until 31st October 2016, in order to ensure that information on the use of Cyproterone Acetate (combined with Ethinyl Estradiol) would be collected from all participating countries.

• Study Type: Observational
• Enrollment (Actual): 1597

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10115
    • Center of Epidemiology and Health Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women who are prescribed Cyproterone Acetate combined with Ethinyl Estradiol during the study period

Description

Inclusion Criteria:

• Women who are prescribed Cyproterone Acetate combined with Ethinyl Estradiol during the study period
• Women who are willing to participate in the drug utilization study

Exclusion Criteria:

• Women who are not willing to sign the informed consent
• Women with a language barrier

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cyproterone Acetate and Ethinyl Estradiol; Users of Diane 35 (EE/CPA, BAY86-5264)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug Utilization Pattern of Cyproterone Acetate and Ethinyl Estradiol	Information was obtained from doctors prescribing CPA/EE. Categories in the Outcom Measure Data Table below are based on current disease status.	within 18 months

Collaborators and Investigators

• Sponsor: Center for Epidemiology and Health Research, Germany
• Collaborators: Bayer

Publications and helpful links

Helpful Links

• Clinical Study Synopsis from Bayer AG

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 6, 2015
• Primary Completion (ACTUAL): October 31, 2016
• Study Completion (ACTUAL): October 31, 2016

Study Registration Dates

• First Submitted: July 8, 2015
• First Submitted That Met QC Criteria: July 9, 2015
• First Posted (ESTIMATE): July 10, 2015

Study Record Updates

• Last Update Posted (ACTUAL): August 27, 2021
• Last Update Submitted That Met QC Criteria: August 26, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Virilism; Alopecia; Hirsutism
• Other Study ID Numbers: ZEG2014_04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO