Drug Utilization Study on the Prescribing Indications for Cyproterone Acetate and Ethinyl Estradiol in 5 European Countries
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|ClinicalTrials.gov Identifier: NCT02494297|
Recruitment Status : Recruiting
First Posted : July 10, 2015
Last Update Posted : November 3, 2016
This study is 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 is 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
|Condition or disease|
|Hirsutism Seborrheic Alopecia Severe Acne Seborrhea|
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 is a multi-national, cross sectional, prospective, non-interventional, drug utilization study conducted in 5 countries. Study participants will be recruited by a network of health care professionals. Physicians will collect information from study participants based on questionnaires. This is a one-time survey with no follow-up.
Bayer initiated this study and supports it by an unconditional grant to ZEG. Bayer is 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 is 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 till January 2017. This will ensure that information on the use of Cyproterone Acetate (combined with Ethinyl Estradiol) will be collected from all participating countries.
|Study Type :||Observational|
|Estimated Enrollment :||5000 participants|
|Official Title:||Drug Utilization Study on the Prescribing Indications for Cyproterone Acetate and Ethinyl Estradiol in 5 European Countries|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||May 2017|
Cyproterone Acetate and Ethinyl Estradiol
Users of Diane 35 (EE/CPA, BAY86-5264)
- Drug utilization pattern of Cyproterone Acetate and Ethinyl Estradiol [ Time Frame: within 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02494297
|Contact: Karl Pauls, MDfirstname.lastname@example.org|
|Contact: Christine Hagemann, MPHemail@example.com|
|Center of Epidemiology and Health Research||Recruiting|
|Berlin, Germany, 10115|
|Contact: Karl Pauls, MD 00493094510166 firstname.lastname@example.org|
|Contact: Christine Hagemann, MPH 00493094510143 email@example.com|
|Principal Investigator:||Klaas Heinemann, PhD, MD, MSc, MBA||Center for Epidemiology and Health Research Berlin|