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

  • STATUS
    Not Recruiting
  • participants needed
    5000
  • sponsor
    Center for Epidemiology and Health Research, Germany
Updated on 1 September 2021
estradiol
cyproterone acetate

Summary

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

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 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.

Details
Condition Seborrheic dermatitis, Hirsutism, Seborrheic Alopecia, Severe Acne
Clinical Study IdentifierNCT02494297
SponsorCenter for Epidemiology and Health Research, Germany
Last Modified on1 September 2021

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note