Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02494297 |
Other study ID # |
ZEG2014_04 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
March 6, 2015 |
Est. completion date |
October 31, 2016 |
Study information
Verified date |
August 2021 |
Source |
Center for Epidemiology and Health Research, Germany |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
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
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.