Clinical trial NCT02494297: DUS on the Prescribing Indications for CPA/EE in 5 European Countries
Official title: Drug Utilization Study on the Prescribing Indications for Cyproterone Acetate and Ethinyl Estradiol in 5 European Countries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hirsutism
Androgenetic Alopecia
Severe Anemia
Seborrhea
PCOS
Lead sponsor: Center for Epidemiology and Health Research, Germany
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2015-07-10
Enrollment: 1597
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who are prescribed Cyproterone Acetate combined with Ethinyl Estradiol during the study period

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Drug Utilization Pattern of Cyproterone Acetate and Ethinyl Estradiol
timeFrame: within 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Center of Epidemiology and Health Research
Study officials:
affiliation: Center for Epidemiology and Health Research Berlin
name: Klaas Heinemann, PhD, MD, MSc, MBA
role: PRINCIPAL_INVESTIGATOR
References: