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

PCOS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02494297
• Other study ID #: ZEG2014_04
• Status: Completed
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1597
• Est. completion date: October 31, 2016
• Est. primary completion date: October 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Androgenetic Alopecia
• Hirsutism
• PCOS
• Seborrhea
• Severe Anemia

Locations

Country	Name	City	State
Germany	Center of Epidemiology and Health Research	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Center for Epidemiology and Health Research, Germany	Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Clinical Study Synopsis from Bayer AG